Register of Innovative Drugs

Contact: Office of Patented Medicines and Liaison

Products for Human Use - Active Data Protection Period

Medicinal
Ingredient(s) Footnote 1
Submission Number Innovative Drug Manufacturer Drug(s) Containing the Medicinal Ingredient / Variations Notice of Compliance Date yyyy-mm-dd 6 Year
"No File"
Date
Pediatric Extension Yes/No Data Protection Ends
abemaciclib 215268 Verzenio Eli Lilly Canada Inc. N/A 2019-04-05 2025-04-05 N/A 2027-04-05
abrocitinib 245854 Cibinqo Pfizer Canada ULC N/A 2022-06-29 2028-06-29 Yes 2030-12-29
acalabrutinib 214504 Calquence AstraZeneca Canada Inc. Calquence (acalabrutinib maleate) 2019-08-23 2025-08-23 N/A 2027-08-23
ad26.COV2.S (recombinant) 253702 Jcovden Janssen Inc. N/A 2021-11-23 2027-11-23 N/A 2029-11-23
alpelisib 226941 Piqray Novartis Pharmaceuticals Canada Inc. N/A 2020-03-11 2026-03-11 N/A 2028-03-11
amifampridine (supplied as amifampridine phosphate) 232685 Firdapse Kye Pharmaceuticals Inc. N/A 2020-07-31 2026-07-31 N/A 2028-07-31
amivantamab 254440 Rybrevant Janssen Inc. N/A 2022-03-30 2028-03-30 N/A 2030-03-30
andexanet alfa 266464 Ondexxya AstraZeneca Canada Inc. N/A 2023-06-16 2029-06-16 N/A 2031-06-16
mRNA encoding SARS-CoV-2 spike protein, 5'(m7G-5'-ppp-5'-Gm) cap, 100-nucleotide 3' poly(A) tail 275936 Spikevax Moderna Biopharma Canada Corporation N/A 2023-09-12 2029-09-12 Yes 2032-03-12
anifrolumab 246187 Saphnelo AstraZeneca Canada Inc. N/A 2021-11-30 2027-11-30 N/A 2029-11-30
anthrax antigen filtrate 212387 Biothrax Emergent Biodefense Operations Lansing LLC N/A 2018-12-13 2024-12-13 N/A 2026-12-13
anthrax immune globulin (human) 200446 Anthrasil Emergent BioSolutions Canada Inc. N/A 2017-11-06 2023-11-06 Yes 2026-05-06
antihemophilic factor (recombinant), pegylated 189709 Adynovate Takeda Canada Inc. N/A 2016-11-17 2022-11-17 Yes 2025-05-17
antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) 210935 Jivi Bayer Inc. N/A 2018-10-18 2024-10-18 Yes 2027-04-18
antihemophilic factor VIII (recombinant), singlechain (also known as lonoctocog alfa) 190891 Afstyla CSL Behring Canada Inc. N/A 2016-12-12 2022-12-12 Yes 2025-06-12
antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated (turoctocog alfa pegol) 218531 Esperoct Novo Nordisk Canada Inc. N/A 2019-07-04 2025-07-04 Yes 2028-01-04
apalutamide 211942 Erleada Janssen Inc. N/A 2018-07-03 2024-07-03 N/A 2026-07-03
asciminib hydrochloride 255700 Scemblix Novartis Pharmaceuticals Canada Inc. N/A 2022-06-23 2028-06-23 N/A 2030-06-23
atezolizumab 196843 Tecentriq Hoffmann-La Roche Limited N/A 2017-04-12 2023-04-12 Yes 2025-10-12
atogepant 253186 Qulipta Abbvie Corporation N/A 2022-12-22 2028-12-22 N/A 2030-12-22
avacopan 248255 Tavneos Vifor Fresenius Medical Care Renal Pharma Ltd. N/A 2022-04-14 2028-04-14 N/A 2030-04-14
avalglucosidase alfa 245680 Nexviazyme Sanofi-Aventis Canada Inc. N/A 2021-11-12 2027-11-12 Yes 2030-05-12
avapritinib 278913 Ayvakty Blueprint Medicines Corporation N/A 2024-09-18 2030-09-18 N/A 2032-09-18
avatrombopag maleate 251688 Doptelet Swedish Orphan Biovitrum AB (publ) N/A 2023-11-03 2029-11-03 N/A 2031-11-03
avelumab 204052 Bavencio EMD Serono, a Division of EMD Inc., Canada N/A 2017-12-18 2023-12-18 Yes 2026-06-18
axicabtagene ciloleucel 218389 Yescarta Gilead Sciences Canada Inc N/A 2019-02-13 2025-02-13 N/A 2027-02-13
baloxavir marboxil 227361 Xofluza Hoffmann-La Roche Limited N/A 2020-02-19 2026-02-19 Yes 2028-08-19
baricitinib 193687 Olumiant Eli Lilly Canada Inc. N/A 2018-08-17 2024-08-17 N/A 2026-08-17
belumosudil mesylate 245791 Rezurock Sanofi-Aventis Canada Inc. N/A 2022-03-23 2028-03-23 N/A 2030-03-23
belzutifan 254495 Welireg Merck Canada Inc. N/A 2022-07-11 2028-07-11 N/A 2030-07-11
benralizumab 204008 Fasenra AstraZeneca Canada Inc. N/A 2018-02-22 2024-02-22 Yes 2026-08-22
bepotastine besilate 179294 Bepreve Bausch and Lomb Incorporated N/A 2016-07-27 2022-07-27 Yes 2025-01-27
berotralstat (supplied as berotralstat hydrochloride) 252301 Orladeyo BioCryst Pharmaceuticals, Inc. N/A 2022-06-02 2028-06-02 Yes 2030-12-02
bictegravir 203718 Biktarvy Gilead Sciences Canada, Inc. N/A 2018-07-10 2024-07-10 Yes 2027-01-10
bimekizumab 238499 Bimzelx UCB Canada Inc. N/A 2022-02-14 2028-02-14 N/A 2030-02-14
binimetinib 237410 Mektovi Pfizer Canada ULC N/A 2021-03-02 2027-03-02 N/A 2029-03-02
botulism antitoxin heptavalent C/ D/F/ G – (equine) 190645 Bat Emergent BioSolutions Inc. N/A 2016-12-08 2022-12-08 Yes 2025-06-08
brexpiprazole 192684 Rexulti Otsuka Pharmaceutical Co. Ltd. N/A 2017-02-16 2023-02-16 Yes 2025-08-16
brexucabtagene autoleucel 246355 Tecartus Gilead Sciences Canada, Inc. N/A 2021-06-08 2027-06-08 N/A 2029-06-08
brigatinib 210369 Alunbrig Takeda Canada Incorporated N/A 2018-07-26 2024-07-26 N/A 2026-07-26
brodalumab 195317 Siliq Bausch Health, Canada Inc. N/A 2018-03-06 2024-03-06 N/A 2026-03-06
brolucizumab 226224 Beovu Novartis Pharmaceuticals Canada Inc. N/A 2020-03-12 2026-03-12 N/A 2028-03-12
burosumab 216239 Crysvita Kyowa Kirin Inc. N/A 2018-12-05 2024-12-05 Yes 2027-06-05
cabotegravir 227315 Cabenuva ViiV Healthcare ULC Apretude 2020-03-18 2026-03-18 Yes 2028-09-18
cabotegravir sodium 227315 Vocabria ViiV Healthcare ULC Apretude 2020-03-18 2026-03-18 Yes 2028-09-18
cabozantinib (supplied as cabozantinib (S)-malate) 206230 Cabometyx Ipsen Biopharmaceuticals Canada Inc. N/A 2018-09-14 2024-09-14 Yes 2027-03-14
calaspargase pegol 268282 Asparlas Servier Canada Inc. N/A 2023-11-08 2029-11-08 Yes 2032-05-08
calcifediol 205392 Rayaldee Eirgen Pharma Ltd. N/A 2018-07-10 2024-07-10 N/A 2026-07-10
cangrelor tetrasodium 255032 Kengrexal Chiesi Farmaceutici S.p.A N/A 2023-01-20 2029-01-20 N/A 2031-01-20
capivasertib 274859 Truqap AstraZeneca Canada Inc. N/A 2024-01-26 2030-01-26 N/A 2032-01-26
caplacizumab 230001 Cablivi Sanofi-Aventis Canada Inc. N/A 2020-02-28 2026-02-28 N/A 2028-02-28
capmatinib hydrochloride 255972 Tabrecta Novartis Pharmaceuticals Canada Inc. N/A 2022-05-26 2028-05-26 N/A 2030-05-26
cariprazine hydrochloride 249774 Vraylar AbbVie Corporation N/A 2022-04-22 2028-04-22 N/A 2030-04-22
cedazuridine 234610 Inqovi Taiho Pharma Canada, Inc. NA 2020-07-07 2026-07-07 N/A 2028-07-07
cemiplimab 218718 Libtayo Regeneron Canada Company N/A 2019-04-10 2025-04-10 N/A 2027-04-10
cenegermin 218145 Oxervate Dompé farmaceutici S.p.A. N/A 2019-02-08 2025-02-08 N/A 2027-02-08
cenobamate 261689 Xcopri Endo Operations Ltd. N/A 2023-06-12 2029-06-12 N/A 2031-06-12
cerliponase alfa 216539 Brineura Biomarin International Limited N/A 2018-12-19 2024-12-19 Yes 2027-06-19
chAdOx1-S [recombinant] 253700 Vaxzevria AstraZeneca Canada Inc. N/A 2021-11-19 2027-11-19 N/A 2029-11-19
chikungunya virus live-attenuated 275762 Ixchiq Valneva Austria GmbH N/A 2024-06-20 2030-06-20 N/A 2032-06-20
ciltacabtagene autoleucel 262122 Carvykti Janssen Inc. N/A 2023-02-09 2029-02-09 N/A 2031-02-09
clascoterone 265619 Winlevi Sun Pharmaceutical Industries Limited N/A 2023-06-15 2029-06-15 Yes 2031-12-15
coagulation factor IX (recombinant), pegylated (nonacog beta pegol) 201114 Rebinyn Novo Nordisk Canada Inc. N/A 2017-11-29 2023-11-29 Yes 2026-05-29
concizumab 267120 Alhemo Novo Nordisk Canada Inc. N/A 2023-03-10 2029-03-10 Yes 2031-09-10
crisaborole 206906 Eucrisa Pfizer Canada Inc. N/A 2018-06-07 2024-06-07 Yes 2026-12-07
cysteamine bitartrate 191347 Procysbi Horizon Pharma Ireland Ltd. N/A 2017-06-13 2023-06-13 Yes 2025-12-13
daclizumab beta 190458 Zinbryta Biogen Canada Inc. N/A 2016-12-08 2022-12-08 N/A 2024-12-08
dacomitinib 214572 Vizimpro Pfizer Canada Inc. N/A 2019-02-26 2025-02-26 N/A 2027-02-26
dalbavancin (supplied as dalbavancin hydrochloride) 212390 Xydalba Endo Ventures Ltd. N/A 2018-09-04 2024-09-04 Yes 2027-03-04
danicopan 274338 Voydeya Alexion Pharma GmbH N/A 2024-07-19 2030-07-19 N/A 2032-07-19
daridorexant hydrochloride 255507 Quviviq Idorsia Pharmaceuticals Ltd. N/A 2023-04-28 2029-04-28 N/A 2031-04-28
darolutamide 226146 Nubeqa Bayer Inc. N/A 2020-02-20 2026-02-20 N/A 2028-02-20
davesomeran 267589 Spikevax Bivalent (Original/Omicron BA.4/5) Moderna Biopharma Canada Corporation N/A 2022-11-03 2028-11-03 Yes 2031-05-03
defibrotide sodium 200808 Defitelio Jazz Pharmaceuticals Ireland Limited N/A 2017-07-10 2023-07-10 Yes 2026-01-10
deucravacitinib 259397 Sotyktu Bristol-Myers Squibb Canada N/A 2022-11-24 2028-11-24 N/A 2030-11-24
difelikefalin (supplied as difelikefalin acetate) 254548 Korsuva Vifor Fresenius Medical Care Renal Pharma Ltd. N/A 2022-08-16 2028-08-16 N/A 2030-08-16
dinutuximab 212066 Unituxin United Therapeutics Corporation N/A 2018-11-28 2024-11-28 Yes 2027-05-28
doravirine 211293 Pifeltro Merck Canada Inc. Delstrigo 2018-10-12 2024-10-12 Yes 2027-04-12
dostarlimab 251105 Jemperli GlaxoSmithKline Inc. N/A 2021-12-23 2027-12-23 N/A 2029-12-23
dupilumab 201285 Dupixent Sanofi-Aventis Canada Inc. N/A 2017-11-30 2023-11-30 Yes 2026-05-30
durvalumab 202953 Imfinzi AstraZeneca Canada Inc. N/A 2017-11-03 2023-11-03 N/A 2025-11-03
ebola zaire vaccine (rVSVΔG-ZEBOV-GP, live) 256568 Ervebo Merck Canada Inc. N/A 2022-11-09 2028-11-09 N/A 2030-11-09
edaravone 214391 Radicava Mitsubishi Tanabe Pharma Corporation N/A 2018-10-03 2024-10-03 N/A 2026-10-03
edoxaban 187363 Lixiana Servier Canada Inc. N/A 2016-11-04 2022-11-04 Yes 2025-05-04
efgartigimod alfa 267438 Vyvgart Argenx BV N/A 2023-09-19 2029-09-19 N/A 2031-09-19
elagolix 209513 Orilissa AbbVie Corporation N/A 2018-10-05 2024-10-05 N/A 2026-10-05
elasomeran 252733 Spikevax Moderna Biopharma Canada Corporation Spikevax Bivalent
Spikevax Bivalent (Original/Omicron BA.4/5)
2021-09-16 2027-09-16 Yes 2030-03-16
elexacaftor 246955 Trikafta Vertex Pharmaceuticals (Canada) Incorporated N/A 2021-06-18 2027-06-18 Yes 2029-12-18
eliglustat tartrate 183050 Cerdelga Sanofi-Aventis Canada Inc. N/A 2017-04-21 2023-04-21 N/A 2025-04-21
elranatamab 273519 Elrexfio Pfizer Canada ULC N/A 2023-12-06 2029-12-06 N/A 2031-12-06
eluxadoline 190162 Viberzi AbbVie Corporation N/A 2017-01-26 2023-01-26 N/A 2025-01-26
emicizumab 212635 Hemlibra Hoffmann-La Roche Limited N/A 2018-08-02 2024-08-02 Yes 2027-02-02
enasidenib mesylate 217033 Idhifa Celgene Inc. N/A 2019-02-06 2025-02-06 N/A 2027-02-06
encorafenib 237413 Braftovi Pfizer Canada ULC N/A 2021-03-02 2027-03-02 N/A 2029-03-02
enfortumab vedotin 251438 Padcev Seagen Inc. N/A 2021-10-29 2027-10-29 N/A 2029-10-29
entrectinib 227517 Rozlytrek Hoffmann-La Roche Limited N/A 2020-02-10 2026-02-10 Yes 2028-08-10
epcoritamab 271331 Epkinly AbbVie Corporation N/A 2023-10-13 2029-10-13 N/A 2031-10-13
eplontersen sodium 274598 Wainua AstraZeneca Canada Inc. N/A 2024-06-19 2030-06-19 N/A 2032-06-19
eptinezumab 233288 Vyepti Lundbeck Canada Inc. N/A 2021-01-11 2027-01-11 N/A 2029-01-11
erdafitinib 224529 Balversa Janssen Inc. N/A 2019-10-25 2025-10-25 N/A 2027-10-25
erenumab 208607 Aimovig Novartis Pharmaceuticals Canada Inc. N/A 2018-08-01 2024-08-01 N/A 2026-08-01
ertugliflozin 204724 Steglatro Merck Canada Inc. Steglujan
Segluromet
2018-05-09 2024-05-09 N/A 2026-05-09
estetrol monohydrate 236197 Nextstellis Searchlight Pharma Inc. N/A 2021-03-05 2027-03-05 N/A 2029-03-05
etranacogene dezaparvovec 273721 Hemgenix CSL Behring Canada Inc. N/A 2023-10-23 2029-10-23 N/A 2031-10-23
etrasimod L-arginine 271038 Velsipity Pfizer Canada ULC N/A 2024-01-31 2030-01-31 N/A 2032-01-31
evinacumab 272688 Evkeeza Ultragenyx Pharmaceutical Inc. N/A 2023-09-22 2029-09-22 Yes 2032-03-22
exagamglogene autotemcel 284351 Casgevy Vertex Pharmaceuticals (Canada) Incorporated N/A 2024-09-23 2030-09-23 Yes 2033-03-23
famtozinameran 267502 Comirnaty Original & Omicron BA.4/BA.5 BioNTech Manufacturing GmbH N/A 2022-10-07 2028-10-07 Yes 2031-04-07
faricimab 253904 Vabysmo Hoffmann-La Roche Limited N/A 2022-05-27 2028-05-27 N/A 2030-05-27
fedratinib (supplied as fedratinib hydrochloride) 229866 Inrebic Bristol-Myers Squibb Canada N/A 2020-07-27 2026-07-27 N/A 2028-07-27
ferric carboxymaltose 272960 Ferinject Vifor (International) Inc. N/A 2024-03-11 2030-03-11 Yes 2032-09-11
ferric derisomaltose 193890 Monoferric Pharmacosmos A/S N/A 2018-06-22 2024-06-22 Yes 2026-12-22
ferric maltol 260666 Accrufer KYE Pharmaceuticals Inc. N/A 2024-08-21 2030-08-21 N/A 2032-08-21
ferric pyrophosphate citrate 239850 Triferic Avnu Rockwell Medical Inc. N/A 2021-04-22 2027-04-22 Yes 2029-10-22
fidanacogene elaparvovec 275853 Beqvez Pfizer Canada ULC N/A 2023-12-27 2029-12-27 N/A 2031-12-27
finerenone 258231 Kerendia Bayer Inc. N/A 2022-10-14 2028-10-14 N/A 2030-10-14
flibanserin 189352 Addyi Searchlight Pharma Inc. N/A 2018-02-27 2024-02-27 N/A 2026-02-27
florbetaben (18F) 193105 Neuraceq Isologic Innovative Radiopharmaceuticals Ltd. N/A 2017-02-22 2023-02-22 N/A 2025-02-22
follitropin delta 188743 Rekovelle Ferring Inc. N/A 2018-03-22 2024-03-22 N/A 2026-03-22
fostamatinib (supplied as fostamatinib disodium) 232078 Tavalisse Medison Pharma Canada Inc. N/A 2020-11-19 2026-11-19 N/A 2028-11-19
fostemsavir (supplied as fostemsavir tromethamine) 250213 Rukobia ViiV Healthcare ULC N/A 2021-10-01 2027-10-01 N/A 2029-10-01
fremanezumab 226828 Ajovy Teva Canada Limited N/A 2020-04-09 2026-04-09 N/A 2028-04-09
fruquintinib 275803 Fruzaqla Takeda Canada Inc. N/A 2024-09-10 2030-09-10 N/A 2032-09-10
gadoterate meglumine 186333 Dotarem Guerbet N/A 2016-11-26 2022-11-26 Yes 2025-05-26
galcanezumab 219521 Emgality Eli Lilly Canada Inc. N/A 2019-07-30 2025-07-30 N/A 2027-07-30
gemtuzumab ozogamicin 223091 Mylotarg Pfizer Canada ULC N/A 2019-11-28 2025-11-28 Yes 2028-05-28
gilteritinib fumarate 227918 Xospata Astellas Pharma Canada Inc. N/A 2019-12-23 2025-12-23 N/A 2027-12-23
givosiran (supplied as givosiran sodium) 237194 Givlaari Alnylam Netherlands B.V. N/A 2020-10-09 2026-10-09 N/A 2028-10-09
glasdegib 225793 Daurismo Pfizer Canada ULC N/A 2020-04-28 2026-04-28 N/A 2028-04-28
glecaprevir, pibrentasvir 202233 Maviret AbbVie Corporation N/A 2017-08-16 2023-08-16 Yes 2026-02-16
glofitamab 265517 Columvi Hoffmann-La Roche Limited N/A 2023-03-24 2029-03-24 N/A 2031-03-24
guselkumab 200590 Tremfya Janssen Inc. N/A 2017-11-10 2023-11-10 N/A 2025-11-10
hemin 212276 Panhematin Recordati Rare Diseases Canada Inc. N/A 2018-07-13 2024-07-13 N/A 2026-07-13
hepatitis B surface antigen (recombinant) 259302 Prehevbrio VBI Vaccines Inc. N/A 2022-12-06 2028-12-06 N/A 2030-12-06
icosapent ethyl 227235 Vascepa HLS Therapeutics Inc. N/A 2019-12-30 2025-12-30 N/A 2027-12-30
idecabtagene vicleucel 244266 Abecma Celgene Inc. N/A 2021-05-26 2027-05-26 N/A 2029-05-26
imelasomeran 265656 Spikevax Bivalent Moderna Biopharma Canada Corporation N/A 2022-09-01 2028-09-01 Yes 2031-03-01
inclisiran sodium 243470 Leqvio Novartis Pharmaceuticals Canada Inc. N/A 2021-07-26 2027-07-26 N/A 2029-07-26
inebilizumab 271065 Uplizna Horizon Therapeutics Ireland DAC N/A 2023-12-15 2029-12-15 N/A 2031-12-15
infigratinib (supplied as infigratinib phosphate) 246904 Truseltiq QED Therapeutics, Inc. N/A 2021-09-27 2027-09-27 N/A 2029-09-27
inotersen sodium 214274 Tegsedi Akcea Therapeutics Inc. N/A 2018-10-03 2024-10-03 N/A 2026-10-03
inotuzumab ozogamicin 204077 Besponsa Pfizer Canada Inc. N/A 2018-03-15 2024-03-15 N/A 2026-03-15
insulin degludec 198124 Tresiba Novo Nordisk Canada Inc. Xultophy 2017-08-25 2023-08-25 Yes 2026-02-25
insulin icodec 273850 Awiqli Novo Nordisk Canada Inc. N/A 2024-03-12 2030-03-12 N/A 2032-03-12
ioflupane (123I) 201481 Datscan GE Healthcare Canada Inc. N/A 2017-12-07 2023-12-07 N/A 2025-12-07
isatuximab 229245 Sarclisa Sanofi-Aventis Canada Inc. N/A 2020-04-29 2026-04-29 N/A 2028-04-29
isavuconazole (supplied as isavuconazonium sulfate) 208919 Cresemba Avir Pharma Inc. N/A 2018-12-19 2024-12-19 Yes 2027-06-19
ivabradine hydrochloride 166949 Lancora Servier Canada Inc. N/A 2016-12-23 2022-12-23 Yes 2025-06-23
ivosidenib 277139 Tibsovo Servier Canada Inc. N/A 2024-07-19 2030-07-19 N/A 2032-07-19
ixekizumab 184993 Taltz Eli Lilly Canada Inc. N/A 2016-05-25 2022-05-25 Yes 2024-11-25
lanadelumab 213920 Takhzyro Takeda Canada Inc. N/A 2018-09-19 2024-09-19 Yes 2027-03-19
larotrectinib (supplied as larotrectinib sulfate) 219998 Vitrakvi Bayer Inc. N/A 2019-07-10 2025-07-10 Yes 2028-01-10
latanoprostene bunod 211732 Vyzulta Bausch & Lomb Incorporated N/A 2018-12-27 2024-12-27 N/A 2026-12-27
lebrikizumab 272660 Ebglyss Eli Lilly Canada Inc. N/A 2024-06-24 2030-06-24 Yes 2032-12-24
lefamulin acetate 233292 Xenleta Sunovion Pharmaceuticals Canada Inc. N/A 2020-07-10 2026-07-10 N/A 2028-07-10
lemborexant 231286 Dayvigo Eisai Limited N/A 2020-11-04 2026-11-04 N/A 2028-11-04
lenacapavir (supplied as lenacapavir sodium) 262999 Sunlenca Gilead Sciences Canada, Inc. N/A 2022-11-02 2028-11-02 N/A 2030-11-02
letermovir 204165 Prevymis Merck Canada Inc. N/A 2017-11-01 2023-11-01 N/A 2025-11-01
lifitegrast 199810 Xiidra Bausch & Lomb Inc. N/A 2017-12-22 2023-12-22 N/A 2025-12-22
lisocabtagene maraleucel 247562 Breyanzi Bristol-Myers Squibb Canada N/A 2022-05-06 2028-05-06 N/A 2030-05-06
lixisenatide 193862 Adlyxine Sanofi-Aventis Canada Inc. Soliqua 2017-05-25 2023-05-25 N/A 2025-05-25
lorlatinib 215733 Lorbrena Pfizer Canada ULC N/A 2019-02-22 2025-02-22 N/A 2027-02-22
lumasiran (supplied as lumasiran sodium) 254883 Oxlumo Alnylam Netherlands B.V. N/A 2022-03-07 2028-03-07 Yes 2030-09-07
lurbinectedin 247485 Zepzelca Jazz Pharmaceuticals Ireland Limited N/A 2021-09-29 2027-09-29 N/A 2029-09-29
luspatercept 236441 Reblozyl Celgene Inc. N/A 2020-09-25 2026-09-25 N/A 2028-09-25
lutetium (177Lu) oxodotreotide 217184 Lutathera Novartis Pharmaceuticals Canada Inc. N/A 2019-01-09 2025-01-09 N/A 2027-01-09
lutetium (177Lu) vipivotide tetraxetan 260951 Pluvicto Novartis Pharmaceuticals Canada Inc. N/A 2022-08-25 2028-08-25 N/A 2030-08-25
maralixibat chloride 271030 Livmarli Mirum Pharmaceuticals, Inc. N/A 2023-07-21 2029-07-21 Yes 2032-01-21
maribavir 259676 Livtencity Takeda Canada Inc. N/A 2022-09-15 2028-09-15 N/A 2030-09-15
mavacamten 258772 Camzyos Bristol-Myers Squibb Canada N/A 2022-11-08 2028-11-08 N/A 2030-11-08
mecasermin 235023 Increlex Ipsen Biopharmaceuticals Canada Inc. N/A 2020-12-17 2026-12-17 Yes 2029-06-17
metreleptin 273908 Myalepta Chiesi Farmaceutici S.p.A N/A 2024-01-17 2030-01-17 Yes 2032-07-17
midostaurin 201101 Rydapt Novartis Pharmaceuticals Canada Inc. N/A 2017-07-21 2023-07-21 Yes 2026-01-21
migalastat hydrochloride 196956 Galafold Amicus Therapeutics Canada Inc. N/A 2017-09-05 2023-09-05 Yes 2026-03-05
mirikizumab 266471 Omvoh Eli Lilly Canada Inc. N/A 2023-07-20 2029-07-20 N/A 2031-07-20
mogamulizumab 251277 Poteligeo Kyowa Kirin, Inc. N/A 2022-06-02 2028-06-02 N/A 2030-06-02
momelotinib dihydrochloride 281695 Ojjaara GlaxoSmithKline Inc. N/A 2023-11-30 2029-11-30 N/A 2031-11-30
necitumumab 193689 Portrazza Eli Lilly Canada Inc. N/A 2017-03-16 2023-03-16 N/A 2025-03-16
neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rLP2086) subfamily A and Neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rLP2086) subfamily B 195550 Trumenba Pfizer Canada Inc. N/A 2017-10-05 2023-10-05 Yes 2026-04-05
neratinib maleate 218224 Nerlynx Knight Therapeutics Inc. N/A 2019-07-16 2025-07-16 N/A 2027-07-16
netupitant 196495 Akynzeo Knight Therapeutics Inc. N/A 2017-09-28 2023-09-28 N/A 2025-09-28
niraparib 216792 Zejula GlaxoSmithKline Inc. Akeega 2019-06-27 2025-06-27 N/A 2027-06-27
nirmatrelvir 259186 Paxlovid Pfizer Canada ULC N/A 2022-01-17 2028-01-17 N/A 2030-01-17
nirsevimab 269388 Beyfortus AstraZeneca Canada Inc. N/A 2023-04-19 2029-04-19 Yes 2031-10-19
nusinersen 200070 Spinraza Biogen Canada Inc. N/A 2017-06-29 2023-06-29 Yes 2025-12-29
obeticholic acid 198418 Ocaliva Advanz Pharma Canada Inc. N/A 2017-05-24 2023-05-24 Yes 2025-11-24
obiltoxaximab 230825 Anthim Elusys Therapeutics, Inc. N/A 2020-07-30 2026-07-30 N/A 2028-07-30
ocrelizumab 198094 Ocrevus Hoffmann-La Roche Limited N/A 2017-08-14 2023-08-14 N/A 2025-08-14
odevixibat 273741 Bylvay Medison Pharma Canada Inc. N/A 2023-10-30 2029-10-30 Yes 2032-04-30
olaratumab 203478 Lartruvo Eli Lilly Canada Inc. N/A 2017-11-23 2023-11-23 N/A 2025-11-23
olipudase alfa 275236 Xenpozyme Sanofi-Aventis Canada Inc. N/A 2024-02-28 2030-02-28 Yes 2032-08-28
onasemnogene abeparvovec 239719 Zolgensma Novartis Pharmaceuticals Canada Inc. N/A 2020-12-15 2026-12-15 Yes 2029-06-15
ospemifene 222001 Osphena Duchesnay Inc. N/A 2021-07-16 2027-07-16 N/A 2029-07-16
ozanimod (supplied as ozanimod hydrochloride) 232761 Zeposia Bristol-Myers Squibb Canada Co. N/A 2020-10-02 2026-10-02 N/A 2028-10-02
ozenoxacin 192925 Ozanex Ferrer Internacional, S.A. N/A 2017-05-01 2023-05-01 Yes 2025-11-01
palovarotene 252065 Sohonos Ipsen Biopharmaceuticals Canada Inc. N/A 2022-01-21 2028-01-21 Yes 2030-07-21
patiromer sorbitex calcium 210368 Veltassa Vifor Fresenius Medical Care Renal Pharma Ltd. N/A 2018-10-03 2024-10-03 N/A 2026-10-03
patisiran (as patisiran sodium) 221896 Onpattro Alnylam Netherlands B.V. N/A 2019-06-07 2025-06-07 N/A 2027-06-07
pegcetacoplan 263432 Empaveli Swedish Orphan Biovitrium AB (publ) N/A 2022-12-08 2028-12-08 N/A 2030-12-08
pegvaliase 251687 Palynziq BioMarin International Limited N/A 2022-03-30 2028-03-30 Yes 2030-09-30
pemigatinib 242569 Pemazyre Incyte Corporation N/A 2021-09-17 2027-09-17 N/A 2029-09-17
peramivir 191280 Rapivab BioCryst Pharmaceuticals Inc. N/A 2017-01-05 2023-01-05 N/A 2025-01-05
perfluorohexyloctane 272066 Miebo Bausch & Lomb Inc. N/A 2024-09-04 2030-09-04 N/A 2032-09-04
pitolisant hydrochloride 238175 Wakix Endo Ventures Ltd. N/A 2021-05-25 2027-05-25 Yes 2029-11-25
plecanatide 215288 Trulance Bausch Health, Canada Inc. N/A 2019-10-10 2025-10-10 N/A 2027-10-10
pneumococcal polysaccharide serotypes 22F and 33F conjugated to CRM-197. 247042 Vaxneuvance Merck Canada Inc. N/A 2021-11-16 2027-11-16 Yes 2030-05-16
pneumococcal polysaccharide serotypes 8, 10A, 11A, 12F and 15B individually conjugated to CRM197 protein 253111 Prevnar 20 Pfizer Canada ULC N/A 2022-05-09 2028-05-09 Yes 2030-11-09
pneumococcal polysaccharide serotypes 9N, 15A, deOAc15B, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B individually conjugated to CRM197 carrier protein 281914 Capvaxive Merck Canada Inc. N/A 2024-07-15 2030-07-15 N/A 2032-07-15
polatuzumab vedotin 232303 Polivy Hoffmann-La Roche Limited N/A 2020-07-09 2026-07-09 N/A 2028-07-09
ponesimod 239537 Ponvory Janssen Inc. N/A 2021-04-28 2027-04-28 N/A 2029-04-28
pralatrexate 207545 Folotyn Servier Canada Inc. N/A 2018-10-26 2024-10-26 N/A 2026-10-26
pralsetinib 243731 Gavreto Hoffmann-La Roche Limited N/A 2021-06-30 2027-06-30 N/A 2029-06-30
prasterone 198822 Intrarosa Cosette Pharmaceuticals, Inc. N/A 2019-11-01 2025-11-01 N/A 2027-11-01
propiverine hydrochloride 188323 Mictoryl / Mictoryl Pediatric Duchesnay Inc. N/A 2017-01-05 2023-01-05 Yes 2025-07-05
ravulizumab 217955 Ultomiris Alexion Pharma GmbH N/A 2019-08-28 2025-08-28 Yes 2028-02-28
mRNA encoding RSV glycoprotein F stabilized in the prefusion conformation, 5′(m7G-5′-ppp-5′-Gm) cap, 100-nucleotide 3′ poly(A) tail 279310 mResvia Moderna Biopharma Canada Corporation N/A 2024-11-06 2030-11-06 N/A 2032-11-06
mRNA encoding SARS-CoV-2 spike protein, 5' [m27,3'-OGppp(m12'-O)ApG] cap, 110-nucleotide 3' poly(A) tail with a 10-nucleotide linker sequence 276302 Comirnaty BioNTech Manufacturing GmbH N/A 2023-09-28 2029-09-28 N/A 2031-09-28
recombinant haemagglutinin protein-strain A (H1N1)
recombinant haemagglutinin protein-strain A (H3N2)
recombinant haemagglutinin protein-strain B (Victoria)
recombinant haemagglutinin protein-strain B (Yamagata)
235672 Supemtek Sanofi Pasteur Limited N/A 2021-01-14 2027-01-14 N/A 2029-01-14
recombinant human hyaluronidase 247727 Hyqvia Takeda Canada Inc. N/A 2022-01-14 2028-01-14 Yes 2030-07-14
relatlimab 256629 Opdualag Bristol-Myers Squibb Canada N/A 2023-09-13 2029-09-13 Yes 2032-03-13
relugolix 267148 Myfembree Sumitomo Pharma Switzerland GmbH Orgovyx 2023-09-22 2029-09-22 N/A 2031-09-22
remdesivir 240551 Veklury Gilead Sciences Canada, Inc. N/A 2020-07-27 2026-07-27 Yes 2029-01-27
reslizumab 185873 Cinqair Teva Canada Limited N/A 2016-07-20 2022-07-20 Yes 2025-01-20
respiratory syncytial virus prefusion F protein (RSVPreF3) 269021 Arexvy GlaxoSmithKline Inc. N/A 2023-08-04 2029-08-04 N/A 2031-08-04
ribociclib (supplied as ribociclib succinate) 203884 Kisqali Novartis Pharmaceuticals Canada Inc. N/A 2018-03-02 2024-03-02 N/A 2026-03-02
riltozinameran 266189 Comirnaty Original / Omicron BA.1 BioNTech Manufacturing GmbH N/A 2022-10-21 2028-10-21 Yes 2031-04-21
rimegepant 268384 Nurtec ODT Pfizer Canada ULC N/A 2023-12-01 2029-12-01 N/A 2031-12-01
ripretinib 234688 Qinlock Deciphera Pharmaceuticals, LLC N/A 2020-06-19 2026-06-19 N/A 2028-06-19
risankizumab 215753 Skyrizi AbbVie Corporation N/A 2019-04-17 2025-04-17 Yes 2027-10-17
risdiplam 242373 Evrysdi Hoffman-La Roche Limited N/A 2021-04-14 2027-04-14 Yes 2029-10-14
ritlecitinib tosylate 268723 Litfulo Pfizer Canada ULC N/A 2023-11-29 2029-11-29 Yes 2032-05-29
romosozumab 197713 Evenity Amgen Canada Inc. N/A 2019-06-17 2025-06-17 N/A 2027-06-17
RSV subgroup A stabilized prefusion F protein and RSV subgroup B stabilized prefusion F protein 272785 Abrysvo Pfizer Canada ULC N/A 2023-12-21 2029-12-21 Yes 2032-06-21
rupatadine (supplied as rupatadine fumarate) 186488 Rupall Medexus Inc. N/A 2016-07-20 2022-07-20 Yes 2025-01-20
sacituzumab govitecan 248753 Trodelvy Gilead Sciences Canada, Inc. N/A 2021-09-24 2027-09-24 N/A 2029-09-24
safinamide (as safinamide mesylate) 207115 Onstryv Valeo Pharma Inc. N/A 2019-01-10 2025-01-10 N/A 2027-01-10
sarilumab 191745 Kevzara Sanofi-Aventis Canada Inc. N/A 2017-01-12 2023-01-12 N/A 2025-01-12
sars-cov-2 recombinant spike protein 255370 Nuvaxovid Novavax Inc. N/A 2022-02-17 2028-02-17 Yes 2030-08-17
sars-cov-2 recombinant spike protein (omicron XBB.1.5) 278519 Nuvaxovid XBB.1.5 Novavax Inc. N/A 2023-12-05 2029-12-05 N/A 2031-12-05
satralizumab 233642 Enspryng Hoffmann-La Roche Limited N/A 2020-06-01 2026-06-01 Yes 2028-12-01
sebelipase alfa 204085 Kanuma Alexion Pharma GmbH N/A 2017-12-15 2023-12-15 Yes 2026-06-15
selinexor 253182 Xpovio FORUS Therapeutics Inc. N/A 2022-05-31 2028-05-31 N/A 2030-05-31
selpercatinib 243748 Retevmo Loxo Oncology Inc. N/A 2021-06-15 2027-06-15 Yes 2029-12-15
selumetinib sulfate 243733 Koselugo Alexion Pharma GmbH N/A 2022-08-31 2028-08-31 Yes 2031-03-03
semaglutide 202059 Ozempic Novo Nordisk Canada Inc. Rybelsus
Wegovy
2018-01-04 2024-01-04 N/A 2026-01-04
setmelanotide acetate 268412 Imcivree Rhythm Pharmaceuticals, Inc. N/A 2023-05-05 2029-05-05 Yes 2031-11-05
siponimod 223225 Mayzent Novartis Pharmaceuticals Canada Inc. N/A 2020-02-20 2026-02-20 N/A 2028-02-20
sodium zirconium cyclosilicate 218799 Lokelma AstraZeneca Canada Inc. N/A 2019-07-25 2025-07-25 N/A 2027-07-25
solriamfetol hydrochloride 237511 Sunosi Axsome Malta Ltd. N/A 2021-05-13 2027-05-13 N/A 2029-11-13
somapacitan 267443 Sogroya Novo Nordisk Canada Inc. N/A 2023-07-26 2029-07-26 Yes 2032-01-26
somatrogon 246729 Ngenla Pfizer Canada ULC N/A 2021-10-26 2027-10-26 Yes 2030-04-26
sonidegib phosphate 229407 Odomzo Sun Pharmaceutical Industries Ltd. N/A 2020-06-12 2026-06-12 N/A 2028-06-12
sotatercept 283307 Winrevair Merck Canada Inc. N/A 2024-08-28 2030-08-28 N/A 2032-08-28
sotorasib 248435 Lumakras Amgen Canada Inc. N/A 2021-09-10 2027-09-10 N/A 2029-09-10
spesolimab 267362 Spevigo Boehringer Ingelheim (Canada) Ltd. N/A 2023-03-22 2029-03-22 Yes 2031-09-22
sucroferric oxyhydroxide 201492 Velphoro Vifor Fresenius Medical Care Renal Pharma Ltd. N/A 2018-01-05 2024-01-05 N/A 2026-01-05
suvorexant 196367 Belsomra Merck Canada Inc. N/A 2018-11-29 2024-11-29 N/A 2026-11-29
tafamidis meglumine 228368 Vyndaqel Pfizer Canada ULC Vyndamax 2020-01-20 2026-01-20 N/A 2028-01-20
tafasitamab 247025 Minjuvi Incyte Corporation N/A 2021-08-19 2027-08-19 N/A 2029-08-19
talazoparib (supplied as talazoparib tosylate) 220584 Talzenna Pfizer Canada ULC N/A 2019-09-06 2025-09-06 N/A 2027-09-06
talquetamab 278277 Talvey Janssen Inc. N/A 2024-04-30 2030-04-30 N/A 2032-04-30
tarlatamab 281963 Imdelltra Amgen Canada Inc. N/A 2024-09-11 2030-09-11 N/A 2032-09-11
tebentafusp 258717 Kimmtrak Immunocore Ireland Limited N/A 2022-06-07 2028-06-07 N/A 2030-06-07
teclistamab 269369 Tecvayli Janssen Inc. N/A 2023-07-26 2029-07-26 N/A 2031-07-26
tecovirimat monohydrate 247561 Tpoxx Siga Technologies, Inc. N/A 2021-11-29 2027-11-29 Yes 2030-05-29
telotristat ethyl (as telotristat etiprate) 208730 Xermelo SERB SAS N/A 2018-10-10 2024-10-10 N/A 2026-10-10
tenapanor hydrochloride 224850 Ibsrela Knight Therapeutics Inc. N/A 2020-04-15 2026-04-15 N/A 2028-04-15
tepotinib (supplied as tepotinib hydrochloride) 242300 Tepmetko EMD Serono, a Division of EMD Inc., Canada N/A 2021-05-27 2027-05-27 N/A 2029-05-27
tezacaftor 211292 Symdeko Vertex Pharmaceuticals (Canada) Incorporated Trikafta 2018-06-27 2024-06-27 Yes 2026-12-27
tezepelumab 256188 Tezspire AstraZeneca Canada Inc. N/A 2022-07-28 2028-07-28 Yes 2031-01-28
tildrakizumab 224036 Ilumya Sun Pharmaceutical Industries Ltd. N/A 2021-05-19 2027-05-19 N/A 2029-05-19
tipiracil hydrochloride 205852 Lonsurf Taiho Pharma Canada Inc. N/A 2018-01-25 2024-01-25 N/A 2026-01-25
tirbanibulin 262080 Onakta AVIR Pharma Inc. N/A 2023-05-12 2029-05-12 N/A 2031-05-12
tirzepatide 259103 Mounjaro Eli Lilly Canada Inc. N/A 2022-11-24 2028-11-24 N/A 2030-11-24
tisagenlecleucel 213547 /
213698
Kymriah Novartis Pharmaceuticals Canada Inc. N/A 2018-09-05 2024-09-05 Yes 2027-03-05
tixagevimab / cilgavimab 258295 Evusheld AstraZeneca Canada Inc. N/A 2022-04-14 2028-04-14 N/A 2030-04-14
tozinameran 252736 Comirnaty BioNTech Manufacturing GmbH Comirnaty Original & Omicron BA.4/BA.5
Comirnaty Original/Omicron BA.1
2021-09-16 2027-09-16 Yes 2030-03-16
tralokinumab 245877 Adtralza LEO Pharma Inc. N/A 2021-10-13 2027-10-13 Yes 2030-04-13
trastuzumab deruxtecan 242104 Enhertu AstraZeneca Canada Inc. N/A 2021-04-15 2027-04-15 N/A 2029-04-15
tremelimumab 262740 Imjudo AstraZeneca Canada Inc. N/A 2023-08-31 2029-08-31 N/A 2031-08-31
trifarotene 221945 Aklief Galderma Canada Inc. N/A 2019-11-25 2025-11-25 Yes 2028-05-25
triheptanoin 242196 Dojolvi Ultragenyx Pharmaceutical Inc. N/A 2021-02-15 2027-02-15 Yes 2029-08-15
trofinetide 285051 Daybue Acadia Pharmaceuticals Inc. N/A 2024-10-11 2030-10-11 Yes 2033-04-11
tucatinib 235295 Tukysa Seagen Inc. N/A 2020-06-05 2026-06-05 N/A 2028-06-05
ubrogepant 256191 Ubrelvy AbbVie Corporation N/A 2022-11-10 2028-11-10 N/A 2030-11-10
upadacitinib 223734 Rinvoq AbbVie Corporation N/A 2019-12-23 2025-12-23 Yes 2028-06-23
ursodoxicoltaurine 253502 Albrioza Amylyx Pharmaceuticals Inc. N/A 2022-06-10 2028-06-10 N/A 2030-06-10
varicella-zoster virus glycoprotein E (gE) 200244 Shingrix GlaxoSmithKline Inc. N/A 2017-10-13 2023-10-13 N/A 2025-10-13
velpatasvir 190521 Epclusa Gilead Sciences Canada Inc. Vosevi 2016-07-11 2022-07-11 Yes 2025-01-11
vericiguat 240862 Verquvo Bayer Inc. N/A 2023-04-28 2029-04-28 N/A 2031-04-28
vernakalant hydrochloride 190817 Brinavess Cipher Pharmaceuticals Inc. N/A 2017-03-13 2023-03-13 N/A 2025-03-13
virus-like particles (VLP) of sars-cov-2 spike protein 254598 Covifenz Medicago Inc. N/A 2022-02-24 2028-02-24 N/A 2030-02-24
von willebrand factor (recombinant) (vonicog alfa) 213188 Vonvendi Takeda Canada Inc. N/A 2019-01-10 2025-01-10 N/A 2027-01-10
vorasidenib 282910 Voranigo Servier Canada Inc. N/A 2024-08-27 2030-08-27 Yes 2033-02-27
voretigene neparvovec 233097 Luxturna Novartis Pharmaceuticals Canada Inc. N/A 2020-10-13 2026-10-13 Yes 2029-04-13
voxilaprevir 202324 Vosevi Gilead Sciences Canada Inc. N/A 2017-08-16 2023-08-16 N/A 2025-08-16
vutrisiran sodium 267923 Amvuttra Alnylam Netherlands B.V. N/A 2023-10-18 2029-10-18 N/A 2031-10-18
zanubrutinib 242748 Brukinsa BeiGene Switzerland GmbH N/A 2021-03-01 2027-03-01 N/A 2029-03-01
zilucoplan sodium 276757 Zilbrysq UCB Canada Inc. N/A 2024-07-11 2030-07-11 N/A 2032-07-11

Products for Human Use - Expired Data Protection Period

Medicinal
Ingredient(s) Footnote 1
Submission Number Innovative Drug Manufacturer Drug(s) Containing the Medicinal
Ingredient / Variations
Notice of Compliance Date yyyy-mm-dd 6 Year
"No File"
Date
Pediatric Extension Yes/No Data Protection Ends
empagliflozin 162552 Jardiance Boehringer Ingelheim (Canada) Ltd. Synjardy
Glyxambi
2015-07-23 2021-07-23 N/A 2023-07-23
abatacept 098531 Orencia Bristol-Myers Squibb Canada N/A 2006-06-29 2012-06-29 Yes 2014-12-29
abiraterone acetate 138343 Zytiga Janssen Inc. N/A 2011-07-27 2017-07-27 N/A 2019-07-27
acamprosate calcium 103287 Campral Mylan Pharmaceuticals ULC N/A 2007-03-16 2013-03-16 N/A 2015-03-16
aclidinium bromide 157598 Tudorza Genuair AstraZeneca Canada Inc. Duaklir Genuair 2013-07-29 2019-07-29 N/A 2021-07-29
afatinib dimaleate 158730 Giotrif Boehringer Ingelheim (Canada) Ltd. N/A 2013-11-01 2019-11-01 N/A 2021-11-01
aflibercept 149321 Eylea Bayer Inc. N/A 2013-11-08 2019-11-08 N/A 2021-11-08
albiglutide 165145 Eperzan GlaxoSmithKline Inc. N/A 2015-07-15 2021-07-15 N/A 2023-07-15
alectinib hydrochloride 189442 Alecensaro Hoffmann-La Roche Limited N/A 2016-09-29 2022-09-29 N/A 2024-09-29
alglucosidase alfa 103381 Myozyme Genzyme Canada Inc. N/A 2006-08-14 2012-08-14 Yes 2015-02-14
alirocumab 183116 Praluent Sanofi-Aventis Canada Inc. N/A 2016-04-11 2022-04-11 Yes 2024-10-11
aliskiren hemifumarate 105388 Rasilez Novartis Pharmaceuticals Canada Inc. Rasilez HCT
Rasilamlo
2007-11-14 2013-11-14 N/A 2015-11-14
alogliptin benzoate 158335 Nesina Takeda Canada Inc. Kazano
Oseni
2013-11-27 2019-11-27 N/A 2021-11-27
ambrisentan 113287 Volibris GlaxoSmithKline Inc. N/A 2008-03-20 2014-03-20 N/A 2016-03-20
anidulafungin 110202 Eraxis Pfizer Canada Inc. N/A 2007-11-14 2013-11-14 Yes 2016-05-14
antihemophilic factor (recombinant BDD), Fc fusion protein 163447 Eloctate Sanofi-Aventis Canada Inc. N/A 2014-08-22 2020-08-22 Yes 2023-02-22
antihemophilic factor (recombinant, B-domain deleted) (also known as simoctocog alfa) 169551 Nuwiq Octapharma Pharmazeutika Produktionsges.m.b.H N/A 2014-10-23 2020-10-23 Yes 2023-04-23
apixaban 141873 Eliquis Bristol-Myers Squibb Canada N/A 2011-12-16 2017-12-16 Yes 2020-06-16
apremilast 169862 Otezla Amgen Canada Inc. N/A 2014-11-12 2020-11-12 N/A 2022-11-12
aprepitant 108483 Emend Merck Frosst Canada Ltd. Emend Tri-Pack
Emend IV
2007-08-24 2013-08-24 N/A 2015-08-24
aripiprazole 120192 Abilify Bristol-Myers Squibb Canada Abilify Maintena 2009-07-09 2015-07-09 Yes 2018-01-09
asenapine maleate 127427 Saphris Merck Canada Inc. N/A 2011-10-07 2017-10-07 Yes 2020-04-07
asfotase alfa 179340 Strensiq Alexion Pharma International Sàrl N/A 2015-08-14 2021-08-14 Yes 2024-02-14
asunaprevir 172617 Sunvepra Bristol-Myers Squibb Canada N/A 2016-03-09 2022-03-09 N/A 2024-03-09
axitinib 144404 Inlyta Pfizer Canada Inc. N/A 2012-07-12 2018-07-12 Yes 2021-01-12
azacitidine 127108 Vidaza Celgene N/A 2009-10-23 2015-10-23 N/A 2017-10-23
azelastine hydrochloride 169604 Dymista BGP Pharma ULC N/A 2014-10-23 2020-10-23 Yes 2023-04-23
azilsartan medoxomil potassium 145305 Edarbi Valeant Canada LP Edarbyclor 2012-03-08 2018-03-08 N/A 2020-03-08
bazedoxifene acetate 160681 Duavive Pfizer Canada Inc. N/A 2014-10-23 2020-10-23 N/A 2022-10-23
belimumab 137699 Benlysta GlaxoSmithKline Inc. N/A 2011-07-06 2017-07-06 N/A 2019-07-06
bendamustine hydrochloride 149814 Treanda Teva Canada Limited N/A 2012-08-24 2018-08-24 Yes 2021-02-24
besifloxacin 123400 Besivance Bausch & Lomb Inc. N/A 2009-10-23 2015-10-23 Yes 2018-04-23
bilastine 184231 Blexten Aralez Pharmaceutials Canada Inc. N/A 2016-04-21 2022-04-21 Yes 2024-10-21
blinatumomab 181723 Blincyto Amgen Canada Incorporated N/A 2015-12-22 2021-12-22 Yes 2024-06-22
boceprevir 141556 Victrelis Merck Canada Inc. Victrelis Triple 2011-07-29 2017-07-29 N/A 2019-07-29
bosutinib 152211 Bosulif Pfizer Canada Inc. N/A 2014-03-07 2020-03-07 N/A 2022-03-07
brentuximab vedotin 154851 Adcetris Seattle Genetics Inc. N/A 2013-02-01 2019-02-01 N/A 2021-02-01
brivaracetam 183355 Brivlera UCB Canada Incorporated N/A 2016-03-09 2022-03-09 Yes 2024-09-09
bromfenac sodium sesquihydrate 171657 Prolensa Bausch & Lomb Incorporated N/A 2015-03-26 2021-03-26 N/A 2023-03-26
cabazitaxel 137421 Jevtana Sanofi-aventis Canada Inc. N/A 2011-06-16 2017-06-16 Yes 2019-12-16
canagliflozin 157505 Invokana Janssen Inc. Invokamet
Invokamet XR
2014-05-23 2020-05-23 N/A 2022-05-23
canakinumab 131009 Ilaris Novartis Pharmaceuticals Canada Inc. N/A 2010-02-26 2016-02-26 Yes 2018-08-26
carfilzomib 184479 Kyprolis Amgen Canada Inc. N/A 2016-01-15 2022-01-15 N/A 2024-01-15
carglumic acid 171358 Carbaglu Recordati Rare Diseases N/A 2015-04-10 2021-04-10 Yes 2023-10-10
catridecacog 152228 Tretten Novo Nordisk Canada Inc. N/A 2012-07-19 2018-07-19 Yes 2021-01-19
catumaxomab 142629 Removab Fresenius Biotech GmbH N/A 2012-05-11 2018-05-11 N/A 2020-05-11
ceftobiprole medocaril 112752 Zeftera Janssen Inc. N/A 2008-06-26 2014-06-26 N/A 2016-06-26
ceftolozane 178006 Zerbaxa Merck Canada Inc. N/A 2015-09-30 2021-09-30 N/A 2023-09-30
ceritinib 175702 Zykadia Novartis Pharmaceuticals Canada Inc. N/A 2015-03-27 2021-03-27 N/A 2023-03-27
certolizumab pegol 120296 Cimzia UCB Canada Inc. N/A 2009-08-12 2015-08-12 N/A 2017-08-12
ciclesonide 101419 Alvesco Takeda Canada Inc. Omnaris
Omnaris HFA
2006-09-11 2012-09-11 Yes 2015-03-11
clevidipine 125287 Cleviprex Chiesi Farmaceutici S.p.A. N/A 2011-04-15 2017-04-15 N/A 2019-04-15
clofarabine 121874 Clolar Sanofi-aventis Canada Inc. N/A 2009-07-16 2015-07-16 Yes 2018-01-16
coagulation factor IX (recombinant), albumin fusion protein (rIX-FP) 180793 Idelvion CSL Behring Canada Inc. N/A 2016-01-26 2022-01-26 Yes 2024-07-26
coagulation factor IX, Fc fusion protein 163614 Alprolix Sanofi-Aventis Canada Inc. N/A 2014-03-20 2020-03-20 Yes 2022-09-20
cobimetinib 182788 Cotellic Hoffmann-La Roche Limited N/A 2016-02-22 2022-02-22 N/A 2024-02-22
colesevelam hydrochloride 133463 Lodalis Valeant Canada LP / Valeant Canada S.E.C. N/A 2011-09-22 2017-09-22 N/A 2019-09-22
collagenase clostridium histolyticum 147788 Xiaflex Endo Ventures Ltd. N/A 2012-07-05 2018-07-05 N/A 2020-07-05
crizotinib 145155 Xalkori Pfizer Canada Inc. N/A 2012-04-25 2018-04-25 Yes 2020-10-25
dabigatran etexilate mesilate 114887 Pradaxa Boehringer Ingelheim (Canada) Ltd. N/A 2008-06-10 2014-06-10 N/A 2016-06-10
dabrafenib mesylate 157590 Tafinlar Novartis Pharmaceuticals Canada Inc. N/A 2013-07-16 2019-07-16 N/A 2021-07-16
daclatasvir 172616 Daklinza Bristol-Myers Squibb Canada N/A 2015-08-13 2021-08-13 N/A 2023-08-13
dapagliflozin propanediol 160877 Forxiga AstraZeneca Canada Inc. Xigduo
Qtern
2014-12-12 2020-12-12 N/A 2022-12-12
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Genvoya
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Lotemax Ointment
Lotemax Gel
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Phesgo
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pneumococcal polysaccharide serotype 1, 4, 5, 6B, 7F, 9V, 14, 23F conjugated to protein D carrier protein; serotype 18C conjugated to tetanus toxoid carrier protein; serotype 19F conjugated to diphtheria toxoid carrier protein
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Odefsey
Juluca
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Odefsey
Vemlidy
Symtuza
Biktarvy"
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turoctocog alfa 170796 Zonovate Novo Nordisk Canada Inc. N/A 2014-12-08 2020-12-08 Yes 2023-06-08
ulipristal acetate 156861 Fibristal Allergan Inc. N/A 2013-06-24 2019-06-24 N/A 2021-06-24
umeclidinium bromide 161585 Anoro Ellipta GlaxoSmithKline Inc. Incruse Ellipta 2013-12-23 2019-12-23 N/A 2021-12-23
ustekinumab 114272 Stelara Janssen Inc. N/A 2008-12-12 2014-12-12 N/A 2016-12-12
vandetanib 126822 Caprelsa Genzyme Canada, a division of Sanofi-aventis Canada Inc. N/A 2012-01-12 2018-01-12 N/A 2020-01-12
varenicline tartrate 104007 Champix Pfizer Canada Inc. N/A 2007-01-24 2013-01-24 Yes 2015-07-24
vedolizumab 169414 Entyvio Takeda Canada Inc. N/A 2015-01-29 2021-01-29 Yes 2023-07-29
velaglucerase alfa 132604 Vpriv Shire Human Genetic Therapies, Inc. N/A 2010-10-01 2016-10-01 Yes 2019-04-01
vemurafenib 148693 Zelboraf Hoffmann-La Roche Ltd. N/A 2012-02-15 2018-02-15 N/A 2020-02-15
venetoclax 190761 Venclexta AbbVie Corporation N/A 2016-09-30 2022-09-30 N/A 2024-09-30
vilanterol trifenatate 157301 Breo Ellipta GlaxoSmithKline Inc. Anoro Ellipta
Trelegy Ellipta
2013-07-03 2019-07-03 Yes 2022-01-03
vilazodone hydrochloride 176820 Viibryd AbbVie Corporation N/A 2015-07-16 2021-07-16 Yes 2024-01-16
vismodegib 154608 Erivedge Hoffmann-La Roche Ltd. N/A 2013-07-12 2019-07-12 N/A 2021-07-12
vorapaxar sulfate 179320 Zontivity Xspire Pharma, LLC N/A 2016-05-13 2022-05-13 N/A 2024-05-13
vorinostat 104562 Zolinza Merck Frosst Canada Ltd. N/A 2009-06-11 2015-06-11 N/A 2017-06-11
vortioxetine hydrobromide 159019 Trintellix Lundbeck Canada Inc. N/A 2014-10-22 2020-10-22 Yes 2023-04-22
ziprasidone hydrochloride monohydrate 078188 Zeldox Pfizer Canada Inc. N/A 2007-08-27 2013-08-27 Yes 2016-02-27
zucapsaicin 121952 Zuacta Sanofi-aventis Canada Inc. N/A 2010-07-15 2016-07-15 N/A 2018-07-15
zilucoplan sodium 276757 Zilbrysq UCB Canada Inc. N/A 2024-07-11 2030-07-11 N/A 2032-07-11
Products for Veterinary Use - Active Data Protection Period
Medicinal
Ingredient(s) Footnote 1
Submission
Number
Innovative Drug Manufacturer Drug(s) Containing the Medicinal Ingredient / Variations Notice of Compliance Date yyyy-mm-dd 6 Year
"No File"
Date
Data Protection Ends
amlodipine besilate 218786 Amodip Flavoured Tablets Ceva Animal Health Inc. N/A 2020-03-25 2026-03-25 2028-03-25
bupivacaine hydrochloride 254222 Tri-Solfen Dechra Ltd. N/A 2022-06-21 2028-06-21 2030-06-21
bedinvetmab 237723 Librela Zoetis Canada Inc. N/A 2021-02-01 2027-02-01 2029-02-01
capromorelin tartrate 259520 Elura Elanco Canada Limited N/A 2024-06-03 2030-06-03 2032-06-03
ciclesonide 200882 Aservo Equihaler Boehringer Ingelheim Animal Health Canada Inc. N/A 2020-04-30 2026-04-30 2028-04-30
frunevetmab 242879 Solensia Zoetis Canada Inc. N/A 2021-07-27 2027-07-27 2029-07-27
gonadorelin[6-D-Phe] acetate 256977 Gonavet Modern Veterinary Therapeutics LLC N/A 2022-10-20 2028-10-20 2030-10-20
grapiprant 211760 Galliprant Elanco Canada Limited N/A 2019-01-08 2025-01-08 2027-01-08
ilunocitinib 270696 Zenrella Elanco Canada Limited N/A 2024-09-25 2030-09-25 2032-09-25
isoeugenol 252779 Aqui-S AQUI-S New Zealand Ltd. N/A 2023-07-31 2029-07-31 2031-07-31
lotilaner 193712 Credelio Elanco Canada Limited Credelio Plus
Credelio Cat
2017-12-29 2023-12-29 2025-12-29
lubabegron 166199 Experior 10 Elanco Canada Limited Experior 50 2018-11-07 2024-11-07 2026-11-07
methadone hydrochloride 226217 Comfortan Eurovet Animal Health B.V. N/A 2020-02-25 2026-02-25 2028-02-25
midazolam 230770 Dormazolam Dechra Regulatory BV N/A 2021-06-29 2027-06-29 2029-06-29
mirtazapine 232197 Mirataz Dechra Ltd. N/A 2020-09-08 2026-09-08 2028-09-08
peforelin 190986 Maprelin XP-10 Modern Veterinary Therapeutics LLC N/A 2017-06-19 2023-06-19 2025-06-19
spironolactone 263787 Cardalis Ceva Animal Health Inc. N/A 2023-10-11 2029-10-11 2031-10-11
tetracosactide 228462 Cosacthen Dechra Ltd. N/A 2020-04-27 2026-04-27 2028-04-27
vatinoxan hydrochloride 256567 Zenalpha Dechra Veterinary Products Inc. N/A 2023-05-01 2029-05-01 2031-05-01
velagliflozin L-proline monohydrate 265785 Senvelgo Boehringer Ingelheim Animal Health Canada Inc. N/A 2023-11-28 2029-11-28 2031-11-28

Products for Veterinary Use - Expired Data Protection Period

Medicinal Ingredient(s) Footnote 1 Submission
Number
Innovative Drug Manufacturer Drug(s) Containing the Medicinal Ingredient / Variations Notice of Compliance Date yyyy-mm-dd 6 Year "No File"
Date
Data Protection Ends
acetaminophen 110139 Pracetam 20% O.S. Ceva Animal Health Inc. N/A 2009-03-05 2015-03-05 2017-03-05
afoxolaner 163768 Nexgard Boehringer Ingelheim Animal Health Canada Inc. Nexgard Spectra
Nexgard Combo
2014-07-08 2020-07-08 2022-07-08
avilamycin 156949 Surmax 100 Premix Elanco Canada Limited Surmax 200 Premix 2014-02-18 2020-02-18 2022-02-18
buprenorphine hydrochloride 126077 Vetergesic Multidose Sogeval UK Limited N/A 2010-02-03 2016-02-03 2018-02-03
cefovecin sodium 110061 Convenia Zoetis Canada Inc. N/A 2007-05-30 2013-05-30 2015-05-30
cefpodoxime proxetil 149164 Simplicef Zoetis Canada Inc. N/A 2012-12-06 2018-12-06 2020-12-06
cephalexin monohydrate 126970 Vetolexin Vétoquinol N.-A Inc. Cefaseptin 2010-06-24 2016-06-24 2018-06-24
clodronate disodium tetrahydrate 172789 Osphos Injection Dechra Ltd. N/A 2015-05-06 2021-05-06 2023-05-06
closantel sodium 180678 Flukiver Elanco Division Eli Lilly Canada Inc. N/A 2015-11-24 2021-11-24 2023-11-24
derquantel 184844 Startect Zoetis Canada Inc. N/A 2016-04-27 2022-04-27 2024-04-27
dibotermin alfa (rhBMP-2) 148153 Truscient Zoetis Canada Inc. N/A 2012-11-20 2018-11-20 2020-11-20
dirlotapide 110110 Slentrol Zoetis Canada Inc. N/A 2008-08-14 2014-08-14 2016-08-14
emamectin benzoate 109976 Slice Intervet Canada Ltd. N/A 2009-06-29 2015-06-29 2017-06-29
emodepside 112103 / 112106 / 112107 Profender Bayer Healthcare, Animal Health Division N/A 2008-08-28 2014-08-28 2016-08-28
firocoxib 110661 / 110379 Previcox Merial Canada Inc. N/A 2007-09-28 2013-09-28 2015-09-28
fluoxetine hydrochloride 109825 / 109826 / 110429 Reconcile Elanco, Division Eli Lilly Canada Inc. N/A 2008-03-28 2014-03-28 2016-03-28
fluralaner 166320 Bravecto Intervet Canada Corp. Vitrecto
Bravecto One
2014-05-23 2020-05-23 2022-05-23
gamithromycin 125823 Zactran Merial Canada Inc. N/A 2010-03-29 2016-03-29 2018-03-29
gonadotropin releasing factor analogue - protein conjugate 140525 Improvest Zoetis Canada Inc. N/A 2011-06-22 2017-06-22 2019-06-22
ibafloxacin 110655 / 110657 Ibaflin gel Intervet Canada Ltd. N/A 2008-01-15 2014-01-15 2016-01-15
insulin human (recombinant) 150211 Prozinc Boehringer Ingelheim Animal Health Canada N/A 2013-04-24 2019-04-24 2021-04-24
imidapril hydrochloride 110445 / 110450 / 110476 Prilium Vetoquinol N A Inc. N/A 2007-07-12 2013-07-12 2015-07-12
itraconazole 109769 Itrafungol Elanco, Division Eli Lilly Canada Inc. N/A 2008-09-23 2014-09-23 2016-09-23
maropitant 110342 / 110344 / 110347 / 110348 Cerenia Zoetis Canada Inc. N/A 2007-09-20 2013-09-20 2015-09-20
mitratapide 111600 Yarvitan Janssen Pharmaceutica N.V. N/A 2009-02-20 2015-02-20 2017-02-20
mometasone furoate monohydrate 110289 Mometamax Intervet Canada Corp. N/A 2010-02-22 2016-02-22 2018-02-22
oclacitinib maleate 159090 Apoquel Zoetis Canada Inc. N/A 2014-07-15 2020-07-15 2022-07-15
pegbovigrastim 148171 Imrestor Elanco Division Eli Lilly Canada Inc. N/A 2016-03-09 2022-03-09 2024-03-09
pergolide mesylate 158770 Prascend Boehringer Ingelheim Animal Health Canada Inc. N/A 2013-09-05 2019-09-05 2021-09-05
permethrin 133818 Oridermyl Vétoquinol N.- A Inc. N/A 2011-02-18 2017-02-18 2019-02-18
phenobarbital 142445 Epiphen Vétoquinol N.-A Inc. N/A 2012-04-04 2018-04-04 2020-04-04
pradofloxacin 161227 Veraflox Elanco Canada Limited N/A 2015-01-29 2021-01-29 2023-01-29
ramipril 110296 / 110297 / 110298 Vasotop Intervet Canada Ltd. N/A 2008-09-05 2014-09-05 2016-09-05
robenacoxib 128703 Onsior Elanco Canada Limited N/A 2011-10-03 2017-10-03 2019-10-03
sevoflurane 110109 Sevoflo Zoetis Canada Inc. N/A 2008-03-28 2014-03-28 2016-03-28
sarolaner 177679 Simparica Zoetis Canada Inc. Revolution Plus
Simparica Trio
2016-02-11 2022-02-11 2024-02-11
telmisartan 158760 Semintra Boehringer Ingelheim Animal Health Canada Inc. N/A 2013-12-12 2019-12-12 2021-12-12
spinosad 112198 / 112199 / 112202 / 112203 / 112204 Comfortis Elanco, Division Eli Lilly Canada Inc. Trifexis 2009-08-24 2015-08-24 2017-08-24
tepoxalin 109950 / 109956 / 109963 Zubrin Schering Plough Canada Inc. N/A 2007-10-01 2013-10-01 2015-10-01
terbinafine 170344 Osurnia Dechra Ltd. N/A 2015-03-26 2021-03-26 2023-03-26
thiamazole 125706 Felimazole Dechra Ltd. N/A 2009-08-25 2015-08-25 2017-08-25
tildipirosin 148052 Zuprevo Intervet Canada Corp. N/A 2012-06-13 2018-06-13 2020-06-13
tiludronic acid (as tiludronate disodium) 171467 Tildren CEVA Animal Health N/A 2014-12-22 2020-12-22 2022-12-22
toceranib phosphate 123643 Palladia Zoetis Canada Inc. N/A 2009-12-01 2015-12-01 2017-12-01
toltrazuril 122525 Baycox Bayer Inc., Bayer Healthcare Animal Health Division N/A 2010-08-20 2016-08-20 2018-08-20
trilostane 110023 / 110025 / 110221 / 113566 Vetoryl Dechra Ltd. N/A 2009-01-30 2015-01-30 2017-01-30
triptorelin (as triptorelin acetate) 161303 Ovugel United-AH II, LLC N/A 2014-04-25 2020-04-25 2022-04-25
tulathromycin 112161 Draxxin Pfizer Canada Inc., Animal Health Group N/A 2006-08-31 2012-08-31 2014-08-31
zilpaterol hydrochloride 110019 Zilmax Intervet Canada Ltd. N/A 2009-03-18 2015-03-18 2017-03-18

Background

The Register of Innovative Drugs is maintained pursuant to subsection C.08.004.1(9) of the Food and Drug Regulations. The register indicates the drugs that are eligible for data protection. Under subsection C.08.004.1(3) a subsequent manufacturer that seeks a notice of compliance on the basis of a direct or indirect comparison between the new drug and an innovative drug may not file a submission before the end of a period of six years after the day on which the first notice of compliance was issued for the innovative new drug. In addition, the notice of compliance cannot be issued before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator.

The format of the Register of Innovative Drugs is an electronic table, which is updated weekly. The register lists, in alphabetical order, the medicinal ingredients in the innovative drugs which were not previously approved in a drug by the Minister and that are not variations of a previously approved medicinal ingredient. Please note that there may be other medicinal ingredients included in the drugs. The register was re-formatted in summer 2016 to increase the clarity of the information provided regarding the medicinal ingredient, brand name and manufacturer of each innovative drug.

For more information

For information related to treatment options, choices of medications and their uses, illnesses, side effects or drug interactions, please contact your health care professional (for example, doctor, pharmacist, etc.). We do not provide medical advice regarding the use of the products identified in this database.

For other comments or questions, please contact the:

Office of Patented Medicines and Liaison
Email: opml-bmbl@hc-sc.gc.ca
Telephone: 613-941-7281

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