Certificates of Supplementary Protection (CSP) and Applications
- The fee as of April 1, 2023 is $10,152
- Register of Certificates of Supplementary Protection and Applications
- Guidance Document: Certificate of Supplementary Protection Regulations - summary
- Notice: Publication of update to the Guidance Document: Certificate of Supplementary Protection Regulations
- CSP Application Form (effective January 6, 2021)
- CSP Application Form (effective April 1, 2020 to January 5, 2021)
- CSP Application Form (effective May 15, 2019 to March 31, 2020)
- CSP Application Form (effective September 22, 2018 to May 14, 2019)
- CSP Application Form (from September 21, 2017 to September 21, 2018)
- Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications
- How to Pay Fees to Health Products and Food Branch (HPFB)
- Background
Register of Certificates of Supplementary Protection and Applications
Certificate of Supplementary Protection (CSP) and/or Application Number | Medicinal Ingredient(s) | New Drug Submission (NDS) Number | Patent Number | Patent Expiry Date yyyy-mm-dd |
Application Status | CSP Term Begins yyyy-mm-dd |
CSP Term Ends yyyy-mm-dd |
---|---|---|---|---|---|---|---|
900039 | abemaciclib | 215268 | 2747055 | 2029-12-15 | Issued | 2029-12-16 | 2031-12-15 |
900096 | abrocitinib | 245854 | 2900703 | 2034-02-11 | Issued | 2034-02-12 | 2036-02-11 |
900045 | acalabrutinib | 214504 | 2841886 | 2032-07-11 | Issued | 2032-07-12 | 2034-07-11 |
900056 | alpelisib | 226941 | 2734819 | 2029-09-08 | Issued | 2029-09-09 | 2031-09-08 |
900114 | amivantamab | 254440 | 2893505 | 2033-11-21 | Issued | 2033-11-22 | 2035-11-21 |
900089 | anifrolumab | 246187 | 2713981 | 2029-02-06 | Withdrawn | N/A | N/A |
900035 | antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) | 210935 | 2586379 | 2025-11-14 | Issued | 2025-11-15 | 2027-11-14 |
900027 | apalutamide | 211942 | 2875767 | 2033-06-04 | Issued | 2033-06-05 | 2033-07-04 |
900100 | asciminib hydrochloride | 255700 | 2868958 | 2033-05-09 | Issued | 2033-05-10 | 2035-05-09 |
900113 | atogepant | 253186 | 2817100 | 2031-11-10 | Issued | 2031-11-11 | 2033-11-10 |
900095 | avacopan | 248255 | 2747522 | 2029-12-21 | Issued | 2029-12-22 | 2031-12-21 |
900088 | avelumab | 204052 | 2856895 | 2032-11-21 | Issued | 2032-11-22 | 2032-12-19 |
900026 | baricitinib | 193687 | 2718271 | 2029-03-10 | Issued | 2029-03-11 | 2031-03-10 |
900102 | belumosudil mesylate | 245791 | 2926478 | 2033-10-07 | Issued | 2033-10-08 | 2035-10-07 |
900103 | belzutifan | 254495 | 2919397 | 2034-09-05 | Issued | 2034-09-06 | 2036-09-05 |
900012 | benralizumab | 204008 | 2685222 | 2028-05-14 | Issued | 2028-05-15 | 2030-05-14 |
900093 | bimekizumab | 238499 | 2823812 | 2032-01-11 | Issued | 2032-01-12 | 2034-01-11 |
900028 | bictegravir sodium / emtricitabine / tenofovir alafenamide hemifumarate | 203718 | 2416757 | 2021-07-20 | Refused | N/A | N/A |
900020 | brigatinib | 210369 | 2723961 | 2029-05-21 | Issued | 2029-05-22 | 2031-05-21 |
900015 | brodalumab | 195317 | 2663537 | 2027-10-01 | Issued | 2027-10-02 | 2029-10-01 |
900060 | brolucizumab | 226224 | 2727839 | 2029-06-25 | Issued | 2029-06-26 | 2031-06-25 |
900057 | cabotegravir (cabotegravir sodium) | 227315 | 2606282 | 2026-04-28 | Issued | 2026-04-29 | 2028-04-28 |
900097 | cabotegravir / rilpivirine | 227315 | 3060290 | 2031-01-24 | Issued | 2031-01-25 | 2033-01-24 |
900063 | cedazuridine / decitabine | 234610 | 2702274 | 2028-10-16 | Issued | 2028-10-17 | 2030-10-16 |
900022 | cenegermin | 218145 | 2346257 | 2019-10-11 | Refused | N/A | N/A |
900118 | ciltacabtagene autoleucel | 262122 | 3019453 | 2037-08-10 | Issued | 2037-08-11 | 2038-02-10 |
900011 | coagulation factor IX (recombinant), pegylated | 201114 | 2462930 | 2022-10-09 | Refused | N/A | N/A |
900052 | coagulation factor IX (recombinant), pegylated | 201114 | 2665480 | 2027-10-04 | Refused | N/A | N/A |
900115 | concizumab | 267120 | 2745317 | 2029-12-18 | Issued | 2029-12-19 | 2031-12-18 |
900084 | COVID-19 vaccine (ChAdOx1-S [recombinant]) | 252495 | 2837274 | 2032-05-25 | Refused | N/A | N/A |
900019 | crisaborole | 206906 | 2597982 | 2026-02-16 | Issued | 2026-02-17 | 2028-02-16 |
900041 | dacomitinib | 214572 | 2565812 | 2025-04-25 | Issued | 2025-04-26 | 2027-04-25 |
900119 | daridorexant hydrochloride | 255507 | 2873341 | 2033-06-03 | Issued | 2033-06-04 | 2035-06-03 |
900058 | darolutamide | 226146 | 2777896 | 2030-10-27 | Issued | 2030-10-28 | 2032-10-27 |
900017 | darunavir ethanolate / cobicistat / emtricitabine / tenofovir alafenamide hemifumarate | 199705 | 2678907 | 2028-02-22 | Issued | 2028-02-23 | 2030-02-22 |
900110 | deucravacitinib | 259397 | 2890981 | 2033-11-07 | Issued | 2033-11-08 | 2035-11-07 |
900106 | difelikefalin (difelikefalin acetate) | 254548 | 2667155 | 2027-11-12 | Issued | 2027-11-13 | 2029-11-12 |
900051 | dolutegravir (dolutegravir sodium) / lamivudine | 220275 | 3003988 | 2031-01-24 | Issued | 2031-01-25 | 2033-01-24 |
900021 | dolutegravir (dolutegravir sodium) / rilpivirine (rilpivirine hydrochloride) | 206402 | 2606282 | 2026-04-28 | Refused | N/A | N/A |
900034 | doravirine | 211293 | 2794377 | 2031-03-28 | Issued | 2031-03-29 | 2033-03-28 |
900004 | dupilumab | 201285 | 2737044 | 2029-10-27 | Issued | 2029-10-28 | 2031-10-27 |
900010 | durvalumab | 202953 | 2778714 | 2030-11-24 | Issued | 2030-11-25 | 2032-11-04 |
900024 | emicizumab | 212635 | 2817964 | 2031-11-17 | Issued | 2031-11-18 | 2033-08-03 |
900053 | entrectinib | 227517 | 2693901 | 2028-07-08 | Issued | 2028-07-09 | 2030-07-08 |
900074 | eptinezumab | 233288 | 2836649 | 2032-05-21 | Issued | 2032-05-22 | 2034-05-21 |
900070 | erdafitinib | 224529 | 2796204 | 2031-04-28 | Issued | 2031-04-29 | 2033-04-28 |
900025 | erenumab | 208607 | 2746858 | 2029-12-18 | Issued | 2029-12-19 | 2031-12-18 |
900018 | ertugliflozin | 204724 | 2733795 | 2029-08-17 | Issued | 2029-08-18 | 2031-08-17 |
900076 | estetrol monohydrate / drospirenone | 236197 | 2448278 | 2022-05-23 | Issued | 2022-05-24 | 2024-05-23 |
900099 | faricimab | 253904 | 2874554 | 2033-07-11 | Issued | 2033-07-12 | 2035-07-11 |
900033 | fluticasone furoate, umeclidinium (as bromide), vilanterol (as trifenatate) | 204880 | 2781487 | 2030-11-29 | Issued | 2030-11-30 | 2032-11-29 |
900044 | galcanezumab | 219521 | 2802102 | 2031-06-07 | Issued | 2031-06-08 | 2033-06-07 |
900055 | gilteritinib fumarate | 227918 | 2760061 | 2030-05-06 | Issued | 2030-05-07 | 2032-05-06 |
900062 | glasdegib | 225793 | 2690953 | 2028-06-16 | Issued | 2028-06-17 | 2030-06-16 |
900001 | glecaprevir / pibrentasvir | 202233 | 2807847 | 2031-10-12 | Refused | N/A | N/A |
900014 | glycopyrronium (as bromide) / formoterol fumarate dihydrate | 201306 | 2763936 | 2030-05-28 | Refused | N/A | N/A |
900003 | guselkumab | 200590 | 2635692 | 2026-12-28 | Issued | 2026-12-29 | 2028-12-28 |
900085 | inclisiran sodium | 243470 | 2892160 | 2033-12-05 | Issued | 2033-12-06 | 2035-12-05 |
900090 | infigratinib phosphate | 246904 | 2781431 | 2030-12-06 | Refused | N/A | N/A |
900032 | inotersen (inotersen sodium) | 214274 | 2797792 | 2031-04-29 | Issued | 2031-04-30 | 2033-04-29 |
900023 | insulin glargine / lixisenatide | 207006 | 2740685 | 2029-10-09 | Issued | 2029-10-10 | 2031-10-09 |
900029 | lanadelumab | 213920 | 2786019 | 2031-01-06 | Issued | 2031-01-07 | 2033-01-06 |
900043 | larotrectinib (larotrectinib sulfate) | 219998 | 2741313 | 2029-10-21 | Issued | 2029-10-22 | 2031-10-21 |
900066 | lefamulin (supplied as lefamulin acetate) | 233292 | 2678795 | 2028-03-19 | Issued | 2028-03-20 | 2030-03-19 |
900069 | lemborexant | 231286 | 2811895 | 2031-09-20 | Issued | 2031-09-21 | 2033-09-20 |
900109 | lenacapavir (lenacapavir sodium) | 262999 | 3021227 | 2037-08-17 | Issued | 2037-08-18 | 2037-11-03 |
900007 | letermovir | 204165 | 2524069 | 2024-04-17 | Issued | 2024-04-18 | 2026-04-17 |
900009 | lifitegrast | 199810 | 2609053 | 2026-05-17 | Issued | 2026-05-18 | 2028-05-17 |
900040 | lorlatinib | 215733 | 2863892 | 2033-02-20 | Issued | 2033-02-21 | 2034-02-23 |
900087 | lurbinectedin | 247485 | 2455768 | 2022-08-06 | Issued | 2022-08-07 | 2024-08-06 |
900071 | luspatercept | 236441 | 2733911 | 2029-08-13 | Issued | 2029-08-14 | 2031-08-13 |
900104 | lutetium (177lu) vipivotide tetraxetan | 260951 | 2924360 | 2034-10-17 | Issued | 2034-10-18 | 2036-10-17 |
900086 | macitentan / tadalafil | 245848 | 2659770 | 2027-08-28 | Issued | 2027-08-29 | 2029-08-28 |
900111 | mavacamten | 258772 | 2915967 | 2034-06-19 | Issued | 2034-06-20 | 2036-06-19 |
900120 | mirikizumab | 266471 | 2901462 | 2034-03-04 | Pending | N/A | N/A |
900002 | neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily A / neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily B | 195550 | 2463476 | 2022-10-11 | Issued | 2022-10-12 | 2024-10-11 |
900008 | olaratumab | 203478 | 2680945 | 2026-06-19 | Issued | 2026-06-20 | 2028-06-19 |
900072 | ozanimod (ozanimod hydrochloride) | 232761 | 2723904 | 2029-05-14 | Issued | 2029-05-15 | 2031-05-14 |
900073 | ozanimod (ozanimod hydrochloride) | 232761 | 2780772 | 2030-11-15 | Withdrawn | N/A | N/A |
900091 | palovarotene | 252065 | 2809374 | 2031-08-31 | Issued | 2031-09-01 | 2033-08-31 |
900094 | pemigatinib | 242569 | 2876689 | 2033-06-12 | Issued | 2033-06-13 | 2035-06-12 |
900080 | pertuzumab, trastuzumab | 237402 | 2788253 | 2032-08-29 | Refused | N/A | N/A |
900098 | pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) conjugated to diphtheria CRM197 protein | 253111 | 2881420 | 2033-08-12 | Pending | N/A | N/A |
900092 | pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) conjugated to CRM197 protein | 247042 | 2788680 | 2031-02-03 | Issued | 2031-02-04 | 2033-02-03 |
900121 | Pneumococcal polysaccharide serotypes 1*, 3*, 4*, 5*, 6A*, 6B*, 7F*, 8*, 9V*, 10A*, 11A*, 12F*, 14*, 15B*, 18C*, 19A*, 19F*, 22F*, 23F*, and 33F*; * conjugated to diphtheria CRM197 protein | 253111 | 3170344 | 2035-01-15 | Pending | N/A | N/A |
900067 | polatuzumab vedotin | 232303 | 2693255 | 2028-07-15 | Issued | 2028-07-16 | 2030-07-15 |
900079 | ponesimod | 239537 | 2968180 | 2035-12-10 | Issued | 2035-12-11 | 2036-04-29 |
900050 | prasterone | 198822 | 2696127 | 2028-08-08 | Withdrawn | N/A | N/A |
900068 | remdesivir | 240551 | 2804840 | 2031-07-22 | Issued | 2031-07-23 | 2033-07-22 |
900016 | ribociclib (ribociclib succinate) | 203884 | 2734802 | 2029-08-20 | Issued | 2029-08-21 | 2031-08-20 |
900065 | ripretinib | 234688 | 2875970 | 2032-06-07 | Issued | 2032-06-08 | 2034-06-07 |
900042 | risankizumab | 215753 | 2816950 | 2031-11-02 | Issued | 2031-11-03 | 2033-11-02 |
900078 | risdiplam | 242373 | 2948561 | 2035-05-11 | Issued | 2035-05-12 | 2036-04-15 |
900031 | rivaroxaban | 211611 | 2451258 | 2022-06-07 | Refused | N/A | N/A |
900046 | romosozumab | 197713 | 2607197 | 2026-04-28 | Issued | 2026-04-29 | 2028-04-28 |
900061 | satralizumab | 233642 | 2699834 | 2029-09-25 | Issued | 2029-09-26 | 2031-09-25 |
900005 | semaglutide | 202059 | 2601784 | 2026-03-20 | Issued | 2026-03-21 | 2028-03-20 |
900054 | siponimod | 223225 | 2747437 | 2029-12-16 | Withdrawn | N/A | N/A |
900059 | siponimod | 223225 | 2747992 | 2029-12-21 | Issued | 2029-12-22 | 2031-12-21 |
900117 | somatrogon | 246729 | 2928269 | 2034-10-21 | Issued | 2034-10-22 | 2036-10-21 |
900112 | spesolimab | 267362 | 2852994 | 2032-11-14 | Issued | 2032-11-15 | 2034-11-14 |
900038 | suvorexant | 160233 | 2670892 | 2027-11-30 | Refused | N/A | N/A |
900107 | tafasitamab | 247025 | 2841738 | 2032-08-14 | Issued | 2032-08-15 | 2034-08-14 |
900048 | talazoparib (talazoparib tosylate) | 220584 | 2732797 | 2029-07-27 | Issued | 2029-07-28 | 2031-07-27 |
900101 | tebentafusp | 258717 | 2766505 | 2030-07-01 | Issued | 2030-07-02 | 2032-07-01 |
900082 | tepotinib hydrochloride | 242300 | 2693600 | 2028-04-29 | Issued | 2028-04-30 | 2030-04-29 |
900036 | tezacaftor / Ivacaftor | 211292 | 2742821 | 2028-11-12 | Issued | 2028-11-13 | 2030-11-12 |
900105 | tezepelumab | 256188 | 2698382 | 2028-09-09 | Issued | 2028-09-10 | 2030-09-09 |
900108 | tirzepatide | 259103 | 2973352 | 2036-01-05 | Issued | 2036-01-06 | 2037-11-25 |
900030 | tisagenlecleucel | 213547 | 2820681 | 2031-12-09 | Issued | 2031-12-10 | 2033-12-09 |
900081 | trastuzumab deruxtecan | 242104 | 2928794 | 2035-01-28 | Issued | 2035-01-29 | 2036-04-16 |
900064 | tucatinib | 235295 | 2632194 | 2026-11-15 | Issued | 2026-11-16 | 2028-11-15 |
900049 | upadacitinib | 223734 | 2781891 | 2030-12-01 | Issued | 2030-12-02 | 2032-12-01 |
900006 | varicella-zoster virus glycoprotein E (gE) | 200244 | 2600905 | 2026-03-01 | Refused | N/A | N/A |
900116 | vericiguat | 240862 | 2800697 | 2031-05-24 | Issued | 2031-05-25 | 2033-05-24 |
900075 | zanubrutinib | 242748 | 2902686 | 2034-04-22 | Issued | 2034-04-23 | 2036-03-02 |
Certificate of Supplementary Protection (CSP) and/or Application Number |
Medicinal Ingredient(s) | New Drug Submission (NDS) Number | Patent Number | Patent Expiry Date yyyy-mm-dd |
Application Status | CSP Term Begins yyyy-mm-dd |
CSP Term Ends yyyy-mm-dd |
---|---|---|---|---|---|---|---|
900083 | ciclesonide | 200882 | 2888428 | 2033-12-18 | Issued | 2033-12-19 | 2035-05-01 |
900077 | esafoxolaner / eprinomectin / praziquantel | 234676 | 2848317 | 2032-09-12 | Refused | N/A | N/A |
900013 | lotilaner | 193712 | 2747354 | 2029-12-17 | Issued | 2029-12-18 | 2031-12-17 |
900047 | sarolaner / moxidectin / pyrantel (as pyrantel pamoate) | 210868 | 2882200 | 2033-09-04 | Issued | 2033-09-05 | 2034-09-27 |
900037 | sarolaner / selamectin | 190913 | 2828397 | 2032-02-23 | Issued | 2032-02-24 | 2033-11-07 |
Background
The Register of Certificates of Supplementary Protection (CSP) and Applications is maintained pursuant to the Certificate of Supplementary Protection Regulations and the Patent Act. The register includes information from CSPs and CSP applications. Under the subsection 115(1) of the Patent Act, the issuance of a CSP grants the certificate's holder and their legal representatives the same legal rights, privileges and liberties that are granted by the patent set out in the certificate, but only with respect to the making, constructing, using and selling of any drug that contains the medicinal ingredient, or combination of medicinal ingredients.
The format of the register is an electronic table. The register lists, in alphabetical order, the medicinal ingredient(s) in the CSPs and CSP applications.
Information regarding the patent set out in the CSP or CSP application is available at the Canadian Intellectual Property Office.
For comments or questions, or to obtain a copy of a CSP or CSP application details, please contact the Office of Patented Medicines and Liaison by email at hc.opml-bmbl.sc@canada.ca or by telephone at 613-941-7281.
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