Voluntary compliance undertaking of Glaxosmithkline Inc. to the Patented Medicine Prices Review Board

1.0 Product Summary

1.1. Clindoxyl Gel (clindamycin/benzoyl peroxide) is indicated for the topical treatment of moderate acne vulgaris characterized by the presence of comedones, papules and pustules.

1.2. Health Canada first issued a Notice of Compliance for Clindoxyl Gel 10/50 – 60 mg/gram (DIN 02243158) on December 11, 2000. Clindoxyl Gel was first sold in Canada on July 1, 2001.

1.3. The first reported patent pertaining to Clindoxyl Gel was granted on October 14, 1997, and the last reported patent is set to expire on January 23, 2024. GlaxoSmithKline Inc. (“GSK”) is the rights holder for the purposes of the Patent Act and the Patented Medicine Prices Review Board (PMPRB).

2.0 Application of the Guidelines

2.1 The National Average Transaction Price (N-ATP) of Clindoxyl Gel exceeded its Non-Excessive Average Price (NEAP) in 2021, triggering the investigation criteria set out in the Guidelines based on excess revenues generated. As of December 31, 2022, the cumulative excess revenues were determined to be $571,128.77.

3.0 Position of the Rights Holder

3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by GSK that the prices of Clindoxyl Gel are now, or were at any time since the date of first sale, excessive for the purposes of the Patent Act, nor is this VCU binding upon any panel of the Board for the purposes of the Patent Act.

4.0 Terms of the Voluntary Compliance Undertaking

4.1 Pursuant to this VCU, GSK will undertake:

4.1.1 To reduce the list price of Clindoxyl Gel to $0.7500 effective May 8, 2023;

4.1.2 To offset the excess revenues of $571,128.77 by January 23, 2024;

4.1.3 To make a further payment to His Majesty in right of Canada within 30 days of receiving PMPRB Staff’s notification of any remaining cumulative excess revenues as of
June 30, 2024, as calculated based on the January to June 2024 price and sales data filed by GSK;

4.1.4 To ensure that the price of Clindoxyl Gel remains within the PMPRB’s Guidelines in all future periods in which it is under the PMPRB’s jurisdiction.


Name: Sridhar Venkatesh
Position: VP – General Manager
Rights Holder: GlaxoSmithKline Inc.
Date: August 28, 2023

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