Voluntary Compliance Undertakings

A Voluntary Compliance Undertaking (VCU) is a written commitment by a patentee to comply with the Board’s Guidelines, including adjusting the price of the patented drug in question to a non-excessive level and offsetting any excess revenues that may have been received as the result of having sold the patented drug at an excessive price in Canada. Patentees are given the opportunity to submit a VCU when Board Staff concludes, following an investigation, that the price of a patented drug product sold in Canada appears to have exceeded the Guidelines. A VCU can also be submitted following the issuance of a Notice of Hearing, but must then be approved by the Hearing Panel. VCUs represent a compromise between the PMPRB and the patentee as a result of negotiations between the parties geared towards a satisfactory resolution of an investigation initiated by Board Staff as per the Guidelines. VCUs take into account the specific facts and underlying context of a particular case. As such, VCUs are not intended to have precedential value.

The PMPRB publishes VCUs on the web (below) once they are approved by the Chairperson of the Board or by the Hearing Panel, as the case may be. As soon as a patentee has been informed that the terms of a VCU have been accepted, the document becomes public and is reported in the PMPRB quarterly NEWSletter and the Annual Report.

Summaries of Voluntary Compliance Undertakings (VCUs) by year

Alphabetical list

A

Abilify (February 2011)

Actimmune (May 2016)

Adenoscan (May 2010)

Airomir (April 2013)

Airomir (May 2007)

Anaprox (August 1999)

Andriol (September 2009)

Androgel (June 2008)

Angiomax (March 2016)

Apprilon (February 2016)

Aromasin (April 2003)

Avonex PS (July 2012)

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B

Banzel (November 2012)

Brevibloc (September 2009)

Busulfex (November 2004)

Busulfex (June 2010)

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C

Carnitor IV (October 2015)

Ceretec (July 2005)

Cialis (May 2016)

Claritin (October 2009)

Concerta (April 2009)

Copaxone (February 2014)

Crixivan (April 2015)

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D

Denavir (April 2008)

Dicetel (May 2010)

Differin Pledget (September 2002)

Dificid (November 2015)

Diflucan (May 2012)

Dostinex (October 2003)

Dovobet (December 2007)

Dovobet (January 2012)

Dukoral (December 2005)

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E

Effient (October 2011)

Eligard (March 2009)

Elocom (July 2013)

Eloxatin (June 2006)

Evra (February 2005)

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F

FASLODEX (October 2010)

Fasturtec (June 2004)

Fibristal (June 2016)

FSME-IMMUN (March 2010)

Forteo (June 2007)

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G

Gonal F (June 2014)

Gelnique (November 2014)

GlaxoSmithKline Inc. (February 2017)

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H

Habitrol (October 1994)

Halaven (December 2012)

Hextend (July 2006)

Humalog (April 1998)

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I

Ifex (December 2012)

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L

Lamisil® (June 2014)

Lantus (March 2008)

Levemir (May 2010)

Lodalis (September 2014)

Loprox (October 2015)

Lyrica (November 2012)

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M

Mavik (April 2013)

Miochol-E (September 2010)

Mitosol (January 2016)

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N

Nasonex (October 2011)

Neoral (February 2016)

Neulasta (October 2009)

Niaspan (May 2011)

Novolin (April 2013)

Nuvaring™ (June 2006)

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O

Octreoscan (September 2007)

Oncaspar (December 2016)

One-Alpha (May 2004)

Orgalutran (October 2011)

Ortho 7/7/7 (September 2005)

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P

Pariet (May 2012)

Paxil CR (March 2010)

Paxil CR (March 2005)

Pergoveris (December 2016)

Plavix (June 2000)

Precedex (March 2012)

Procytox (December 2012)

Prolastin (July 2004)

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R

Remicade ( March 31, 2003)

Risperdal (December 2005)

Risperdal Consta (June 2007)

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S

Samsca (April 2016)

Sinemet CR (July 2011)

Spiriva Respimat (May 2016)

Starlix (July 2005)

Starnoc (July 2004)

Strattera (February 2009)

Suprane (April 2011)

Suprax (March 2009)

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T

Tactuo (April 2013)

Tamiflu (March 2005)

Tasigna (October 2010)

Technescan MAG3 (May 2011)

Thalomid (January 2012)

Trileptal (May 2012)

Trinipatch (November 2009)

Trinipatch (May 2011)

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U

Uromitexan (December 2012)

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V

Vancocin (July 2010)

Vaniqa (February 2008)

Vepesid (February 2009)

Voluven (February 2010)

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X

Xalkori (June 2016)

Xarelto (January 2010)

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Z

Zanaflex (October 2001)

Zaxine (December 2015)

Zemplar (September 2007)

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