Voluntary Compliance Undertaking of Actavis Specialty Pharmaceutical Co. to the Patented Medicine Prices Review Board

1.0 Product Summary

1.1. Gelnique 100 mg/gram (oxybutynin chloride) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

1.2. Canadian Patent 2504021 pertaining to Gelnique was granted to Watson Pharmaceuticals Inc. (United States) on August 13, 2013, and will expire on October 31, 2023.

1.3. Health Canada issued a Notice of Compliance (NOC) for Gelnique on April 15, 2011. Sales in Canada commenced October 27, 2011.

1.4. Actavis Specialty Pharmaceutical Co. is the patentee for purposes of the Patent Act and the Patented Medicines Prices Review Board (PMPRB).

2.0 Application of the Excessive Price Guidelines

2.1 The Human Drug Advisory Panel recommended Gelnique be reviewed as a Slight/No improvement and identified Oxytrol 36 mg/patch as the most appropriate comparator.

2.2 In accordance with the Guidelines, a Therapeutic Class Comparison (TCC) test and an International Price Comparison (IPC) test were conducted. The results of these tests indicated that the October to December 2011 introductory price exceeded the Guidelines at a level that triggered the investigation criteria. In particular, the National Average Transaction Price (N-ATP) was 55.2% above the Maximum Average Potential Price (MAPP) resulting in excess revenues of $29.87. Cumulative excess revenues were $573,648.09 as of June 30, 2014.

2.3 The N-ATP and the Market Specific ATPs (MS-ATPs) were above their respective Non-Excessive Average Prices (NEAPs) in 2011. In the January to December 2012, January to December 2013 and January to June 2014 reporting periods, the MS ATPs exceeded their respective NEAPs in all markets where Gelnique was sold.

3.0 Position of Patentee

3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Actavis Specialty Pharmaceutical Co. that the price of Gelnique is or was excessive for purposes of the Patent Act.

4.0 Terms of the Voluntary Compliance Undertaking

In order to comply with the Guidelines, Actavis Specialty Pharmaceutical Co. agrees to undertake the following:

4.1 To agree that the MAPP and N-NEAPs for Gelnique are as follows: 

2011  $1.8043
2012  $1.8314
2013  $1.8494
2014  $1.8927
2015  $1.9192

4.2 To reduce the N-ATP of Gelnique in 2015 to the 2015 N-NEAP as stated in 4.1 above and ensure that the price in each market where Gelnique is sold is within the Guidelines;

4.3 To offset cumulative excess revenues received by Actavis Specialty Pharmaceutical Co. as of June 30, 2014, by making a payment to Her Majesty in right of Canada in the amount of $573,648.09 within 30 days of the acceptance of this VCU;

4.4 To offset any additional excess revenues received from July 1, 2014, to the date of implementation of this VCU, as calculated by Board Staff, within 30 days of the filing of the July to December 2014 price and sales data;

4.5 To ensure that the price of Gelnique remains within the Guidelines in all future periods in which Gelnique is under the PMPRB’s jurisdiction.

Signature:

Name:

Position:

Patentee: Actavis Specialty Pharmaceutical Co.

Date: