Glenmark sees 180-day exclusive sales potential for trandolapril and verapamil (Tarka) generic

Glenmark Generics Inc has been granted tentative approval for its generic trandolapril and verapamil hydrochloride extended-release tablets from the US FDA.

Glenmark’s trandolapril and verapamil hydrochloride extended-release tablets is the generic version of Abbott’s Tarka tablets.

Tarka tablets achieved sales of USD 64 million for the 12-month period ending September 2009, according to IMS.

Glenmark may get final approval for generic trandolapril and verapamil ANDA from the U.S. FDA after resolving of the litigation currently pending in the US District Court for the District of New Jersey.

Glenmark expects the potential of 180 days of generic marketing exclusivity for trandolapril and verapamil hydrochloride extended-release tablets as the company believes that as of date it has first-to-file status.

The first-to-file status would provide Glenmark the first opportunity among all potential generic competitors to market a generic equivalent to Tarka, the company said in an official release.

“In 2010 fiscal year to date, we have received 6 tentative approvals and 6 final approvals from the FDA. Today’s tentative approval is the third granted to Glenmark within a one month time frame,” Glenmark Generics Ltd’s Chief Executive Officer, Mr. Terrance Coughlin commented.

In September, Glenmark Generics received approvals for its abbreviated new drug application (ANDA) for verapamil 240mg
strength extended release tablets from US FDA.

Glenmark’s verapamil 240mg  extended release tablet is the generic equivalent of Knoll Pharma’s Isoptin SR tablets.

Verapamil, a calcium channel blocker used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders, is also sold under the brand names Calan, Calan SR, Covera-HS, Verelan, Verelan PM.

Verapamil SR on 240 mg strength has more than half the market share of the overall Verapamil SR product line. Total sales for the twelve month period ending June 2009 was USD 65 million, as per IMS Health.

Glenmark’s current marketing portfolio consists of 49 products authorized for distribution in the United States and it has nearly 50 ANDAs in various stages of the approval process with the U.S. FDA.

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark).

Glenmark Generics has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries. The company primarily sells its FDF products in the United States and the European Union, as well as its oncology FDF products in South America. Glenmark Generics supplies APIs to customers in approximately 65 countries, including the US, various countries in the EU, South America and India. Headquartered at Mumbai, India, has twelve manufacturing facilities in four countries and has five R&D centres.