Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics Ltd (GGL), has been granted tentative approval by the United States Food and Drug Administration (US FDA) for trandolapril and verapamil hydrochloride extended-release tablets, its generic version of Abbott’s Tarka tablets.
Glenmark believes that as of date it has first-to-file status on trandolapril and verapamil hydrochloride extended-release tablets, which provides Glenmark the potential of 180 days of generic marketing exclusivity. Glenmark therefore would have the first opportunity among all potential generic competitors to market a generic equivalent to Tarka, which achieved sales of USD 64 million for the 12-month period ending September 2009(Source : IMS). Product launch is dependent upon receipt of final approval of Glenmark's ANDA from the US FDA and resolution of litigation currently pending in the US District Court for the District of New Jersey.
In a statement from Glenmark Generics Ltd’s chief executive officer, Terrance Coughlin commented, “Today’s announcement is an important step in the evolution of Glenmark in the United States. 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. We will continue to rely on the strength of our portfolio and the expertise of our scientists in India to sustain a significant place in this market.”
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 US FDA. The company remains focused on strategic planning and development and continues its aggressive filing schedule for new ANDA submissions.