Glenmark confirms patent challenge on Atovaquone & Proguanil Hydrochloride tablets

Glenmark Generics confirmed that Smithkline Beecham Corporation (d/b/a Glaxosmithkline) filed patent infringement lawsuit on their US subsidiary, Glenmark Generics Inc, USA (Glenmark) in the US District Court for the District of Delaware in connection with the abbreviated new drug application (ANDA) filing for Atovaquone and Proguanil Hydrochloride 250mg/100mg tablets.

GSK currently markets their product as Malarone in the United States and is indicated for the prevention and treatment of malaria.

Total US sales as reported by IMS Health for the 12 months period ending June 2009 were approximately $53 million.

Glenmark believes it is the sole first to file applicant on this product. Glenmark had earlier filed its ANDA containing a paragraph IV certification for its generic version of atovaquone and proguanil hydrochloride tablets with US Food and Drug Administration (USFDA), and the following receipt of the notice from the USFDA that Glenmarks’s ANDA had been accepted for filing notified the New Drug Application (NDA) holder and patent owner.

Smithkline Beecham Corporation’s lawsuit is part of the patent challenge process under the Hatch-Waxman Act. In the event that Glenmark successfully challenges the patent, it will be entitled to sole marketing exclusivity for the 180 days period.

Glenmarks’s current portfolio consists of over 40 products authorised for distribution in the US marketplace. The company has 45 ANDA’s pending for approval with the USFDA.