Drug firm Glenmark today said it has signed an exclusive licensing agreement with the US-based Par Pharmaceutical to sell generic cholesterol-lowering drug Ezetimibe in the US market.
Ezetimibe is a generic version of Merck-Schering Plough's patented drug Zetia and Glenmark is currently fighting a patent litigation in the US over the drug. Glenmark claims that it has first-to-file status on Ezetimibe tablets, thereby providing a potential of 180-days of marketing exclusivity in the US market.
"Under the agreement, Glenmark has received a payment from Par for acquiring exclusive rights to market, sell and distribute the product in the US," Glenmark said in a statement here today. The company, however, did not disclose the sum citing confidentiality clause.
"The companies will share the profits from the sales of the product," Glenmark said, adding Zetia has annual sales of around $1.4 billion in the US, quoting IMS Health Data. Moreover, it said Par will also share the cost of the ongoing litigation in Ezetimibe is a New Jersey district court.
Merck's patent for Zetia expires in 2016, but the company bagged a re-issued patent during 2002-03. The Mumbai-based firm had got the tentative approval for the drug last year through its US-based subsidiary Glenmark Generics for Ezetimibe tablets in 10mg strength.
Glenmark had filed an abbreviated new drug application (ANDA) with the US food and drug administration seeking regulatory approval on October 25, 2006.
