Glenmark receives first-to-file status for Zetia, Tarka, Cutivate drugs in US

Glenmark Pharmaceuticals has received first-to-file status for three of its new drugs applications (ANDA) that have a combined revenue of more than 2 billion USD, The Economic Times has reported.The company has got first-to-file status for Zetia, with the generic name Ezetimibe, Tarka (Trandolapril + Verapamil) and Cutivate (Fluticasone lotion).

With this the company gets a 180 days of head start since the Food and Drug Administration may not approve another ANDA for such a generic product after the approval.

During this period, the company can garner huge profits since they will not face any competition for half a year and the generic version will be sold at 70-80% of the branded product price.

Although litigations are at various stages for all the three products but if Glenmark wins, the company will gain an edge over the market in the six months exclusivity time, which is much sought out for.

The drug major also gets approval for their new drug for migraine, Topiramate tablets, from US Food and Drug Administration’s (USFDA).

According to NDC health, Topiramate tablets, an anti-epileptic drug which falls in the central nervous system (CNS) segments, are pegged at $1.85 billion in 2006.

Glenmark also received the approval for its abbreviated new drug applications (ANDAS) for terbinafine hydrochloride tablets of 250 mg base, the company said to the Bombay stock exchange.

As per IMS-2006 Terbinafine hydrochloride garnered annual sales of more than $650 million in the US. The drug is an AB-rated generic equivalent of Novartis’s anti-fungal lamisil tablets.

Glenmarks USFDA approved manufacturing unit in Goa will start manufacturing the finished dose formulation for Topiramate tablets and Terbinafine hydrochloride. The company’s U.S based subsidiary Glenmark Pharmaceuticals Inc will market the finished product in the US.