India Inc:
Indian pharmaceutical firm Dr Reddy’s Laboratories has launched Clopidogrel tablets in the US market with a 180-day exclusivity clause. The tablets are a bioequivalent generic version of blood thinner drug Plavix, sold by Bristol Myers Squibb and Sanofi SA.
The Hyderabad-based company was among the first applicants to submit an Abbreviated New Drug Application (ANDA) for Clopidogrel tablets in the 300-mg capacity, the company said.
The product in 75-mg strength is available in bottle count sizes of 30, 90 and 500 while the 300-mg strength drug is available in blister packs of 30, it added.
Clopidogrel tablets fall under the cardio-vascular therapeutic segment and is recommended for the prevention of various heart ailments, including peripheral arterial disease.
The Plavix brand had US sales of approximately $6.740 billion over the last fiscal year.
The launch of generic Plavix marks the beginning of the drug-maker’s big plans for the US market.
Dr Reddy’s has 80 ANDAs pending with the US Food and Drug Administration (FDA) for approval. Of these, seven have first-to-file status, which will enable the company to exclusively market generic versions for 180 days.
Dr Reddy’s launched 12 products and sought the US FDA’s approvals for 17 generic drugs in the US in 2011-12.
