Dr Reddy`s Labs, Mylan launch generic version of Plavix tablet
Mumbai: Pharma major Dr Reddy`s Laboratories and Nasdaq-listed Mylan Inc in Friday announced launching of Clopidogrel tablets, USP, a bioequivalent generic version of blood thinning drug, Plavix in the US market.
The Plavix brand was among the best-selling drugs in history had US sales of approximately USD 6.7 billion for the 12 months ending March 31, 2012, according to IMS Health.
Plavix`s US patent expired yesterday, clearing the way for generic versions of the drug.
Clopidogrel is the generic version of Sanofi-Aventis` Plavix, and is indicated for acute coronary syndrome and for patients with a recent history of myocardial infarction, stroke or established peripheral arterial disease.
The ANDAs for clopidogrel tablets USP, 75 mg & 300 mg are approved by the United States Food & Drug Administration (USFDA), Dr Reddy`s Lab said in a statement here.
An Abbreviated New Drug Application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug.
The Hyderabad-based Indian pharma firm was among the first applicants to submit a substantially complete ANDA for Clopidogrel tablets USP, 300 mg with a Paragraph IV certification, and was awarded 180 days of marketing exclusivity for this strength.
Mylan Pharmaceuticals Inc has also received final nod from the US Food and Drug Administration (USFDA) for its ANDA for Clopidogrel tablets, the release issued by the company said.
Mylan Pharmaceuticals will provide customers with the 75 mg strength of this product in bottle form, and Mylan Institutional, which serves the institutional pharmaceutical market, will supply the 300 mg strength exclusively in unit dose packs of 30. This business also will supply Clopidogrel tablets, 75 mg, in unit dose packs of 100. Mylan is shipping all product presentations immediately.
Aurobindo Pharma and Sun Pharma have also received USFDA`s approval for the Clopidogrel tablets in 75 mg strength.