Nasdaq listed-Mylan Inc on Friday announced that its subsidiary Mylan Pharmaceuticals Inc has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clopidogrel tablets.
The company was the first to have filed a substantially complete ANDA containing a Paragraph IV certification to the FDA for Clopidogrel tablets, 300 mg, and was awarded 180 days of marketing exclusivity for its strength, a company statement said here.
The product is a 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 release 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.
Plavix Tablets, 75 mg and 300 mg, had US sales of approximately USD 6.7 billion for the 12 months ending March 31, 2012, according to IMS Health.
Currently, Mylan has 173 ANDAs pending FDA approval representing USD 98.2 billion in annual sales, according to IMS Health. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing USD 25.5 billion in annual brand sales, for the 12 months ending December 31, 2011, according to IMS Health.