Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clopidogrel Tablets USP, 75 mg and 300 mg. 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 this strength. This product 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.
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 U.S. sales of approximately $6.7 billion for the 12 months ending March 31, 2012, according to IMS Health.
Currently, Mylan has 173 ANDAs pending FDA approval representing $98.2 billion in annual sales, according to IMS Health. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing $25.5 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.