Mylan Inc. has confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 and 10/80 mg. This product is the generic version of Caduet Tablets, which combine the long-acting calcium channel blocker amlodipine besylate with the synthetic lipid-lowering agent atorvastatin calcium.
Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the 2.5/10 mg, 2.5/20 mg, 2.5/40 mg and 10/40 mg strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. Pfizer filed the lawsuit in the U.S. District Court for the District of Delaware.
Caduet Tablets had approximately $65.6 million in sales for the 2.5/10 mg, 2.5/20 mg, 2.5/40 mg and 10/40 mg strengths for the twelve months ending Dec. 31, 2009, according to IMS Health. Currently, Mylan has 142 ANDAs pending FDA approval representing $87.5 billion in annual brand sales, according to IMS. Forty of these pending ANDAs are potential first-to-file opportunities, representing $19.6 billion in annual brand sales, according to IMS.