FDA grants final approval to Breckenridge’s Pioglitazone Hydrochloride ANDA

Feb 14 2013

Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Pioglitazone Hydrochloride Tablets. The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA), which is being manufactured and supplied by Synthon Pharmaceuticals, Inc., and will be available in 15 mg, 30 mg, and 45 mg strengths. 

Breckenridge is launching its ANDA prior to patent expiration pursuant to a settlement of Paragraph IV patent litigation with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America, Inc., who granted Breckenridge and Synthon a license to applicable patents to sell and distribute its ANDA.  Pioglitazone Hydrochloride is AB rated to Actos® a once-daily oral prescription medication that, with diet and exercise, has been shown to be effective for the treatment of type 2 diabetes, and is marketed by Takeda Pharmaceutical. According to industry data, Actos® had approximately $3.7 billion in brand sales for the twelve months ending August 2012, prior to generic competition.