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Breckenridge Announces Approval for Pioglitazone Hydrochloride tablets

BOCA RATON, Fla., Feb. 13, 2013 /PRNewswire/ -- 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.  * Actos® is a registered trademark of Takeda Chemical Industries, Ltd.

About Breckenridge:
Breckenridge Pharmaceutical, Inc. is a privately-held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of generic prescription products in many therapeutic categories.  The Breckenridge label is recognized by Wholesalers, Distributors, Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide.  The company markets over 70 products in a variety of dosage forms including:  Tablets, Capsules, Soft Gel Capsules, Liquids, Suspensions, and Powders.  

About Synthon:
Synthon Pharmaceuticals, Inc., with its U.S. headquarters and laboratories located in Research Triangle Park, North Carolina, markets generic drugs through partnerships with other leading pharmaceutical companies. Synthon currently holds several approved, or tentatively approved, drug applications and has a pipeline containing more than a dozen products that are expected to be filed with the FDA within the next few years. Synthon Pharmaceuticals, Inc. is part of the Synthon group, a global privately held specialty pharma company with offices, laboratories and manufacturing sites in 11 countries worldwide.

SOURCE Breckenridge Pharmaceutical, Inc.
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