Breckenridge Pharmaceutical Announces Settlement of Actos® (Pioglitazone Hydrochloride) Patent Litigation

BOCA RATON, Fla., May 16, 2011 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced that Breckenridge and Synthon Pharmaceuticals, Inc. have reached an agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America resolving patent litigation related to Pioglitazone Hydrochloride 15 mg, 30 mg and 45 mg tablets, a generic equivalent version of Actos®. Under the terms of the agreement, Takeda granted Breckenridge and Synthon a non-exclusive, royalty-free license to its U.S. patents covering Actos®, permitting launch of their generic-equivalent formulation of Actos® after first-filers of ANDAs with paragraph IV certifications exhaust their 180-day marketing exclusivity on February 13, 2013, or earlier under certain circumstances, subject to regulatory approval.

Breckenridge and Synthon signed a distribution and supply agreement on the product in late 2009 and have been working together on this product, including the settlement of the paragraph IV litigation.

Actos® had approximately $3.4 billion in brand sales for the twelve months ending December 31, 2009, according to IMS Health. Actos® is a once-daily oral prescription medication that, with diet and exercise, has been shown to be effective for the treatment of type 2 diabetes.

* 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.

www.bpirx.com

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.

www.synthon.com

SOURCE Breckenridge Pharmaceutical, Inc.

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