Breckenridge Announces Approval for Pioglitazone Hydrochloride tablets

    Breckenridge Announces Approval for Pioglitazone Hydrochloride tablets

PR Newswire

BOCA RATON, Fla., Feb. 13, 2013

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.

Contact: Larry Lapila, Executive Vice President, Breckenridge Pharmaceutical,
Inc., +1-860-828-8140, FAX: +1-860-828-8142,; Fabienne
Douven, Senior Corporate Communications Manager, Synthon Pharmaceuticals,
Inc., +31 24 3727759, FAX: +31 24 3727711,
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