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Breckenridge Announces Paragraph IV ANDA Litigation with Par Pharmaceutical & Alkermes Pharma Ireland Limited for its ANDA Megestrol Acetate Oral Suspension (Megace® ES)


BOCA RATON, Fla., June 28, 2013 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has filed an ANDA with a Paragraph IV certification for Megestrol Acetate Oral Suspension, a generic version of Megace® ES by Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc.  On June 21, 2013, Par Pharmaceutical, Inc. and Alkermes Pharma Ireland Limited filed a Paragraph IV lawsuit against Breckenridge concerning this ANDA in the United States District Court for the District of Delaware.

Megace® ES (megestrol acetate) is a concentrated suspension indicated for the treatment of anorexia (loss of appetite), cachexia (severe malnutrition), or an unexplained, significant weight loss in people with a diagnosis of AIDS. Megace® ES generated sales of $81M, based on industry sales data.  

Breckenridge's latest patent challenge regarding megestrol acetate is a continuing part of its larger aggressive Paragraph IV strategy commenced a few years ago.   Since the beginning of 2011, Breckenridge has filed twelve (12) Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche Paragraph IV opportunities with certain barriers to entry.

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.

Megace® is a registered trademark of Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.

SOURCE  Breckenridge Pharmaceutical, Inc.

CONTACT: Larry Lapila, Executive Vice President, 860-828-8140,; Eugene Kim, Vice President-Corporate Strategy/General Counsel, 646-448-1302,

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Information in this article was accurate in June 28, 2013. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.