Breckenridge Announces Paragraph IV ANDA Litigation with Par Pharmaceutical &
Alkermes Pharma Ireland Limited for its ANDA Megestrol Acetate Oral Suspension
BOCA RATON, Fla., June 28, 2013
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.
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
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, firstname.lastname@example.org;
Eugene Kim, Vice President-Corporate Strategy/General Counsel, 646-448-1302,
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