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