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Back To News: Final Approval for Megace ES generic version granted
Final Approval for Megace ES generic version granted
[Dec 04, 2017]

FOR IMMEDIATE RELEASE                                                  



December 4, 2017


Breckenridge Pharmaceutical, Inc. Announces Final Approval of its ANDA Megestrol Acetate Oral Suspension (Megace® ES)


Boca Raton, Florida, December 4, 2017 - Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration granted final approval for its Abbreviated New Drug Application for Megestrol Acetate Oral Suspension, a generic version of Megace®ES by Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc.  Breckenridge previously was engaged in Paragraph IV litigation with Par Pharmaceutical, Inc and Alkermes Pharma Ireland Limited, which was resolved allowing Breckenridge to launch its ANDA upon approval.  The company will launch immediately. 


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 combined annual sales of $17.6 Million, according to October 2017 IMS Health sales data.


Breckenridge’s patent challenge for megestrol acetate oral suspension highlights its aggressive Paragraph IV strategy.  Breckenridge currently has twenty-four (24) ANDAs filed and pending with FDA that contain Paragraph IV patent challenges, and intends to continue that trend in the next several years, focusing on niche and first-to-file Paragraph IV opportunities with certain barriers to entry. 


About Breckenridge:

Breckenridge Pharmaceutical, Inc. is a privately-held own-label distributor that performs pharmaceutical marketing, research and development, as well as marketing and distribution in the U.S. The company was founded in 1983 and 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, ophthalmics, nasal sprays, powders and injectable products.

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