Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval For Desvenlafaxine XR Tablets (Pristiq)

BOCA RATON, Fla., July 1, 2015 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that Breckenridge and Alembic Pharmaceuticals Limited were granted final approval for their ANDA desvenlafaxine succinate extended-release tablets 50mg and 100mg, a generic version of Pristiq® by Pfizer Inc.  Breckenridge and Alembic filed their Paragraph IV ANDA on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers.  Alembic Pharmaceuticals Limited is the sponsor and manufacturer of the ANDA, which will be marketed exclusively by Breckenridge. The Paragraph IV litigation with respect to the ANDA has been settled on terms that are confidential.  The settlement includes a license effective prior to the expirations of the patents involved in the litigation. Further announcements will be made prior to product launch.

Desvenlafaxine is a prescription drug that is indicated for the treatment of major depressive disorder.  Desvenlafaxine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs).  Pristiq® generated sales of $742 million, based on May 2015 IMS Health Sales Data.  The product will be available in 50mg and 100mg tablets.

Breckenridge's latest patent challenge for desvenlafaxine succinate extended-release tablets 50mg and 100mg highlights its aggressive Paragraph IV strategy.  Breckenridge currently has twenty-two (22) 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 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

PRISTIQ® is a trademark of Pfizer, Inc. or its affiliates.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/breckenridge-pharmaceutical-inc-announces-final-anda-approval-for-desvenlafaxine-xr-tablets--pristiq-300107873.html

SOURCE Breckenridge Pharmaceutical, Inc.

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