Breckenridge Pharmaceutical, Inc. Announces Launch
of Desvenlafaxine XR Tablets (generic for Pristiq®)
Boca Raton, Florida, March 1, 2017 - Breckenridge Pharmaceutical, Inc. announced today the launch of desvenlafaxine succinate extended-release tablets 50mg and 100mg, a generic version of Pristiq® by Pfizer Inc. The ANDA was filed as a Paragraph IV on the first-to-file date and will share 180-day exclusivity with other ANDA first filers. Alembic Pharmaceuticals Limited is the manufacturer of the ANDA, which will be marketed exclusively by Breckenridge. The Paragraph IV litigation was settled on terms that are confidential.
Desvenlafaxine is a prescription drug that is indicated for the treatment of major depressive disorder, and is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). Pristiq® generated sales of $883 million, based on December, 2016 IMS Health Sales Data.
Breckenridge’s litigation involving desvenlafaxine succinate extended-release tablets 50mg and 100mg highlights its aggressive Paragraph IV strategy. Breckenridge currently has twenty-seven (27) 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.
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 and powders. www.bpirx.com
About Alembic Pharmaceuticals Limited:
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the US FDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients. Information about the company can be found at www.alembic-india.com; (reuters:ALEM.NS) (bloomberg:ALPM) (nse:APLLTD) (bse:533573)
For Further Information, please contact:
Breckenridge Pharmaceutical, Inc.
Brian Guy, Vice President – Business Development
Eugene Kim, Senior Vice President-Corporate Strategy/General Counsel
PRISTIQ® is a trademark of Pfizer, Inc. or its affiliates.