Breckenridge and Alembic Announce Paragraph IV ANDA Litigation with Pfizer on Desvenlafaxine tablets (Pristiq®)
BOCA RATON, Fla., June 27, 2012 /PRNewswire/ — Breckenridge Pharmaceutical, Inc. announced today that Breckenridge and Alembic Pharmaceuticals Limited were named codefendants in a Paragraph IV lawsuit filed by Pfizer Inc. concerning 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-possible submission date and expects 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.
Desvenlafaxine is a prescription drug that is indicated for the treatment of depression. Desvenlafaxine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). Pristiq® generated sales of $577 million in 2011, based on industry sales data, with eventual projected sales of $1 billion annually. The product will be available in 50mg and 100mg tablets.
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
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 all over the world including the US FDA. Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a field force of over 3000 sales representatives, are well recognized by doctors and patients. More information about the company can be found at www.alembic-india.com; (Reuters: ALEM.NS, Bloomberg: ALPM: IN, NSE: APLLTD, BSE: 533573)
SOURCE Breckenridge Pharmaceutical, Inc.