Breckenridge and Alembic Announce Settlement with Novartis of PIV litigation on Rivastigmine Tartrate Capsules
BOCA RATON, Fla., June 14, 2012 /PRNewswire/ – Breckenridge Pharmaceutical, Inc. announced today that Breckenridge and Alembic Pharmaceuticals Limited have settled their Paragraph IV patent litigation with Novartis concerning Rivastigmine Tartrate Capsules, a generic version of Exelon® by Novartis, and that the U.S. Food and Drug Administration (FDA) approved their Abbreviated New Drug Application (ANDA). The companies will launch immediately. Alembic Pharmaceuticals Limited is the sponsor and manufacturer of the ANDA, which will be marketed exclusively by Breckenridge. Under the terms of the settlement agreement, Novartis has granted Breckenridge and Alembic a license to market a generic version of Exelon® before the expiration of U.S. Patent No. 5,602,176, on February 11, 2014.
Rivastigmine Tartrate Capsules is a prescription medicine that is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type, and for the treatment of mild to moderate dementia associated with Parkinson’s disease. The current generic market is approximately $46M, based on industry sales data. The product will be available in 4 strengths: 1.5mg, 3mg, 4.5mg & 6mg.
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.