Alembic Pharmaceuticals, along with Breckenridge Pharmaceuticals Inc., USA, has settled Paragraph IV patent litigation with Novartis concerning rivastigmine tartrate capsules, a generic version of Exelon by Novartis. Both companies will launch product immediately.
Alembic 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 US Patent on February 11, 2014.
Rivastigmine tartrate capsules is a prescription medicine that is indicated for the treatment of mild to moderate dementia of Alzheimer's type, and for the treatment of mild to moderate dementia associated with Parkinson's disease. The current generic market is approximately $46 million, based on industry sales data. The product will be available in 4 strengths viz. 1.5 mg, 3, mg, 4.5 mg and 6 mg.
Breckenridge is a privately-held pharma marketing, research and development company founded in 1983 that markets a broad range of generic prescription products in many therapeutic categories. The company markets over 70 products in a variety of dosage forms.