Alembic Pharmaceuticals and Breckenridge Pharmaceutical Inc, USA have settled their Paragraph IV patent litigation with Novartis concerning Rivastigmine Tartrate Capsules, a generic version of Exelon by Novartis, and that the US Food and Drug Administration (USFDA) approved their abbreviated new drug application (ANDA). With this, the companies will launch product immediately.
Alembic Pharmaceuticals 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 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.
Alembic Pharmaceuticals (APL) was incorporated in June 2010 after the demerger of core pharmaceutical business of erstwhile Alembic, one of the oldest pharmaceutical companies in India. APL is an integrated company having presence across the pharmaceutical value chain.
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