Alembic resolves generic capsules` patent case with Novartis
New Delhi: Alembic Pharmaceuticals today said it along with Breckenridge Pharmaceutical Inc, USA has settled patent case with Novartis for Rivastigmine Tartrate capsules used for treating dementia.
The companies have settled their Paragraph IV patent litigation with Novartis for Rivastigmine Tartrate capsules which are a generic version of Exelon capsules of Novartis, Alembic Pharmaceuticals said in a filing to BSE.
Under the terms of the settlement agreement, Novartis has granted the two companies a licence to market their generic capsules before the date of the patent expiry, it added.
The companies will launch the product immediately in the American market, Alembic Pharmaceuticals said.
United States Food and Drug Administration (USFDA) has approved their abbreviated new drug application (ANDA). While the Indian firm is the sponsor and manufacturer of the ANDA, the product will be marketed exclusively by Breckenridge.
Rivastigmine Tartrate capsules are prescribed for mild to moderate dementia of Alzheimer`s type and mild to moderate dementia associated with Parkinson`s disease, the company said.
The product will be available in the strengths of 1.5 mg, 3 mg, 4.5 mg and 6 mg, it added.
Shares of Alembic Pharmaceuticals today closed at Rs 53.70 apiece on BSE, up a steep 4.58 per cent from its previous close.
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