Natco Pharma on Monday said it has submitted a new application with the US health regulator for marketing authorisation of the generic version of Olaparib tablets, used in treating certain forms of ovarian, breast, pancreatic and prostate cancers, via an exchange filing.
The company has submitted an Abbreviated New Drug Application (ANDA) containing a 'paragraph IV' certification with the US Food and Drug Administration (FDA) for the product, a generic version of AstraZeneca's Olaparib tablets in strengths of 100mg and 150mg.
Olaparib tablets are marketed in the US by AstraZeneca under brand Lynparza. Natco Pharma said it has been named as defendant in a lawsuit filed in the US district court of New Jersey by AstraZeneca and Kudos Pharmaceuticals.
"Natco and its co-development and marketing partner Alembic Pharmaceuticals believe that the ANDA is possibly sole first-to-file based on its filing date and may be eligible for 180 days of marketing exclusivity at the time of launch of the product," it added.
Lynparza had sales of USD 1,226 million in the US market for the fiscal year ending December 2022, according to AstraZeneca.
On the BSE, Natco shares were trading 2.2 percent higher at Rs 537.50 per share.
With inputs from Agencies.
