FDA approved

Natco Pharma Submits Application with FDA for Generic Olaparib

  • February 21, 2023
  • < 1 min read

On 13th February 2023, Natco Pharma announced it has submitted a new application with the USFDA for marketing authorization of the generic version of Olaparib tablets. The medicine Olapraib is used for the treatment of certain forms of Ovarian cancers, Breast cancers, Prostate cancers, and Pancreatic cancers.

Natco Pharma has submitted an ANDA or Abbreviated New Drug Application containing a PARAGRAPH IV certification with the US health regulator (FDA) for the medicinal product, a generic version of Olaparib pills, manufactured by AstraZeneca, in the strengths of 100 mg and 150 mg.

Tablets of Olaparib are marketed in the United States by AstraZeneca under the brand name Lynparza. The company said it has been named as a defendant in a lawsuit filed in the United States district court of New Jersey by AstraZeneca and Kudos Pharma.

Natco Pharma and its co-development and marketing associate Alembic Pharma believe that the ANDA is probably the sole first-to-file on behalf of its date of filing and may be eligible for 180 days of marketing exclusivity at the juncture of the launch of the medicinal product.

According to AstraZeneca, Lynparza (Olaparib 100 mg/150 mg tablets) recorded sales of 1,226 Billion USD in the US market for the year ending December 2022. Natco Pharma shares were trading 2.2% up at INR 537.50 apiece on the Bombay Stock Exchange.