Natco Pharma gains on filing for generic Olaparib tablets in US

Natco Pharma rose 2.38% to Rs 538.45 after the company announced submission of abbreviated new drug application (ANDA) containing a paragraph IV certification with US Food and Drug Administration (USFDA) for generic version of Olaparib tablets.

Olaparib tablets are indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer. The said drug is marketed in the United States (US) by AstraZeneca under brand Lynparza.

Lynparza has recorded sales of $1,226 million in the US market for the year ending December 2022.

NATCO 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 are 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.

Natco Pharma is engaged in the business of pharmaceuticals which comprises research and development, manufacturing and selling of bulk drugs and finished dosage formulations. The company has manufacturing facilities in India which caters to both domestic and international markets including regulated markets like United States of America and Europe.

The company's consolidated net profit tumbled 22.5% to Rs 62.30 crore on 12.1% decline in net sales to Rs 492.50 crore in Q3 FY23 over Q3 FY22.

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