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Natco Pharma Shares Up 4% on Filing Generic Version of Oncology Drug in US

Natco Pharma announced the submission of an ANDA to the USFDA for generic olaparib tablets.

Shares of Natco Pharma rose 4.5% to Rs 549 a share in intraday trade on Monday after the company submitted a generic version of an anti-tumour drug in the US market. In contrast, the S&P BSE Sensex fell 0.6% to hit a low of 60,283 on the day.

The drug speciality company submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (USFDA) for generic olaparib tablets — 100 mg and 150 mg. Olaparib mainly treats ovarian, breast, pancreatic and prostate cancer.

Because AstraZeneca markets olaparib tablets in the US under the brand name Lynparza, the pharmaceutical giant informed that it is named as a defendant in a lawsuit filed by AstraZeneca and Kudos Pharmaceuticals in the US District Court of New Jersey.

That said, NATCO and its co-development marketing partner Alembic Pharmaceuticals believe that the ANDA’s first-to-file basis could qualify companies for 180 days of marketing exclusivity upon product launch.

Shares of Natco Pharma are down 37% from Rs 770 per share so far this fiscal (FY23), while the S&P BSE Sensex has gained 3%. The stock hit a 52-week high of Rs 936 per share on February 15, 2022, before plunging to a 52-week low of Rs 502 per share on February 2, 2023.

In the October-December quarter of FY2023, Natco Pharma’s revenue fell 12% year-on-year to Rs 490 crore but rose 14% quarter-on-quarter. While Indian formulations reached Rs 100 crore, up 7% QoQ, export formulations rose 18% QoQ due to higher shipments of gRevlimid.

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