NATCO files generic Olaparib Tablets in USA
2023-02-13 · NATCO Pharma Ltd. · original natcopharma.co.in ↗
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Olaparib Tablets 100mg and 150mg. Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer. Olaparib Tablets are marketed in the United States (US) by AstraZeneca under brand Lynparza®. 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 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. Lynparza® has recorded sales of USD 1,226 million in the US market for the year ending December 2022, as per AstraZeneca results presentation. Lynparza® is a registered trademark of the AstraZeneca group of companies 3:T11c6, Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 513.3 Crore, for the Third quarter ended on 31" December, 2022, as against INR 590.7 Crore for the same period last year that had a one-time licensing revenue. The net profit for the period, on a consolidated basis, was INR 62.3 Crores as against INR 80.4 Crore same period last year. For 9 months ending December 31", 2022, the company recorded total revenue of INR 1884.8 Crore as against INR 1433.2 Crore for same period last year and on the net profit side, the company recorded INR 439.5 Crore as against INR 220.5 Crore. Segmental Revenue Split (All Figures In INR Crore) Segment Revenue, Q3 FY23 Revenue, Q2 FY23 Revenue, Q3 FY22 API 42.6 44.1 61.7 Formulations, Domestic 101.1 93.5 100.3 Formulations, Export (incl. Profit Sharing & Foreign Subs) 333.7 283.4 383.1 Other Operating income & non-operating income 26.0 28.6 45.3 Crop Health Sciences (CHS) 9.9 3.0 0.3 TOTAL 513.3 452.6 590.7 The Board of Directors has declared 3rd interim dividend of INR 1.25 per equity share, for FY 2022-23. 4:T5ed, We are organising a conference call with the management of Natco Pharma to discuss the Company’s Q3 FY23 financial results on Friday, February 10, 2023 at 11.00 AM IST. Mr. Rajeev Nannapaneni, Director & Chief Executive Officer and Mr. Rajesh Chebiyam , Executive Vice President – Crop Health Sciences will represent Natco Pharma on the call. Click here for more information
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