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Natco Pharma Ltd. — Capital/Financing Update 2021
Apr 10, 2021
62741_rns_2021-04-10_834aee93-d4de-4951-8cd8-ab41e8f633d7.pdf
Capital/Financing Update
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April 10, 2021
Corporate Relationship Department The Manager – Listing M/s. BSE Limited M/s. National Stock Exchange of India Ltd Dalal Street, Fort, “Exchange Plaza”, Bandra Kurla Complex Mumbai 400 001 Bandra (E) ) Mumbai 400 051 Scrip Code: 524816 Scrip Code: NATCOPHARM
Dear Sir
Please find enclosed the Press Release for your information.
Thanking you
Yours faithfully for NATCO Pharma Limited
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M Adinarayana Company Secretary & Vice president (Legal & Corp Affairs)
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Ref: PR/1 /2021-2022 April 10, 2021
NATCO receives tentative approval for Ibrutinib tablets (generic for IMBRUVICA[ ®] ) ANDA in the US market
Hyderabad, India, April 10[th] , 2021
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing and distribution partner Alvogen Pine Brook LLC, has received tentative approval for our Abbreviated New Drug Application (ANDA) for Ibrutinib Tablets 560mg, 420mg, 280mg and 140mg strengths (generic for IMBRUVICA[®] ), from the U.S. Food and Drug Administration (USFDA).
Based on our ANDA filing date and the approval timeline, NATCO believes that we are eligible for 180 days of sole generic marketing exclusivity for all the strengths of the tablet dosage form of the product at the time of launch.
As per industry sales data, IMBRUVICA® (Tablet and Capsule dosage forms) had generated annual sales of $3.7 billion during the twelve months period ending December 2020 in the US market, of this, all the strengths of IMBRUVICA® Tablets alone generated sales of $3.0 billion during the same period.
*All brand names and trademarks are the property of their respective owners.
Forwarded for favour of publication For NATCO Pharma Limited
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M Adinarayana Company Secretary & Vice president (Legal & Corp Affairs)