USFDA Approves NATCO Pharma Everolimus Tablets

NATCO Pharma Ltd has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Everolimus tablets for oral suspension (TFOS) in 2mg, 3mg, and 5mg strengths. The drug is a generic version of AFINITOR DISPERZ, manufactured by Novartis Pharmaceutical Corporation.

NATCO Pharma Ltd is trading at ₹1,163.80, down ₹7.20 (0.61%) today as of January 30, 12:35 PM; the stock has dropped 16.71% in the past month but remains up 33.71% over the past year.

Usage and Indication

Everolimus TFOS is used in adults and children aged one year and older who have tuberous sclerosis complex (TSC), a condition that can cause subependymal giant cell astrocytoma (SEGA). The drug is prescribed for cases where the tumour cannot be removed surgically and requires medical treatment.

Market Size and Competition

According to industry sales data, Everolimus tablets for oral suspension generated approximately $112 million in the US for the 12 months ending September 2024. NATCO’s version enters a limited-competition market, offering a lower-cost alternative to the existing brand-name drug.

NATCO’s marketing partner, Breckenridge Pharmaceutical, Inc., plans to launch the drug immediately in the US market.

Company Overview

Headquartered in Hyderabad, India, NATCO Pharma develops generic and speciality pharmaceuticals, active pharmaceutical ingredients (APIs), and crop protection products. It operates nine manufacturing facilities and two R&D centres in India. 

The company’s plants are approved by regulatory authorities such as the USFDA, Health Canada, Brazil ANVISA, and the WHO, and it supplies products to over 50 countries.

Regulatory Disclosure

The announcement was made in a regulatory filing under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company informed BSE and NSE about the approval.

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