A private security guard looks out from a window of the head office of Natco in the southern Indian city of Hyderabad March 13, 2012. India's move to strip German drugmaker Bayer of its exclusive rights to a cancer drug has set a precedent that could extend to other treatments, including modern HIV/AIDS drugs, in a major blow to global pharmaceutical firms, experts say. On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India. REUTERS/Krishnendu Halder (INDIA - Tags: HEALTH BUSINESS) | Photo Credit: KRISHNENDU HALDER
Natco Pharma Limited has received the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide capsules from the US Food and Drug Administration (FDA).
Hyderabad-based Natco, along with its marketing partner Arrow International Limited (a US affiliate of Teva Pharmaceutical Industries Ltd), previously settled the Paragraph IV litigation related to the product with Celgene (now part of Bristol-Myers Squibb), who sells the product under the brand name Revlimid.
Natco’s marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its ANDA for Everolimus tablets (generic for Zortress) from the USFDA. BPI plans to launch 0.25 mg, 0.5 mg and 0.75 mg strengths of the product shortly.
The above strengths of the drug are indicated in the Prophylaxis of Organ Rejection in Kidney Transplantation and Liver transplantation, according to a release.
As per industry sales data, Zortress and its therapeutic equivalents had generated annual sales of $162 million during the twelve months ending March 2021 in the US.
Published on May 22, 2021
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