Lupin Limited a major global pharmaceutical announced on November 18th that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg.
The approved drug is a generic equivalent of Descovy Tablets, 200 mg/25 mg, originally developed by Gilead Sciences, Inc. Lupin is among the first Abbreviated New Drug Application ANDA applicants for this formulation, earning it 180 days of shared generic exclusivity in the U.S. market. The tablets will be manufactured at Lupin’s Nagpur facility in India.
Emtricitabine and Tenofovir Alafenamide Tablets are indicated for the treatment of HIV-1 infection as well as for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection in adults and adolescents. The reference drug, Descovy, recorded estimated annual sales of USD 3.56 billion in the U.S. as of October 2024, according to IQVIA.
Market Impact and Company Statement
Following the announcement, Lupin’s shares remained in focus, closing on 18th Nov at ₹2,098.7, up 2.6% on the BSE, even as the benchmark Sensex declined by 0.62%. The stock has gained 60% in 2024 and 188% over the past two years, with the company’s market capitalization now standing at ₹95,742 crore.
In an exchange filing, Lupin confirmed the USFDA approval, emphasizing its commitment to timely and transparent communication under SEBI Listing Regulations. The company noted that while this approval was not considered material under Regulation 30 at the time, it remains dedicated to prompt disclosure of any future material developments.
Lupin reiterated that it is not aware of any other undisclosed material information, stating, “The company makes prompt disclosures as and when required under the SEBI Listing Regulations and shall continue to do so.”
This milestone approval strengthen Lupin’s position in the competitive pharmaceutical market while enhancing access to essential HIV treatments in the U.S.
Source of Information:-https://m.economictimes.com/markets/stocks/news/lupin-shares-in-focus-after-fda-approval-for-generic-hiv-tablets/amp_articleshow/116457288.cms
