Lupin Receives FDA Approval for Generic Emtricitabine & Tenofovir

Lupin, the Mumbai-based pharmaceutical giant, has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg. This approval marks another milestone for the company in its mission to provide affordable, high-quality treatments and strengthens its presence in the U.S. pharmaceutical market.

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The Emtricitabine and Tenofovir Alafenamide combination is used alongside other medications to treat human immunodeficiency virus (HIV) infection, the virus responsible for acquired immune deficiency syndrome (AIDS). It is also prescribed as a pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection in high-risk individuals. The approved generic drug is the equivalent of Descovy Tablets, manufactured by Gilead Sciences, Inc. Lupin, being one of the first applicants for this ANDA, is now eligible for 180 days of shared generic exclusivity, giving it a competitive edge in the market. The product will be manufactured at Lupin’s Nagpur facility in India.

In addition to this approval, Lupin has received several other FDA approvals recently, further strengthening its portfolio of generic medicines. These approvals include:

1. Raltegravir Tablets USP, 600 mg – A generic version of a medication used to treat HIV-1 infection. Lupin received tentative approval for this drug.

2. Inderal LA Extended-Release Capsules – Lupin received approval for the generic version of ANI Pharmaceuticals’ Inderal LA extended-release capsules, used in the management of hypertension.

3. Pitavastatin Tablets (1 mg, 2 mg, and 4 mg) – A generic cholesterol-lowering drug approved by the FDA.

4. Loteprednol Etabonate Ophthalmic Suspension – Lupin obtained approval for this medication used to treat eye inflammation.

These recent approvals reflect Lupin’s commitment to expanding its range of generic medicines and addressing critical healthcare needs. FDA approval indicates that a drug’s benefits outweigh its known and potential risks for the intended population, thereby enhancing Lupin’s credibility and market reach.

Lupin’s business spans over 100 markets worldwide, including the U.S., India, South Africa, Latin America, Europe, and the Asia Pacific region. The company focuses on the development and commercialization of a diverse portfolio of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs). Its Nagpur facility, where the Emtricitabine and Tenofovir Alafenamide Tablets will be produced, is part of the company's extensive manufacturing network.

The recent financial performance of Lupin has also shown a significant improvement. The company reported a 74.1% jump in consolidated net profit to Rs 852.63 crore in Q2 FY25, compared to Q2 FY24. Sales grew by 11.3% to Rs 5,497.01 crore during the same period. This financial growth reflects Lupin’s strategic focus on innovation, cost efficiency, and expanding its product offerings in key markets.

Despite the positive news, shares of Lupin experienced a slight dip of 0.13%, trading at Rs 2,096 on the Bombay Stock Exchange (BSE). This minor fluctuation is common in the pharmaceutical sector, where stock prices are often influenced by various market dynamics.

Conclusion

Lupin’s recent FDA approvals, including the generic version of Emtricitabine and Tenofovir Alafenamide Tablets, are expected to strengthen its foothold in the U.S. market and further enhance its reputation as a leading pharmaceutical player. With a focus on innovation, manufacturing excellence, and expanding its product portfolio, Lupin is well-positioned to drive future growth and provide affordable healthcare solutions worldwide.