Lupin receives USFDA approval for its generic formulation of Emtricitabine and Tenofovir Alafenamide Tablets, offering a cost-effective alternative for HIV treatment and prevention.
Global pharmaceutical leader Lupin Limited has achieved a significant milestone with the U.S. Food and Drug Administration (USFDA) granting approval for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg. This approval allows Lupin to market a generic version of Descovy Tablets, originally developed by Gilead Sciences, Inc.
Key Details of the Approval
- Generic Drug: Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg.
- Reference Listed Drug (RLD): Descovy Tablets by Gilead Sciences, Inc.
- Exclusivity: Lupin is one of the first ANDA applicants to receive approval, securing 180 days of shared generic market exclusivity.
- Manufacturing Facility: Lupin’s state-of-the-art facility in Nagpur, India, will produce the approved drug.
Indications for Use
- Treatment of HIV-1 Infection: Effective for adults and adolescents diagnosed with HIV-1.
- Pre-Exposure Prophylaxis (PrEP): Helps reduce the risk of HIV-1 infection in high-risk individuals.
Market Insights
The approved generic drug is expected to offer a cost-effective alternative to Descovy, a widely prescribed medication with estimated annual U.S. sales of $3.556 billion (IQVIA MAT, October 2024). This development highlights Lupin’s commitment to providing accessible healthcare solutions globally.
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Impact on the Pharmaceutical Industry
This approval underscores Lupin’s expertise in developing high-quality generic formulations. It not only enhances competition in the HIV treatment market but also ensures affordable options for patients. The company’s focus on innovation and quality has solidified its reputation as a global pharmaceutical leader.
For more details about Lupin’s achievements and product portfolio, visit their official website.
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