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Lupin Secures FDA Nod for First-to-File Generic HIV Drug

5 Feb 2025 , 09:27 AM

Lupin Ltd’s generic version of a combination HIV treatment receives tentative approval from US FDA. Lupin Ltd has received tentative approval from the FDA for its generic version of a combination HIV treatment.

Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets are therapeutic equivalents of Symtuza Tablets 800 mg/150 mg/200 mg/10 mg brand of Janssen Products, LP.

According to IQVIA MAT December 2024, this drug will generate a U.S. market sales revenue of $1,374 million. Lupin is the first-to-file applicant for this generic product. Being the first-to-file applicant provides the company with an edge in the market.

The drug shall be manufactured from Lupin’s Nagpur facility in India. The company mentioned that it did not release the information of approval as the same was not meeting the criteria of SEBI listing regulations regarding material events. Lupin assured that all material events and information are disclosed as per regulatory requirements.

In the National Stock Exchange, shares of Lupin is currently trading at ₹2139 which is a 1.32% gain than the previous close. The stock has gained a total of 35% in the last one year, and witnessed a 9% dip in the last one month.

Related Tags

  • Lupin
  • Pharma news
  • USFDA
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