Shares of Lupin Ltd were trading flat on 9 May after the company announced securing approval from the United States Food and Drug Administration (USFDA) for Raltegravir Tablets.
In its regulatory filing, the company said, “The company. has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Raltegravir Tablets USP, 600 mg.”
Raltegravir Tablets are bioequivalent to Merck Sharp & Dohme LLC’s Isentress HD Tablets, 600 mg. Lupin is the sole first-to-file for this medication and is entitled to 180 days of generic medicine exclusivity. This product will be produced at Lupin’s Nagpur plant in India.
Raltegravir Tablets USP, 600 mg, are used in combination with other antiretroviral medicines to treat human immunodeficiency virus (HIV-1) infection in adults and children weighing at least 40 kg.
Following the clearance of its ANDA by the US FDA, the worldwide pharmaceutical company launched Eslicarbazepine Acetate Tablets in strengths of 200 mg, 400 mg, 600 mg, and 800 mg on 7 May. Lupin is one of the first ANDA candidates and is entitled to 180 days of shared generic exclusivity.
Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg are bioequivalent to Sumitomo Pharma America, Inc.’s Aptiom Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, and are recommended for the treatment of partial-onset seizures in patients aged 4 years and up.
The company’s board of directors will meet on Wednesday, 14 May, 2025, to evaluate and approve the audited standalone and consolidated financial statements for the quarter and year ended 31 March, 2025, as well as to suggest any dividends.
Pharma stocks have recently remained under pressure following President Trump’s executive order to promote local drug production facilities.
At 1:28 pm, the shares of Lupin were trading 0.50% lower at Rs 2,004.80 on NSE.
Wondering About Lupin Ltd? The Analyst Has Answers.
Feeling overwhelmed by the markets? Let Unicorn Signals be your guide. Our user-friendly app simplifies complex data and provides actionable trading signals. Download the app today and trade with confidence!
