Latest news with #ADPKD
Business Standard
13-05-2025
- Business
- Business Standard
Lupin launches Tolvaptan Tablets in US market with 180-day exclusivity
Following the recent approval received from the United States Food and Drug Administration (U.S. FDA), Lupin today announced the launch of Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the United States. Lupin holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity. Tolvaptan Tablets are bioequivalent to Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
Business Standard
13-05-2025
- Business
- Business Standard
Lupin rises after launching Talvaptan tablets in US market
Lupin gained 2.81% to Rs 2,098.35 after the company announced the launch of Tolvaptan Tablets in the U.S. market, with 180-day exclusivity under the first-to-file status. The tablets are the generic version of Jynarque, developed by Otsuka Pharmaceutical Company, and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). The product has an estimated annual market size of $1,467 million in the U.S. for the fiscal year ended 31 December 2024. Vinita Gupta, CEO of Lupin, said, We are pleased to announce the launch of Tolvaptan Tablets in the U.S. to provide ADPKD patients with increased access to high-quality treatment options. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit jumped 39.5% to Rs 855.16 crore in Q3 FY25 as compared with Rs 613.12 crore in Q4 FY24. Net sales increased 10.6% YoY to Rs 5618.56 crore during the quarter ended 31st March 2025.
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Business Standard
13-05-2025
- Business
- Business Standard
Lupin shares gain 4% on Tolvaptan Tablets launch in US; details here
Lupin share price today, May 13, 2025: Shares of pharma major Lupin were in demand on the bourses in an otherwise weak market on Tuesday, May 13, 2025. The company's shares climbed 3.65 per cent to ₹2,114.30 per share on the National Stock Exchange (NSE) during intra-day deals on Tuesday. The uptick in Lupin's share price came after the pharma major announced the launch of Tolvaptan Tablets—15 mg, 30 mg, 45 mg, 60 mg, and 90 mg—in the United States, following recent approval received from the United States Food and Drug Administration (US FDA). Lupin, in a release, said that it holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity. Tolvaptan Tablets, according to the release, are bioequivalent to Jynarque® Tablets (15 mg, 30 mg, 45 mg, 60 mg, and 90 mg) of Otsuka Pharmaceutical Company, and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). "We are pleased to announce the launch of Tolvaptan Tablets in the US to provide ADPKD patients with increased access to high-quality treatment options,' said Vinita Gupta, CEO of Lupin. Tolvaptan Tablets (RLD Jynarque®) had estimated annual sales of USD 1,467 million in the US for the fiscal year ended December 31, 2024. About Lupin Headquartered in Mumbai, Lupin is a global pharmaceutical company with products distributed in over 100 markets. Lupin specialises in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company enjoys a strong position in India and the US across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. As of May 13, Lupin enjoys a market capitalisation of ₹95,743.36 crore on the NSE. Lupin share price history The company's share price has yielded a return of 4 per cent in the last one month, 3 per cent in the last three months, and 24 per cent in the last one year. However, for the year-to-date, Lupin's share price has declined 11 per cent. In contrast, the Nifty50 has advanced 4 per cent year-to-date. The pharmaceutical company has a 52-week range of ₹2,402.90 - ₹1,493.30 per share on the NSE. At 12:20 PM on Tuesday, Lupin shares were trading at ₹2,082.50 apiece, up 2.09 per cent from its previous close of ₹2,039.80 on the NSE. In contrast, the benchmark Nifty was trading lower by 205 points or 0.82 per cent at 24,719.20.
Time of India
13-05-2025
- Business
- Time of India
Lupin launches generic version of kidney disorder treatment drug in US
Pharma major Lupin Ltd on Tuesday said it has launched the generic version of Tolvaptan tablets used to slow kidney function decline in the US market , following the recent approval received from the country's health regulator. The company has launched Tolvaptan tablets of strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the US, after receiving the approval from the US Food and Drug Administration ( USFDA ). #Operation Sindoor The damage done at Pak bases as India strikes to avenge Pahalgam Why Pakistan pleaded to end hostilities Kashmir's Pahalgam sparks Karachi's nightmare "Lupin holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity," Lupin said in a statement. Tolvaptan tablets are bioequivalent to Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company, Ltd, and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), it added. Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like She is Revealing Her Secret Strategy in Commodity Trading TradeWise Learn More Undo by Taboola by Taboola Lupin CEO Vinita Gupta said the launch of Tolvaptan Tablets in the US will provide ADPKD patients with increased access to high-quality treatment options.
Business Upturn
13-05-2025
- Business
- Business Upturn
Lupin launches Tolvaptan tablets in the US for ADPKD treatment
By Aman Shukla Published on May 13, 2025, 12:00 IST Lupin Limited, a global pharmaceutical company, has announced the launch of its generic Tolvaptan Tablets in the United States following approval from the U.S. Food and Drug Administration (FDA). The product is available in multiple strengths: 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. Tolvaptan Tablets are the generic equivalent of Jynarque®, a brand-name medication developed by Otsuka Pharmaceutical Company, Ltd. The drug is used to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Lupin has secured exclusive first-to-file status for the generic version of Tolvaptan, which grants the company 180 days of marketing exclusivity in the U.S. market. This exclusivity period allows Lupin to be the only generic manufacturer selling the product during that time. Vinita Gupta, CEO, Lupin, stated, 'We are pleased to announce the launch of Tolvaptan Tablets in the U.S. to provide ADPKD patients with increased access to high-quality treatment options.' According to available data, Jynarque® recorded estimated U.S. sales of approximately $1.467 billion for the fiscal year ending December 31, 2024. The launch of Tolvaptan Tablets is part of Lupin's strategy to expand its portfolio of affordable treatments in the U.S. pharmaceutical market. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
