Dr Reddy's gets FDA nod for generic Revlimid; Enjoys 180 days exclusivity
Dr. Reddy's Laboratories Ltd. has announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide capsules, from the U.S. Food and Drug Administration (USFDA).
![Dr Reddy's gets FDA nod for generic Revlimid; Enjoys 180 days exclusivity Dr Reddy's gets FDA nod for generic Revlimid; Enjoys 180 days exclusivity](https://cdn.zeebiz.com/sites/default/files/styles/zeebiz_850x478/public/2021/10/19/162922-untitled-design-2021-10-19t123652037.jpg?itok=5AtkZCtP&c=c5af8c0f92ccc8e249257bf0f1cb18e8)
Dr. Reddy's Laboratories Ltd. On Tuesday announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide capsules, from the U.S. Food and Drug Administration (USFDA).
According to a press release issued by the city-based drug maker, the FDA approved Lenalidomide capsules in 2.5 mg and 20 mg strengths, and gave tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths.
See Zee Business Live TV Streaming Below:
Lenalidomide is used to treat various types of cancers. With this approval, Dr. Reddy's is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg, it said.
In September 2020, Dr. Reddy's announced a settlement agreement of their litigation with Celgene, the maker of Revlimid (lenalidomide) capsules and a wholly-owned subsidiary of Bristol Myers Squibb relating to patents for the branded drug.
"We are pleased with the Agency's approval of Lenalidomide Capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity. We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients," Marc Kikuchi, CEO, North America Generics, Dr. Reddy's Laboratories said.
In settlement of all outstanding claims in the litigation, Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. Beginning on a confidential date after March 2022 subject to regulatory approval.
The agreed-upon percentages remain confidential. As part of the settlement, Dr. Reddy's is also licensed to sell generic lenalidomide capsules in the U.S. Without volume limitation beginning January 31, 2026, the release said.
Get Latest Business News, Stock Market Updates and Videos; Check your tax outgo through Income Tax Calculator and save money through our Personal Finance coverage. Check Business Breaking News Live on Zee Business Twitter and Facebook. Subscribe on YouTube.
RECOMMENDED STORIES
![https://www.zeebiz.com/personal-finance/photo-gallery-sip-swp-monthly-pension-income-retirement-corpus-planning-calculator-inr-rs-20000-monthly-investment-for-15-years-inr-99000-monthly-return-for-42-years-313283](https://cdn.zeebiz.com/sites/default/files/styles/zeebiz_700x394/public/2024/09/06/316973-rupee-pixabay-take-1.jpg?itok=02-hJh59)
SIP+SWP: Rs 20,000 monthly SIP for 16 years to get Rs 99,000 monthly income for 42 years; how is it possible?
![https://www.zeebiz.com/market-news/news-bajaj-finserv-rvnl-borosil-renewables-carysil-railtel-corporation-stocks-to-buy-hdfc-securities-recommendation-picks-target-stop-loss-bse-nse-313386](https://cdn.zeebiz.com/sites/default/files/styles/zeebiz_700x394/public/2024/09/06/317091-26.jpg?itok=gE1cWt7z)
RVNL, Bajaj Finserv and 5 more: Brokerage recommends buying these 7 stocks for up to 3 months | Check target, stop loss
![https://www.zeebiz.com/personal-finance/photo-gallery-nps-vs-ups-vs-ops-monthly-pension-income-retirement-corpus-calculator-what-will-be-your-pension-on-inr-rs-10000-contribution-for-35-years-expert-calculations-313361](https://cdn.zeebiz.com/sites/default/files/styles/zeebiz_700x394/public/2024/09/06/317060-rupee-pixabay-take-2.jpg?itok=cOVdof_v)
NPS vs UPS vs OPS: What will be your monthly pension if you contribute Rs 10,000 monthly for 35 years? Get expert calculations
![https://www.zeebiz.com/personal-finance/photo-gallery-top-7-etf-sip-mutual-funds-in-5-years-calculator-how-inr-rs-21000-monthly-investment-has-grown-in-nifty-sp-bse-next-50-cpse-uti-icici-pru-nippon-india-motilal-oswal-bharat-22-nift-mid-infra-313306](https://cdn.zeebiz.com/sites/default/files/styles/zeebiz_700x394/public/2024/09/06/316994-indian-currency-pixabay-take-1.jpg?itok=JURVEkst)
Top 7 ETF Mutual Funds With Highest SIP Returns in 5 Years: How Rs 21,000 monthly SIP has grown in each ETF over the years
![https://www.zeebiz.com/personal-finance/photo-gallery-sbi-senior-citizen-fd-fixed-deposit-latest-interest-rate-2024-calculator-what-be-maturity-amount-with-return-on-investments-of-inr-900000-lakh-in-1-3-5-year-guaranteed-return-scheme-retirement-planning-313221](https://cdn.zeebiz.com/sites/default/files/styles/zeebiz_700x394/public/2024/09/06/316909-note-coin-pixabay-take-1.jpg?itok=3RPKcBYE)
SBI Senior Citizen FD Rates 2024: What you can get if you invest Rs 3 lakh, Rs 5 lakh, Rs 7 lakh, and Rs 9 lakh in 1-, 3-, and 5-year FDs
12:42 PM IST