Intercept Pharma resolves patent dispute with Dr Reddys Labs over generic Ocaliva

Published On 2022-08-19 09:33 GMT | Update On 2022-08-19 09:33 GMT

Hyderabad: Intercept Pharmaceuticals Inc has said it entered into a settlement agreement with Dr Reddy's Laboratories resolving the previously disclosed patent litigation to market a generic version of Ocaliva (obeticholic acid) 5 mg and 10 mg tablets in the USA. Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC).

"Under the terms of the agreement, Intercept granted Dr. Reddy's a non-exclusive, non-sublicensable, non-transferable, royalty-free licence to commercialise its generic version of Ocaliva in the United States commencing on October 26, 2035, or earlier under certain circumstances," Intercept Pharmaceuticals in a regulatory filing said.

Similar patent litigation previously disclosed by the company against five other ANDA (Abbreviated New Drug Application) filers seeking approval to market generic Ocaliva remains pending, it further said.

For the full year 2021, Ocaliva net sales were USD 363.5 million including USA net sales of USD 260.8 million, which represented growth of 16 per cent as compared to the prior year.

Read also: Biocon, Celgene settle patent litigation over cancer drug Revlimid

In May 2020, Dr Reddy's said it has launched the generic version of Ocaliva in the Indian market.

Medical Dialogues had earlier reported that Dr Reddy's Laboratories had settled patent litigation with Indivior Inc and Aquestive Therapeutics on a medication used to treat opioid dependence or addiction.

Read also: Dr Reddys Labs settles patent litigation with Aquestive Therapeutics, Indivior

Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company headquartered in Hyderabad, Telangana, India. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology. Dr. Reddy's operates in markets across the globe. The company's major markets include - USA, India, Russia & CIS countries, and Europe.

Article Source : with inputs

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Intercept Pharma resolves patent dispute with Dr Reddys Labs over generic Ocaliva

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