The latest ruling comes just four months ahead of the expiry of BMS' patent on Nivolumab, sold under the brand name Opdiva, which is due to lapse on May 2, 2026.
The deal involves an upfront payment of $75 million, with an additional contingent payment of up to $50 million over three years
In recent past, U.S President Trump had signalled at potential tariffs on pharma imports as well, calling for bringing overseas manufacturing back to America.
Speaking at an event, he stressed the need for innovation, capability building, and a focus on societal benefit.
The first order impact will be a slow market share gain from innovators after a generic launch
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For Zydus, this acquisition marks a strategic foray into specialized biotech products targeting health and nutrition, particularly for consumers who prefer animal-free protein or are lactose intolerant.
Following the approval by Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), for Mamitra, the drug will be marketed in different strengths of 150 mg and 440 mg, Zydus Lifesciences said in a regulatory filing.
The approval by the US Food and Drug Administration (USFDA) is to manufacture and market Isosorbide Mononitrate Extended-Release, of strengths 30 mg, 60 mg, and 120 mg, Zydus Lifesciences said in a regulatory filing.
Prostate cancer is one of the leading cancers in men and more than 43,000 cases were reported in India in 2022 as per the National Cancer Registry Program of India.
The drug maker is the first company to receive final approval for generic Gabapentin tablets (300 mg and 600 mg), it added. The product will be launched immediately in the US market, the drug firm stated.
ZHL does not expect the said intimation to have any material financial impact as the above-mentioned adjustments are not sustainable in law and are wholly defendable on the facts of the case, the company added
The company has received final approval from the US Food and Drug Administration (USFDA) for Darunavir Tablets, the company said in a statement.
The majority of current market usage is still on the ampoule presentation whereas Zydus is offering a generic version of Methylene Blue injection in vial presentation, the pharma company said.
There is a steady progress in product approvals and clinical trials for Zydus' niche products meant for rare ailments
Saroglitazar Mg, approved by the DCGI, is an innovative drug from Zydus to treat chronic liver diseases such as non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steato Hepatitis (NASH).
Zydus added that LiqMeds Group has capabilities and specialisation in development, manufacturing and supply of oral liquid products for global markets, which it currently commercializes through partners.
Desidustat is first-of-its-kind oral treatment for anemia associated with Chronic Kidney Disease in India.