Sandoz has yielded to the intellectual property shielding Intra-Cellular Therapies’ closely-watched schizophrenia and bipolar depression brand Caplyta (lumateperone) capsules, striking a patent-litigation settlement agreement that – for now – ensures that the antipsychotic will all but reach its ultimate patent expiry in December 2040.
Sandoz Settlement Suggests J&J Buyout Caplyta May Be Tough Nut To Crack
Six More ANDA Filers In Play But Analysts Feel IP Estate May Be Stronger Than Suspected
Sandoz is facing a lengthy wait for its proposed generic version of the touted mega blockbuster Caplyta (lumateperone), while the market waits with anticipation to see if the product’s robust IP can hold up to challenges from an additional six ANDA filers.

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In a precedential decision, the US Court of Appeals for the Federal Circuit has determined the meaning of the language “the patent” as it applies to patent-term extensions for reissued patents, in the context of Aurobindo’s bid to wipe out a reissued patent shielding Merck & Co’s Bridion (sugammadex) injectable.
Novartis’ multi-front legal battle against MSN Laboratories over its Entresto blockbuster in the US has taken yet another twist, with a federal district court in New Jersey finding that a preliminary injunction was warranted against MSN’s product on the basis of infringement of Novartis’ trade dress.
Walmart has launched an attack on a host of industry-leading generics firms over historical price-fixing allegations, with the US retail giant seeking treble damages from a Pennsylvania district court.
Amgen’s biosimilar aflibercept formulation is keeping it head and shoulders above other would-be Eylea biosimilar competitors, while continuing to frustrate originator Regeneron’s push to block sales of the product while it battles Amgen over alleged infringement of a key US patent.
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With sales and profits shooting up in 2024, Alvotech has revealed plans to rapidly accelerate development to add between four and six programs to its pipeline of biosimilars every year, while at the same time unveiling details of several new brands that it will be seeking to challenge. The firm has also set out longer-term financial targets that anticipate more than trebling its revenues in the next three years.
The Chinese player reported its second profitable year in a row, with growth in sales reported across its marketed portfolio and further milestones in the near future.
India’s Dr Reddy’s and China’s Bio-Thera have struck a deal covering ustekinumab and golimumab biosimilars in multiple markets in south-east Asia.