Will MSN Push On With US Generic Entresto Launch By The Week’s End?

Novartis Petitions Court Claiming ‘MSN Has Threatened Imminent Launch’

Novartis has been spooked by the potential for MSN Laboratories to launch its generic version of the originator’s $3bn Entresto (sacubitril/valsartan) heart failure brand, filing an emergency motion in an appeals court in Washington DC just days ahead of the proposed expiry of one of Entresto’s US patents.

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Fighting tooth and nail to keep its $3bn Entresto (sacubitril/valsartan) heart failure brand from generic competition, Novartis has petitioned an appeals court in Washington DC for an emergency motion for administrative stay and further suspension of proceedings.

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Teva Provigil ‘Pay For Delay’ Fines Should Stand, AG Says

 
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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.

Five-Year Extension Found Just, As Aurobindo Loses On US Sugammadex Appeal

 
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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.

MSN’s US Entresto Generic Blocked In Part For Being Too Similar To The Brand

 
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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 Pursues Generics Industry Leaders Over Price-Fixing

 
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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.

More from Generics Bulletin

Richter Confirms European Tocilizumab Filing

Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.

Accord’s Denosumab Biosimilars Get Thumbs-Up From EMA

 
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Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.

IGBA Warns Of Harmful Impact Of Tariffs On Generic Drug Supply

 
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Echoing wider sentiments in the biosimilar and generic drug industry, the IGBA has warned of the potential consequences of mercantilist tariffs on the global drug supply and their impact on industry and patients.