Generics

Lupin is looking to be ready on day one to challenge Merck & Co’s Janumet (metformin/sitagliptin) treatment for type 2 diabetes, after the US Food and Drug Administration tentatively waved through its ANDA product.

Viatris is shedding another of its off-patent interests, striking a deal for Safecor Health to acquire its US unit-dose packaging business.

The latest update on product-specific guidances for generic development from the FDA included 60 new and newly-revised PSGs as well as an update on future guidances coming down the line in the next year.

The BGMA has lauded as “comprehensive and welcome” a report published by the Royal Pharmaceutical Society on UK shortages, just weeks after the BGMA put forward its own supply-chain policy proposals.

Mallinckrodt has spoken about maintaining a steady organization, underpinned by few launches in the pain and neurodevelopmental disorders space.

The first GLP-1 agonist to receive US Food and Drug Administration approval, Byetta (exenatide), has generic competition at last, with Amneal bagging the first rival after Teva seemingly abandoned its proposed generic version.

With a first wave of generic weight-loss medicines poised to hit the UK, local off-patent industry association the BGMA says market dynamics could be unlike those of a typical generic or biosimilar launch, with the current level of unmet demand unclear.

MSN Laboratories has struck a patent-litigation settlement deal with BeiGene that will allow it to launch its zanubrutinib generic rival to Brukinsa in the US from 2037.

The US Supreme Court has failed to come to the aid of Norwich Pharmaceuticals in its legal battle over a generic version of Xifaxan (rifaximin) that has a patented indication carved out of its label. An earlier decision over the generic thus bars approval and launch until 2029.

The UK’s National Health Service is set to roll out Teva’s varenicline smoking-cessation daily tablet to “tens of thousands” of smokers in England.

Biogen has struck another blow against European generic competitors to Tecfidera, after the European Patent Office upheld a dosage patent for the brand that runs until February 2028. Meanwhile, the firm reported flat biosimilars sales in the third quarter of 2024.

Generics of the schizophrenia treatment Latuda generated more than $4bn in savings a year after their 2022 approval, according to an FDA study.

Years after the patent application’s initial filing in 2007, the Indian Patent Office has dismissed ViiV’s claims in response to multiple opposition filings launched against the pharma player.

Accord has received a nod from the EMA for its Stelara biosimilar, while Neuraxpharm has seen a buprenorphine hybrid film endorsed and Viatris has received a positive CHMP opinion for an eltrombopag generic.

The latest twist in MSN’s legal fight with Novartis over Entresto has seen a US court rule that the FDA was correct to approve MSN’s skinny-label generic, which carves out certain protected Entresto indications. However, an appeal has already been filed and an imminent generic launch looks unlikely.

Lupin will benefit from 180 days of competitive generic therapy exclusivity as it launches the first and only US rival to the $200m brand Pred Forte.

With the UK generics market facing a rising number of supply issues, local off-patent industry association the BGMA has put forward a raft of policy proposals that it said could provide solutions.

The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.

Teva has resolved a pair of civil US Department of Justice lawsuits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act through its alleged conduct conspiring to fix the price of three generic drugs and for allegedly paying Medicare patients’ copays for its multiple sclerosis brand Copaxone.

In the space of a few days, all four generics manufacturers that had successfully petitioned for a re-examination of a key patent shielding Novo Nordisk’s mega blockbuster Ozempic have reached settlement agreements terminating their challenges.