Coming down heavily on Norwich Pharmaceuticals, a US district court has denied the US-based generics firm’s bid for relief post-judgment in a case involving the “hotly disputed” issue of skinny label ANDA products.
Norwich Pharmaceuticals has failed to get around an unfavorable US patent-infringement ruling over Bausch Health’s Xifaxan (rifaximin) by filing an amended ‘skinny label’ abbreviated new drug application with patent protected indications carved from the label.
Had it succeeded in its motion before a US district court in Delaware, Norwich would sought to have launched its proposed rifaximin skinny label generic for its irritable bowel syndrome with diarrhea (IBS-D) indication
Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.
Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.
Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.
Glenmark’s advantage for its UK generic version of AstraZeneca’s Forxiga (dapagliflozin) has quickly been snuffed out, after the originator won on appeal its request for injunctive relief.
Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.
Adalvo and Gedeon Richter have announced a global co-development deal for semaglutide for obesity. Adalvo CEO Anil Okay spoke to Generics Bulletin about the alliance as well as the broader competitive landscape for GLP-1s.
Reflecting on recent initiatives by NHS England and the MHRA, the newly renamed trade body Medicines UK has welcomed efforts in promoting the use of biosimilars in Britain.
