Following the decision by the US Court of Appeals for the Federal Circuit not to rehear “en banc” Teva’s litigation with GSK revolving around skinny-label generic carvedilol, the Israeli company has confirmed that it will seek Supreme Court review of the ruling.
While the recent decision by the US Court of Appeals for the Federal Circuit not to further rehear Teva’s litigation with GlaxoSmithKline over its skinny-label generic version of Coreg (carvedilol) represented a setback for the Israeli firm, it is by no means the end of the story.
In the latest development in what has become a long-running saga – with potentially significant and wide-ranging ramifications for the US convention of carving out patented indications from generic labels – Teva
Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”
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.
With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.
Teva’s plans to generate net savings of $700m by 2027 have been described by the firm as a journey and not a destination, with the suggestion that “this era of cost efficiency, harmonization, frugality will continue.”
Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.
