Vectura has won an award of almost $90m after convincing a Delaware jury that GSK’s Ellipta respiratory range infringed one of its US patents. The firm currently has a development deal with Hikma for generic versions.
Vectura’s US patent 8,303,991 has been found to be valid and infringed by US sales of three of GlaxoSmithKline’s Ellipta respiratory products, following a jury trial in a Delaware district court.
Having struck a deal with Vectura in 2010, through which GSK licensed formulation technology – covered by a family of...
In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.
Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.
Just days after a court in Canada barred Amgen’s Soliris biosimilar until patent expiry in 2027, a UK High Court has handed a favorable ruling to the California-based firm and Samsung Bioepis, ruling that their products do not infringe a patent shielding the branded treatment for paroxysmal nocturnal hemoglobinuria.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.
Several years after the initial signing of their agreement, Formycon and Fresenius Kabi announced the launch of their Stelara biosimilar Otulfi in Canada, adding another key market to their list.
A weak second half in Glenmark’s India business during the firm’s 2025 financial year took the gloss off its earnings somewhat for the year. However, Glenmark is plotting several avenues to return to growth, in both of its core business regions: India and the US.
Marking its first vertically integrated GLP-1 product in India, Biocon said the generic liraglutide was approved under CDSCO’s Rule 101, which recognizes approvals from “established and referenced serious regulatory authorities.”
