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.
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.
The move follows the US Court of Appeals for the Federal Circuit lifting an administrative injunction late last week precluding MSN Laboratories from launching its US Food and Drug Administration-approved...
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.
After being refused an injunction as part of ongoing litigation over a private-label ustekinumab biosimilar being marketed in the US by Sandoz and Samsung Bioepis, Stelara originator Johnson & Johnson is continuing to pursue an appeal. However, newly-unsealed court documents suggest the brand company had demonstrated a likelihood of success - and reveal further details about the case, including the identity of the PBM involved and why the injunction request was denied.
Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.
Teva has laid out an ambitious goal for its long-acting injectable schizophrenia drugs to grow into a $2bn franchise, ahead of the planned US filing of olanzapine later this year.
Competition to Amgen’s Prolia and Xgeva denosumab brands has hit the US market, with Sandoz taking the lead by launching its interchangeable Jubbonti and Wyost biosimilars.
Generics Bulletin previews the most noteworthy and anticipated events for June 2025.
