ANDA sponsors targeting Neurocrine Biosciences’ Ingrezza (valbenazine) blockbuster are in position to launch – albeit with a 14-year wait that validates the strength of the originator’s IP.
Lupin will look to enjoy a seven-month advantage over its rival Indian firm Zydus Lifesciences in the race to debut generic competition to Neurocrine Biosciences’ Ingrezza (valbenazine) treatment for tardive dyskinesia in the US, after both companies in quick succession penned patent-litigation settlements.
Picking up the right to launch its proposed generic beginning 1 March 2038, Lupin faces a 14-year wait to launch...
As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.
Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.
Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.
