Gilead Sciences, after striking a similar deal in 2014 to delay generics of its earlier HIV pre-exposure prophylaxis (PrEP) med Truvada, has followed suit on its key next-gen offering Descovy.
Monday, Gilead said it has reached an accord with five copycat drugmakers—Lupin, Apotex, Macleods, Hetero Labs and Cipla—resolving lawsuits and patent feuds around Descovy, plus hepatitis B drug Vemlidy and Gilead’s HIV treatment Odefsey.
All three meds are underpinned by Gilead’s molecule tenofovir alafenamide.
The deal adds clarity around the financial future of the trio of Gilead drugs. Meanwhile, such patent settlements aren’t uncommon for Gilead—or Indian generics giant Cipla, for that matter—at times inviting legal scrutiny and industry-watcher flak.
Monday's deal paves the way for the copycat quintet to roll out Descovy and Vemlidy generics starting Halloween of 2031, while Odefsey copycats can launch beginning January 31, 2032, Gilead said in a securities filing (PDF) Monday.
The generic drugmakers may receive licenses on the trio of Gilead meds in the U.S. earlier “in certain circumstances,” Gilead pointed out, without disclosing specifics.
The outcome gives Gilead’s antiviral triumvirate some notable breathing room. The threat of Descovy, Vemlidy and Odefsey generics previously loomed as early as 2025, according to consensus Wall Street predictions, Mizuho Securities analysts wrote in a note to clients Monday.
Gilead recently inked similar pacts around its tenofovir alafenamide patents with other generics outfits Shilpa, Sunshine Lake and Natco, the analysts noted.
Now, the fact that Gilead has staved off generic entry from so many drugmakers and stalled Descovy, Vemlidy and Odefsey’s losses of exclusivity into the next decade “bodes well for any future challenges,” the Mizuho team added.
The move isn’t unfamiliar for Gilead, meanwhile, which previously inked similar deals on Emtriva, Atripla and Truvada before certain patent expirations. Atripla and Truvada generics eventually graced the U.S. market in October 2020, while Emtriva generics rolled out in August of that same year.
Last month, meanwhile, a California judge ruled that Gilead must contend with a lawsuit alleging anticompetitive conduct tied to the 2014 patent settlement with Cipla.
All told, Gilead’s roster of tenofovir alafenamide-based products, which also includes the likes of Biktarvy and Genvoya, brought home $15.30 billion for all of 2021, Gilead said in its 2021 earnings report published n February.
The company’s Truvada stable, which includes Atripla, Complera and other meds, pulled down $936 million over the same 12-month stretch.