Amicus Therapeutics resolved a patent dispute with Teva on Thursday, allowing Teva to launch a generic version of its Fabry disease treatment Galafold in 2037.
Leerink Partners analysts called it a “near best-case outcome” for Amicus, considering some Galafold patents begin to expire in the late 2020s. Amicus’ stock $FOLD was up nearly 15% on Thursday afternoon following the announcement.
Galafold, also known as migalastat, was approved in 2018 for Fabry disease, a rare genetic disorder that can lead to kidney and heart failure. The drug generated $387.8 million in 2023, up 18% from 2022. In court documents, Amicus has called it the “cornerstone” of its portfolio.
Amicus announced on Thursday that it will grant Teva a license to market generic Galafold in the US on Jan. 30, 2037, pending FDA approval. The deal will settle ongoing Galafold patent litigation between the companies in Delaware federal court, first filed in 2022. The license agreement is subject to review by the FTC and DOJ.
Sébastien Martel“This potentially provides the company with another 10+ years of exclusivity in the US for Galafold, which continues to launch well and is on track for >$450M in sales this year,” Leerink analysts said in a note to investors on Thursday.
On its most recent earnings call, Amicus touted Galafold’s 61 patents listed in the FDA’s Orange Book. CBO Sébastien Martel said Amicus was “confident that with our strong IP protection, Galafold has a long runway well into the next decade,” according to an AlphaSense transcript.
The settlement doesn’t resolve patent litigation against Aurobindo, which remains ongoing, and a stay will remain in place in litigation against Lupin.