Teva Sues Amicus for Refusing to Share Galafold Supplies
Teva Pharmaceuticals has sued Amicus Therapeutics, alleging the company refused to supply samples of its high-priced branded drug, Galafold (migalastat), as required under federal law.
Teva, which is developing a generic of the treatment for Farbry disease, a rare genetic disorder, claims that Philadelphia-based Amicus delivered two initial packs of Galafold on April 27, more than six months after the deadline mandated by the 2019 CREATES Act, which includes measures intended to reduce prices and increase the competitiveness of generic drugs.
In its complaint filed in the U.S. District Court for the Eastern District of Pennsylvania., Teva also charged that the company denied a follow-up request and said it has been unable to conduct analytical and bioequivalence testing needed for an abbreviated new drug application.
Amicus won FDA approval for Galafold in August 2018. The drug, which costs $315,000 a year for a single patient, earned more than $261 million in 2020.