Amicus Therapeutics Settles Patent Lawsuit Teva Pharmaceuticals Over Generic Version Of Its Rare Genetic Disorder Drug

On Thursday, Amicus Therapeutics FOLD announced that it has entered into a License Agreement with Teva Pharmaceuticals Inc. TEVA.

The agreement resolves the patent litigation brought by Amicus in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Galafold (migalastat) 123mg capsules before the expiration of the applicable patents.

Also Read: Teva Pays $450M To Resolve Alleged Kickback, Price-Fixing Schemes.

Galafold is a medication for Fabry disease, a rare genetic disorder caused by the buildup of a type of fat called globotriaosylceramide in the body’s cells.

Under the terms of the Agreement, Amicus will grant Teva a license to market its generic version of Galafold in the United States beginning on January 30, 2037, if approved by the FDA and unless certain limited circumstances customarily included in these types of agreements occur.

The parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Teva regarding Galafold patents pending in the U.S. District Court for the District of Delaware.

The litigation will continue against Aurobindo as the remaining active party, and the litigation stay remains in place for Lupin.

Price Action: TEVA stock is up 0.47% at $18.11, and FOLD stock is up 12.4% at $11.81 at last check Thursday.

Image via Unsplash

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