Amicus Therapeutics Grants Aurobindo, Lupin Licenses to Market Generic Galafold in the U.S. from 2037

In a strategic development for the rare disease treatment market, Amicus Therapeutics announced that it has entered into license agreements with Aurobindo Pharma and Lupin Ltd. The deal grants both Indian pharmaceutical companies rights to commercialize generic versions of Galafold 123 mg capsules in the United States, effective January 30, 2037.

Galafold, a key drug for treating Fabry disease, is currently marketed exclusively by Amicus and represents a significant therapy in the genetic disorders segment. The long-term licensing arrangement indicates Amicus’ proactive approach to managing patent expirations while ensuring future market access for affordable generics.

Key Highlights:

Drug involved: Galafold (migalastat) 123 mg capsules.

Licensee companies: Aurobindo Pharma Ltd. and Lupin Ltd.

Geographic scope: United States.

Effective generic entry date: January 30, 2037.

Strategic impact: Secures future generic rights while maintaining Amicus’ control over the market for the next decade.

Therapeutic area: Rare disease (Fabry disease).

Source: Amicus Therapeutics, Aurobindo Pharma