Lupin's Milestone: USFDA Approval for Generic Ivacaftor

Lupin Ltd received tentative approval from the USFDA for its generic version of Ivacaftor oral granules, used for treating cystic fibrosis. The product, produced at Lupin's Nagpur facility, may qualify for 180 days of exclusivity and has a potential USD 51 million annual sale in the US.

Lupin Ltd announced on Thursday a tentative nod from the USFDA to market its generic version of Ivacaftor oral granules, designed for cystic fibrosis treatment.

The US approval pertains to various strengths of the granules, equivalent to Vertex Pharmaceuticals' 'Kalydeco', highlighting Lupin's exclusive first-to-file standing for possible 180 days of market exclusivity. Produced in Nagpur, the granules target patients at or over four months old with CFTR gene mutation.

Quoting IQVIA MAT November 2024 data, Lupin noted the drug's projected USD 51 million annual sale potential in the US market.