Mumbai-based Lupin Limited has announced that its Abbreviated New Drug Application (ANDA) for Ivacaftor Oral Granules has received tentative approval from the US Food and Drug Administration (USFDA). The drug is a generic equivalent of Vertex Pharmaceuticals’ Kalydeco Oral Granules and is indicated for treating cystic fibrosis (CF).

Key Highlights:

• FDA Tentative Approval:

The USFDA granted tentative approval to Ivacaftor Oral Granules in dosage strengths of 25 mg, 50 mg, and 75 mg.

• Treatment Indication:

The drug is indicated for cystic fibrosis patients aged 4 months and older with at least one mutation in the CFTR gene responsive to ivacaftor.

• First-to-File Exclusivity:

Lupin claims to be the exclusive first-to-file applicant for this product, potentially qualifying for 180 days of generic drug exclusivity in the US market.

• Manufacturing Location:

The generic version of Ivacaftor Oral Granules will be manufactured at Lupin’s Nagpur facility in India.

• Market Potential:

The branded version, Kalydeco, generated an estimated $51 million in the US market in the 12 months ending November 2024.

Statements from Leaders or Officials:
A Lupin spokesperson noted, "This approval highlights Lupin’s commitment to addressing critical therapeutic areas like cystic fibrosis. We are proud to leverage our manufacturing expertise at our Nagpur facility to bring this important treatment option to market.”With tentative approval in hand, Lupin awaits final FDA approval to begin marketing the drug in the US. If the exclusivity period is granted, it could significantly strengthen Lupin’s position in the US generic drug market while providing a cost-effective alternative for cystic fibrosis patients.