Natco Pharma gets tentative US FDA approval for olaparib generic

Business Jul 20, 2026

Big news for Natco Pharma: its generic version of Olaparib, a cancer drug, just got tentative approval from the US Food and Drug Administration.

The tablets match AstraZeneca's Lynparza and come in 100 mg and 150 mg doses.

After the announcement, Natco's shares jumped over 4% during the day, ending at ₹950.55.

Alembic to handle Olaparib US distribution

Natco will make the tablets, while Alembic Pharmaceuticals handles US distribution.

Olaparib had estimated US sales of about $1.4 billion for the 12 months ending March 2026, a huge opportunity for both companies.

Natco also mentioned that patent-related Paragraph IV litigation is still ongoing, so there are more legal matters to sort out before full launch.