Alembic Pharmaceuticals wins tentative FDA approval for generic Vitrakvi (larotrectinib)
Business
Alembic Pharmaceuticals just got a tentative thumbs-up from the US Food and Drug Administration for its generic version of Bayer's Vitrakvi Capsules.
Their Larotrectinib Capsules help treat tough solid tumors with NTRK gene fusion, in both adults and kids, especially when other treatments haven't worked or surgery isn't an option.
Alembic could get 180-day US exclusivity
Alembic might score 180 days of exclusive marketing in the US if final approval comes through, since it was first to file under Hatch-Waxman rules.
The original drug pulled in $91 million in US sales for the 12 months ended March 2026, so this is big.
With this win, Alembic now has 241 FDA approvals (including 20 tentative ones), and its stock was trading 0.8% higher on Thursday at ₹743.5.