Amneal’s 180-Day Romidepsin Approval Threatens Teva’s $78 Million Market
TEVA•Amneal Pharmaceuticals received FDA approval for a ready-to-use romidepsin injection, referencing Teva’s previously marketed formulation which was withdrawn several years ago. The 180-day exclusivity on a U.S. market worth about $78 million annually could pressure future sales if Teva reenters or competes in this segment.
1. Background on Teva’s Romidepsin Withdrawal
Teva originally marketed a lyophilized romidepsin powder formulation for lymphoma patients but withdrew the product from the U.S. market several years ago for strategic or operational reasons, leaving a gap in treatment preparation convenience.
2. Amneal Secures FDA Approval
Amneal obtained FDA clearance for a 27.5 mg/5.5 mL ready-to-use romidepsin injection solution, earning Competitive Generic Therapy designation and 180 days of market exclusivity, directly referencing the bioequivalence to Teva’s former product.
3. Implications for Teva
With U.S. sales of romidepsin powder products reaching approximately $78 million over the past 12 months, Teva faces renewed competition should it choose to relaunch or defend its position, potentially requiring pricing or formulation strategy adjustments.
