Amneal Gains 180-Day Exclusivity on FDA-Approved Romidepsin Injection Solution
AMRX•FDA approved Amneal’s ready-to-use romidepsin injection solution, 27.5 mg/5.5 mL single-dose vials, earning Competitive Generic Therapy status for 180 days of U.S. market exclusivity. IQVIA reports U.S. annual sales for romidepsin lyophilized powder reached $78 million in the 12 months through April 2026, indicating significant market potential.
1. FDA Approval Details
Amneal secured FDA approval for its romidepsin injection solution, a 27.5 mg/5.5 mL pre-diluted, ready-to-use formulation supplied in single-dose vials. The product’s Competitive Generic Therapy designation grants Amneal 180 days of U.S. market exclusivity, supporting a faster launch with no direct generic competition.
2. Market and Sales Potential
U.S. annual sales for the prior lyophilized romidepsin powder reached approximately $78 million in the 12 months ended April 2026, highlighting strong demand. The ready-to-use format can drive faster adoption and higher hospital throughput, potentially capturing a significant share of existing romidepsin sales.
3. Strategic Impact
This approval strengthens Amneal’s injectables portfolio by adding an oncology treatment with high operational and safety advantages. It underscores the company’s leadership in complex injectables and aligns with its strategy to expand differentiated, high-value medicines supporting long-term growth and supply reliability.
