Home / Generic availability / Romidepsin
When will generic Romidepsin be available?
Based on the patents and exclusivity the FDA lists today, generic romidepsin cannot be marketed in the United States before 2026-12-07, when the last listed protection expires.
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| CGT | 2026-12-07 | Competitive generic therapy (180 days) | ROMIDEPSIN |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| ISTODAX | Brand (NDA) | BRISTOL-MYERS SQUIBB CO | 2009-11-05 | reference listed drug, reference standard |
| ROMIDEPSIN | Generic (ANDA) | FRESENIUS KABI USA LLC | 2021-10-12 | |
| ROMIDEPSIN | Brand (NDA) | TEVA PHARMACEUTICALS USA INC | 2020-03-13 | reference listed drug |
| ROMIDEPSIN | Generic (ANDA) | AMNEAL EU LTD | 2026-06-02 | reference standard |
What a generic Romidepsin would have to match
Forms and strengths
For Injection: 10 mg of romidepsin as a lyophilized white powder in a single-dose vial for reconstitution and further dilution. For injection: 10 mg of romidepsin as a lyophilized powder in single-dose vial for reconstitution ( 3 ).
How it is supplied
How Supplied Romidepsin for injection is supplied as a kit including a sterile, lyophilized powder in a 10 mg single-dose vial containing 11 mg of romidepsin, 22 mg of the bulking agent, povidone, USP, and hydrochloric acid, NF, as a pH adjuster. In addition, each kit includes a single-dose sterile vial with 2.2 mL deliverable volume of the diluent composed of 80% propylene glycol, USP, and 20% dehydrated alcohol, USP. Product No. NDC No. 704928 63323-926-88 Romidepsin Kit containing 1 vial of romidepsin and 1 vial of diluent for romidepsin per carton. Storage and Handling Romidepsin for injection is supplied as a kit containing 2 vials in a single carton. The carton must be stored at 20° to...
Storage
Storage and Handling Romidepsin for injection is supplied as a kit containing 2 vials in a single carton. The carton must be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Romidepsin is a hazardous drug. Follow applicable special handling and disposal procedures. 1 The container closure is not made with natural rubber latex.
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-04-29.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Pasireotideprotection runs to December 2026
- Leuprolideprotection runs to January 2027
- Carfilzomibprotection runs to January 2027
- Exenatideprotection runs to February 2027
- Linaclotideprotection runs to February 2027
Frequently asked questions
When will generic Romidepsin be available?
Based on the patents and exclusivity the FDA lists today, generic romidepsin cannot be marketed in the United States before 2026-12-07, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-11-01. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.
Related data
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book