FDA Orange Book
Is there a generic for Jelmyto?
Jelmyto contains mitomycin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Jelmyto (mitomycin). The Orange Book shows its last listed patent expires January 20, 2031 and its last listed exclusivity ends April 15, 2027.
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Jelmyto products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, pyelocalyceal | 40MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 211728, held by UROGEN PHARMA LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Jelmyto patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12268745 | January 20, 2031 | Method of use | U-4172 | 211728 |
| 9950069 | January 20, 2031 | Drug product | None | 211728 |
| 9040074 | January 20, 2031 | Drug product | None | 211728 |
Jelmyto exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-289 | Orphan drug exclusivity | April 15, 2027 | 211728 |
Questions
Is there a generic for Jelmyto?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Jelmyto (mitomycin). The Orange Book shows its last listed patent expires January 20, 2031 and its last listed exclusivity ends April 15, 2027.
What is the generic name for Jelmyto?
The active ingredient in Jelmyto is mitomycin, per the FDA Orange Book.
When does the Jelmyto patent expire?
The last patent listed for Jelmyto in the Orange Book expires January 20, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.