# JELMYTO — FDA application NDA211728

Informational only - not investment advice.

Application NDA211728 · type NDA · FDA status: approved · original approval 2020-04-15

Listed sponsor: UROGEN PHARMA · [URGN company profile](/company/URGN/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | JELMYTO | MITOMYCIN | POWDER | PYELOCALYCEAL | 40MG/VIAL | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 12268745, product 001; listed patent expiry date: 2031-01-20.
- Patent 9040074, product 001; listed patent expiry date: 2031-01-20.
- Patent 9950069, product 001; listed patent expiry date: 2031-01-20.
- Exclusivity ODE-289, product 001; listed exclusivity date: 2027-04-15.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- MITOMYCIN · UNII not resolved · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/URGN/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA211728. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.