JELMYTO — FDA application NDA211728

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

Listed sponsor: UROGEN PHARMA · URGN company profile · 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

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Listing	Product	Descriptive date	Flags/code
Patent 12268745	001	listed patent expiry date: 2031-01-20	U-4172
Patent 9040074	001	listed patent expiry date: 2031-01-20	drug product
Patent 9950069	001	listed patent expiry date: 2031-01-20	drug product
Exclusivity ODE-289	001	listed exclusivity date: 2027-04-15	FDA code as listed

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

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

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

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