JELMYTO Drug Patent Profile

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Which patents cover Jelmyto, and what generic alternatives are available?

Jelmyto is a drug marketed by Urogen Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in six countries.

The generic ingredient in JELMYTO is mitomycin. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mitomycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jelmyto

A generic version of JELMYTO was approved as mitomycin by HIKMA on April 19^th, 1995.

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Summary for JELMYTO

International Patents:	9
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	4,558
Drug Prices:	Drug price information for JELMYTO
What excipients (inactive ingredients) are in JELMYTO?	JELMYTO excipients list
DailyMed Link:	JELMYTO at DailyMed

Drug patent expirations by year for JELMYTO

Recent Clinical Trials for JELMYTO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
City of Hope Medical Center	Phase 2
Mayo Clinic	Phase 2
National Cancer Institute (NCI)	Phase 2

See all JELMYTO clinical trials

Paragraph IV (Patent) Challenges for JELMYTO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JELMYTO	Powder for Injection	mitomycin	40 mg/vial	211728	1	2023-12-28

US Patents and Regulatory Information for JELMYTO

JELMYTO is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting JELMYTO

Material and method for treating internal cavities
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting JELMYTO

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH LOW-GRADE UPPER TRACT UROTHELIAL CANCER (LG-UTUC)
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for JELMYTO

See the table below for patents covering JELMYTO around the world.

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Country	Patent Number	Title	Estimated Expiration
Israel	230530	חומרים ושיטה לטיפול בחללים של הגוף (Materials and method for treating internal body cavities)	⤷ Sign Up
Israel	221040	חומר ושיטה לטיפול בחללי גוף פנימיים (Material and method for treating internal cavities)	⤷ Sign Up
Denmark	2525777		⤷ Sign Up
Spain	2732150		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration