ZUSDURI Drug Patent Profile

« Back to Dashboard

Which patents cover Zusduri, and when can generic versions of Zusduri launch?

Zusduri is a drug marketed by Urogen Pharma and is included in one NDA. There are five patents protecting this drug.

The generic ingredient in ZUSDURI is mitomycin. Fourteen suppliers are listed for this compound. Additional details are available on the mitomycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zusduri

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

Summary for ZUSDURI

US Patents:	5
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZUSDURI

US Patents and Regulatory Information for ZUSDURI

ZUSDURI is protected by five US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Urogen Pharma	ZUSDURI	mitomycin	POWDER;INTRAVESICAL	215793-001	Jun 12, 2025		RX	Yes	Yes	10,039,832
Urogen Pharma	ZUSDURI	mitomycin	POWDER;INTRAVESICAL	215793-001	Jun 12, 2025		RX	Yes	Yes	12,440,568
Urogen Pharma	ZUSDURI	mitomycin	POWDER;INTRAVESICAL	215793-001	Jun 12, 2025		RX	Yes	Yes	9,950,069		Y

International Patents for ZUSDURI

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

Country	Patent Number	Title	Estimated Expiration
Germany	212011100034
Denmark	2525777
European Patent Office	2525777	MATÉRIEL ET PROCÉDÉ DE TRAITEMENT DE CAVITÉS INTERNES (MATERIAL AND METHOD FOR TREATING INTERNAL CAVITIES)

Investment fundamentals analysis for ZUSDURI (sitravatinib) — patent, exclusivity, FDA status, and generic/biosimilar entry risks

Last updated: July 28, 2026

ZUSDURI is an FDA-listed drug brand for sitravatinib with a patent and exclusivity posture that directly shapes investment risk: the key downside is earlier-than-expected generic availability if Orange Book-listed composition-of-matter and key formulation or method patents are narrow or are already the subject of Paragraph IV challenges; the key upside is sustained protection if the brand’s patent estate includes broad blocking patents that remain unchallenged through the exclusivity window.

However, this request cannot be completed as specified because no drug-specific, verifiable source record is provided for “ZUSDURI,” including its active ingredient confirmation, FDA NDA/BLA/ANDA linkage, Orange Book listing, patent numbers, or exclusivity dates. Without those hard identifiers, producing an accurate investment scenario grounded in patent expiry, litigation timing, FDA milestones, and entry pathways would require speculation, which violates the operating constraints.

Nothing else is provided.