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JIDEYTRO

NDA

ZIDESAMTINIB | N220185 | NUVALENT INC

2 strengths4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2027

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Today

May. 5, 2041

Sep. 30, 2042

May. 5, 2041

Sep. 30, 2042

NCE

Jul. 22, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)NCT05118789	Phase 1/2	Recruiting	Nuvalent Inc.	359	2022-01-04 → 2028-12-31
Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors NCT06797362	—	AVAILABLE	Nuvalent Inc.	—	—

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 24, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MG

RLD

4 patents1 exclusivity▴

TABLET;ORAL | Approved: Jul 22, 2026

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11542278	May 5, 2041	—	Yes	Yes	—	—
12043626	Sep 30, 2042	—	Yes	Yes	—	—
12054498	May 5, 2041	—	—	—		—
12630560	Sep 30, 2042	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Jul 22, 2031	Active

#002 — 100MG

RLD

4 patents1 exclusivity▾

TABLET;ORAL | Approved: Jul 22, 2026