Viewing data from:

RASONQUE

NDA

DARAXONRASIB | N220910 | REVOLUTION MEDICINES INC

2 strengths0 unique patents0 unique exclusivities

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 — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors NCT06128551	Phase 1/2	Recruiting	Revolution Medicines, Inc.	534	2023-11-14 → 2029-06
Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)NCT07252232	Phase 3	Recruiting	Revolution Medicines, Inc.	500	2025-12-15 → 2030-07-10

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 28, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 26, 2026

No patent or exclusivity listings for this strength.

#002 — 150MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 26, 2026

Change History (2)

Recent changes detected for this application.

ADDED10/19/2026

RASONQUE (daraxonrasib) by Revolution Medicines gained new chemical entity exclusivity expiring Aug 2031.

New: RASONQUE (DARAXONRASIB) — exclusivity NCE exp 08/26/2031

ADDED10/19/2026

RASONQUE (daraxonrasib) gained new chemical entity exclusivity expiring Aug 2031, blocking generic competition and 505(b)(2) applications during this period.

New: RASONQUE (DARAXONRASIB) — exclusivity NCE exp 08/26/2031