Viewing data from:

RASONQUE

NDA

DARAXONRASIB | N220910 | REVOLUTION MEDICINES INC

2 strengths2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2027

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2030

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2042

Today

12280113

Jan. 24, 2042

12403196

Sep. 15, 2041

NCE

Aug. 26, 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

6 trials from ClinicalTrials.gov — 6 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma NCT07805954	Phase 3	Recruiting	Revolution Medicines, Inc.	400	2026-08-28 → 2030-04
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)NCT06881784	Phase 3	Recruiting	Revolution Medicines, Inc.	590	2025-05-06 → 2030-12-01
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
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma NCT07491445	Phase 3	Recruiting	Revolution Medicines, Inc.	900	2026-03-09 → 2029-03
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)NCT07492680	Phase 2	Recruiting	Bristol-Myers Squibb	260	2026-07-27 → 2032-05-20

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

2 patents1 exclusivity▴

TABLET;ORAL | Approved: Aug 26, 2026

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12280113Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Jan 24, 2042	—	Yes	Yes	—	—
12403196Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Sep 15, 2041	—	Yes	Yes	—	—

Exclusivities (1)

Code	Date	Status
NCENewly listed — daily FDA feed, not yet in monthly Orange Book edition	Aug 26, 2031	Active

#002 — 150MG

RLD

2 patents1 exclusivity▾

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