Viewing data from:

KRAZATI

NDA

ADAGRASIB | N216340 | BRISTOL MYERS SQUIBB CO

1 strength4 unique patents2 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

2044

Today

May. 17, 2037

Sep. 10, 2041

Feb. 5, 2041

Aug. 21, 2043

NCE

Dec. 12, 2027

ODE-352

Dec. 12, 2029

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

4 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status NCT05673187	Phase 2	Active	ETOP IBCSG Partners Foundation	68	2023-06-12 → 2026-07
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors NCT06764771	Phase 1	Recruiting	Bristol-Myers Squibb	437	2025-03-25 → 2027-10-15
A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations NCT06412198	Phase 1/2	Recruiting	M.D. Anderson Cancer Center	31	2024-08-28 → 2029-03-01
Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients NCT05375994	Phase 1/2	Completed	Verastem, Inc.	12	2022-08-01 → 2026-06-15

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

Medicare Part D Spending

CMS annual spending data for Krazati (2023)

Total Spending

$22.7M

Total Claims

1,224

Beneficiaries

443

Avg Cost/Unit

$116.86

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 27, 2026	SUPPL -9	View Letter (PDF)
Jul 18, 2024	SUPPL -5	View Letter (PDF)
Dec 13, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

RLD

4 patents2 exclusivities▴

TABLET;ORAL | Approved: Dec 12, 2022

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10689377	May 17, 2037	—	Yes	Yes		—
12281113	Sep 10, 2041	—	Yes	Yes	—	—
12336995	Feb 5, 2041	—	—	—		—
12383503	Aug 21, 2043	—	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
NCE	Dec 12, 2027	Active
ODE-352	Dec 12, 2029	Active