Adagrasib Patent Expiration

Adagrasib is Used for treating locally advanced or metastatic non-small cell lung cancer in adult patients with a specific KRAS mutation who have already undergone prior systemic therapy. It was first introduced by Bristol Myers Squibb Co in its drug Krazati on Dec 12, 2022.


Adagrasib Patents

Given below is the list of patents protecting Adagrasib, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Krazati US12383503 Adagrasib Solid Pharmaceutical Compositions Aug 21, 2043 Bristol
Krazati US12653789 Adagrasib Solid Pharmaceutical Compositions Aug 21, 2043 Bristol
Krazati US12281113 Crystalline forms of a KRas G12C inhibitor Sep 10, 2041 Bristol
Krazati US12336995 Combination Therapies Feb 05, 2041 Bristol
Krazati US10689377 KRas G12C inhibitors May 17, 2037 Bristol



Adagrasib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Adagrasib:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7 Mirati Therapeutics Inc. NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status ETOP IBCSG Partners Foundation NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation Incyte Corporation NA TERMINATED
(Sep 1, 2026)
PHASE1
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4) Mirati Therapeutics Inc. NA RECRUITING
(Sep 1, 2026)
PHASE3
A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies Mirati Therapeutics Inc. NA RECRUITING
(Sep 1, 2026)
PHASE2
CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer Roswell Park Cancer Institute NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21) Mirati Therapeutics Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Single-dose Adagrasib (BMS-986503) in Healthy Participants of Japanese Descent Mirati Therapeutics Inc. NA RECRUITING
(Aug 1, 2026)
PHASE1
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1 Mirati Therapeutics Inc. NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation Mirati Therapeutics Inc. NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation Mirati Therapeutics Inc. NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations M.D. Anderson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers M.D. Anderson Cancer Center NA TERMINATED
(Apr 1, 2026)
PHASE1
Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases Ryan Gentzler, MD NA RECRUITING
(Apr 1, 2026)
PHASE2
Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial City of Hope Medical Center NA RECRUITING
(Apr 1, 2026)
PHASE2


Adagrasib Generic API Manufacturers

Given below is the list of companies who have filed for Adagrasib generic, along with the locations of their manufacturing plants worldwide.