Sotorasib Patent Expiration

Sotorasib is Used for treating adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least one prior systemic therapy. It was first introduced by Amgen Inc in its drug Lumakras on May 28, 2021.


Sotorasib Patents

Given below is the list of patents protecting Sotorasib, 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
Lumakras US11426404 Dosing of KRAS inhibitor for treatment of cancers Sep 15, 2040 Amgen Inc
Lumakras US11236091 Solid state forms May 20, 2040 Amgen Inc
Lumakras US11827635 Solid state forms May 20, 2040 Amgen Inc
Lumakras US12398133 Solid State Forms May 20, 2040 Amgen Inc
Lumakras US12280056 Combination therapy including a KRASG12C inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers Nov 18, 2039 Amgen Inc
Lumakras US10519146 KRAS G12C inhibitors and methods of using the same May 21, 2038 Amgen Inc



Sotorasib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Sotorasib:

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
A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation Bayer NA RECRUITING
(Sep 22, 2026)
PHASE1
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) Gruppo Oncologico del Nord-Ovest NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study of Sotorasib in People With Non-Small Cell Lung Cancer Memorial Sloan Kettering Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE2
Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation National Cancer Institute (NCI) NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) Memorial Sloan Kettering Cancer Center NA TERMINATED
(Aug 1, 2026)
PHASE2
A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation Amgen NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment Amgen NA TERMINATED
(Jun 1, 2026)
PHASE2
A Study of Sotorasib in People With Brain Tumors Memorial Sloan Kettering Cancer Center NA RECRUITING
(May 1, 2026)
PHASE1
A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors Ningbo Newbay Technology Development Co., Ltd NA TERMINATED
(Apr 1, 2026)
PHASE1
Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy Fundación GECP NA RECRUITING
(Apr 1, 2026)
PHASE2
Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors Vividion Therapeutics, Inc. NA RECRUITING
(Mar 1, 2026)
PHASE1


Sotorasib Generic API Manufacturers

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