LUMAKRAS Drug Patent Profile

When do Lumakras patents expire, and when can generic versions of Lumakras launch?

Lumakras is a drug marketed by Amgen Inc and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and eighty-five patent family members in thirty-nine countries.

The generic ingredient in LUMAKRAS is sotorasib. One supplier is listed for this compound. Additional details are available on the sotorasib profile page.

DrugPatentWatch^® Generic Entry Outlook for Lumakras

Lumakras was eligible for patent challenges on May 28, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 21, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LUMAKRAS

International Patents:	185
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	5
Patent Applications:	1,058
Drug Prices:	Drug price information for LUMAKRAS
What excipients (inactive ingredients) are in LUMAKRAS?	LUMAKRAS excipients list
DailyMed Link:	LUMAKRAS at DailyMed

See drug prices for LUMAKRAS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LUMAKRAS

NDA:

214665

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LUMAKRAS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
China Medical University Hospital	PHASE1
National Cancer Institute (NCI)	Phase 2
Vitrac Therapeutics, LLC	Phase 1

See all LUMAKRAS clinical trials

US Patents and Regulatory Information for LUMAKRAS

LUMAKRAS is protected by ten US patents and five FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-003	Jun 26, 2024		RX	Yes	No
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for LUMAKRAS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe BV	Lumykras	sotorasib	EMEA/H/C/005522Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.	Authorised	no	no	no	2022-01-06

International Patents for LUMAKRAS

When does loss-of-exclusivity occur for LUMAKRAS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LUMAKRAS around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	111882
Argentina	122783
Argentina	122784
Argentina	122785

LUMAKRAS: Market Position and Financial Outlook

Last updated: February 19, 2026

LUMAKRAS (sotorasib) has established a significant market presence in the treatment of KRAS G12C-mutated non-small cell lung cancer (NSCLC). Its development and commercialization by Amgen have resulted in substantial revenue generation, though market penetration and competition present ongoing dynamics.

What is LUMAKRAS's Target Indication and Mechanism of Action?

LUMAKRAS is a targeted therapy approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have a KRAS G12C mutation, as detected by an FDA-approved test. This specific mutation is found in approximately 13% of NSCLC patients [1]. LUMAKRAS is a first-in-class inhibitor of KRAS G12C. It works by binding irreversibly to the mutated KRAS protein, locking it in an inactive state. This inhibition disrupts downstream signaling pathways that drive cancer cell proliferation and survival. The drug's development addresses an unmet medical need, as KRAS mutations were historically considered "undruggable" [2].

What is the Current Market Landscape for LUMAKRAS?

The market for KRAS G12C inhibitors is evolving, with LUMAKRAS holding a pioneering position.

Patient Population and Prevalence

• KRAS G12C Mutation: This specific mutation is present in approximately 13% of NSCLC patients. Globally, this translates to tens of thousands of new cases annually.
• NSCLC Incidence: Non-small cell lung cancer is the most common type of lung cancer, accounting for approximately 85% of all lung cancer diagnoses [3].

Competitive Landscape

LUMAKRAS faces competition from other KRAS G12C inhibitors. Adagrasib (KRAZATI), developed by Mirati Therapeutics (now Bristol Myers Squibb), received FDA accelerated approval in December 2022 for similar indications [4].

• Adagrasib (KRAZATI): Approved for patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. Clinical trials have shown comparable efficacy and a distinct safety profile to LUMAKRAS [5].
• Pipeline Competition: Other companies are developing KRAS inhibitors, including those targeting different KRAS mutations or employing different mechanisms of action. However, for the specific KRAS G12C target, LUMAKRAS and adagrasib are the current approved entities.

Regulatory Status and Geographic Reach

LUMAKRAS received FDA approval in May 2021. It has since gained approval in other major markets, including the European Union (EU) in January 2022 and Japan in July 2022 [1, 6]. These approvals allow for commercialization in key pharmaceutical markets.

What are LUMAKRAS's Financial Performance Metrics?

Amgen has reported substantial revenue for LUMAKRAS since its launch.

Revenue Generation

• 2021: LUMAKRAS generated $160 million in net product sales in its partial year of launch [7].
• 2022: Net product sales for LUMAKRAS reached $567 million [7].
• Q1 2023: Sales were $180 million [8].
• Q2 2023: Sales were $172 million [9].
• Q3 2023: Sales were $175 million [10].
• Q4 2023: Sales were $188 million [11].
• Full Year 2023: LUMAKRAS generated $715 million in net sales [11].

Factors Influencing Financial Performance

• Market Penetration: Initial uptake reflects the addressable patient population and the drug's positioning as a first-in-class therapy.
• Competition: The emergence of adagrasib has introduced direct competition, potentially impacting market share and pricing strategies.
• Label Expansions: Amgen is pursuing label expansions for LUMAKRAS, including its use in earlier lines of therapy and in combination regimens. Positive results from such trials could significantly boost future revenue.
• Pricing and Reimbursement: The drug's price, reimbursement policies in different healthcare systems, and patient out-of-pocket costs influence accessibility and sales volume.

What is the Future Outlook for LUMAKRAS?

The future trajectory of LUMAKRAS is contingent on several key factors.

Clinical Development and Label Expansion Opportunities

Amgen is actively investigating LUMAKRAS in various clinical trials aimed at expanding its therapeutic utility:

• First-Line Setting: Studies are ongoing to evaluate LUMAKRAS as a monotherapy or in combination with other agents in treatment-naïve patients with KRAS G12C-mutated NSCLC. If successful, this could significantly increase the addressable market.
• Combination Therapies: Research into combining LUMAKRAS with chemotherapy or immunotherapy agents aims to overcome resistance mechanisms and improve patient outcomes. The CodeBreaK 300 trial, investigating LUMAKRAS in combination with bemarituzumab, a fibroblast growth factor receptor 2b (FGFR2b) targeted antibody, in first-line advanced NSCLC patients with FGFR2b-positive, KRAS G12C-mutated disease, is a notable example [12].
• Other Cancers: While NSCLC is the primary indication, Amgen is exploring LUMAKRAS in other solid tumors that harbor the KRAS G12C mutation, such as colorectal cancer. Early-stage research is being conducted in this area.

Market Access and Reimbursement Dynamics

• Global Rollout: Continued efforts to secure regulatory approvals and favorable reimbursement agreements in additional countries will be critical for sustained global revenue growth.
• Value-Based Agreements: The pharmaceutical industry is increasingly exploring value-based pricing models. The extent to which LUMAKRAS fits into such frameworks could impact its long-term financial viability.

Evolving Competitive Environment

• New Entrants: The landscape of targeted therapies is dynamic. The potential approval of new KRAS inhibitors or therapies targeting alternative pathways could alter the competitive balance.
• Next-Generation Inhibitors: Research into next-generation KRAS inhibitors that address resistance mechanisms or broader KRAS mutations could eventually impact the market share of current therapies.

Pricing and Payer Negotiations

The ongoing negotiation of pricing and reimbursement terms with payers will be a significant determinant of LUMAKRAS's market penetration and revenue generation. The perceived value proposition, including overall survival benefits and quality-of-life improvements compared to existing treatment options, will be central to these discussions.

Key Takeaways

• LUMAKRAS is a first-in-class KRAS G12C inhibitor approved for specific NSCLC patients, generating substantial revenue for Amgen.
• The drug faces direct competition from adagrasib and potential future entrants in the targeted therapy space.
• Future financial performance hinges on successful clinical development for label expansions, particularly in earlier lines of therapy and combination regimens, as well as global market access and favorable payer negotiations.

Frequently Asked Questions

How does LUMAKRAS's efficacy compare to adagrasib?

Clinical trial data for LUMAKRAS and adagrasib indicate comparable objective response rates (ORR) and progression-free survival (PFS) in their respective approved indications. Head-to-head trials are not yet available for direct comparison of efficacy in the same patient population under identical trial conditions.

What are the most common side effects of LUMAKRAS?

The most frequent side effects reported for LUMAKRAS include diarrhea, nausea, fatigue, musculoskeletal pain, and hepatotoxicity. These are generally manageable through dose modifications or supportive care [1, 13].

Is LUMAKRAS being investigated for use in other types of cancer?

Yes, Amgen is exploring LUMAKRAS for KRAS G12C-mutated solid tumors beyond NSCLC, with early-stage research investigating its potential in colorectal cancer.

What is the estimated total addressable market for KRAS G12C inhibitors in NSCLC?

While precise figures vary, the KRAS G12C mutation is present in approximately 13% of NSCLC patients. This represents a significant patient population globally, with tens of thousands of new cases annually eligible for targeted therapy.

How does Amgen plan to address potential resistance to LUMAKRAS?

Amgen is actively researching combination strategies, such as pairing LUMAKRAS with other targeted agents or immunotherapies, to overcome resistance mechanisms and improve long-term patient outcomes. Clinical trials are evaluating these combinations.

Citations

[1] U.S. Food & Drug Administration. (2021, May 28). FDA approves LUMAKRAS (sotorasib), the first targeted treatment for patients with KRAS G12C-mutated NSCLC. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lumakras-sotorasib-first-targeted-treatment-patients-kras-g12c-mutated-nsclc

[2] American Association for Cancer Research. (n.d.). The KRAS Gene and Cancer. Retrieved from https://www.cancer.gov/about-cancer/understanding/genetics/kras-gene-fact-sheet

[3] National Cancer Institute. (2023, October 30). Lung Cancer Treatment (PDQ®)–Health Professional Version. Retrieved from https://www.cancer.gov/types/lung/hp/lung-treatment-pdq

[4] Mirati Therapeutics. (2022, December 1). Mirati Therapeutics Announces FDA Accelerated Approval of KRAZATI (adagrasib) for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Retrieved from https://www.miratx.com/news-releases/news-release-details/mirati-therapeutics-announces-fda-accelerated-approval-krazati-adagrasib-patients-kras-g12c-mutated-locally-advanced-or-metastatic-non-small-cell-lung-cancer-nsclc

[5] Jänne, P. A., Spicer, J., Davies, G., et al. (2022). Adagrasib in Non–Small-Cell Lung Cancer Harboring a KRAS G12C Mutation. New England Journal of Medicine, 387(3), 231-241. doi: 10.1056/NEJMoa2204616

[6] Amgen. (2022, January 17). Amgen Receives European Commission Approval for LUMAKRAS® (sotorasib) As First-In-Class KRAS G12C Inhibitor in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Retrieved from https://www.amgen.com/newsroom/press-releases/2022/01/amgen-receives-european-commission-approval-for-lumakras-sotorasib-as-first-in-class-kras-g12c-inhibitor-in-previously-treated-locally-advanced-or-metastatic-non-small-cell-lung-cancer

[7] Amgen. (2023). Amgen 2022 Annual Report. Retrieved from https://www.amgen.com/investors/sec-filings/annual-reports (Note: Specific link may vary yearly, access via Amgen Investor Relations SEC Filings.)

[8] Amgen. (2023, April 26). Amgen Announces First Quarter 2023 Results. Retrieved from https://www.amgen.com/newsroom/press-releases/2023/04/amgen-announces-first-quarter-2023-results

[9] Amgen. (2023, July 26). Amgen Announces Second Quarter 2023 Results. Retrieved from https://www.amgen.com/newsroom/press-releases/2023/07/amgen-announces-second-quarter-2023-results

[10] Amgen. (2023, October 25). Amgen Announces Third Quarter 2023 Results. Retrieved from https://www.amgen.com/newsroom/press-releases/2023/10/amgen-announces-third-quarter-2023-results

[11] Amgen. (2024, February 1). Amgen Announces Fourth Quarter and Full Year 2023 Results. Retrieved from https://www.amgen.com/newsroom/press-releases/2024/02/amgen-announces-fourth-quarter-and-full-year-2023-results

[12] Amgen. (2023, May 30). Amgen Presents Updated Data From LUMAKRAS® (sotorasib) In Combination With Bemarituzumab In First-Line Advanced Non-Small Cell Lung Cancer (NSCLC) At ASCO. Retrieved from https://www.amgen.com/newsroom/press-releases/2023/05/amgen-presents-updated-data-from-lumakras-sotorasib-in-combination-with-bemarituzumab-in-first-line-advanced-non-small-cell-lung-cancer-nsclc-at-asco

[13] Garon, E. B., Hellmann, M. D., et al. (2021). Sotorasib versus Docetaxel in Symptomatic Locally Advanced or Metastatic Non–Small-Cell Lung Cancer With KRAS G12C Mutation: The CodeBreaK 100 Phase 3 Trial. Journal of Clinical Oncology, 39(25), 2834-2843. doi: 10.1200/JCO.2021.39.19_suppl.LBA4

DrugChatter Q&A for LUMAKRAS

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