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 sixty-eight patent family members in thirty-eight 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 20, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LUMAKRAS

International Patents:	168
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	5
Patent Applications:	867
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

Constraining patent/regulatory exclusivity:

11,236,091

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
Westat	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.

This potential generic entry date is based on patent 11,236,091.

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	12,280,056
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes	11,426,404
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No	11,426,404
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-003	Jun 26, 2024		RX	Yes	No	11,426,404
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-003	Jun 26, 2024		RX	Yes	No	10,519,146		Y	Y

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

European Patent Office

Israel

Japan

Jordan

Mexico

New Zealand

Peru

Philippines

Saudi Arabia

Singapore

South Korea

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
Morocco	55959
Brazil	112021023277
Singapore	11202112855W
European Patent Office	3974429
Japan	2021523216	固体形態
Taiwan	I824990
China	114144414	固态形式 (Solid state forms)

Market Dynamics and Financial Trajectory for LUMAKRAS (Kras) in Oncology Drug Market

Last updated: July 27, 2025

Introduction

LUMAKRAS (sotorasib), developed by Amgen, represents a significant breakthrough in targeted cancer therapy, specifically targeting KRAS G12C mutations responsible for a subset of non-small cell lung cancers (NSCLC). As the first FDA-approved KRAS G12C inhibitor, LUMAKRAS is poised to redefine the landscape of precision oncology. Analyzing its market dynamics and financial trajectory is pivotal for industry stakeholders aiming to forecast growth, competitive positioning, and investment potential.

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Market Overview and Therapeutic Indication Landscape

The global oncology market forecasts a compound annual growth rate (CAGR) of approximately 7.6% from 2022 to 2028, driven by rising cancer incidence, advances in targeted therapies, and personalized medicine adoption [1]. Within this broader context, LUMAKRAS targets KRAS G12C mutations, which account for roughly 13% of NSCLC cases globally. The prevalence of KRAS mutations extends to other solid tumors, including colorectal and pancreatic cancers, enhancing the drug’s expansion potential.

The FDA approval of LUMAKRAS in May 2021 was based on promising results from the CodeBreaK 100 trial, demonstrating meaningful response rates (~37%) in previously treated NSCLC patients with KRAS G12C mutations [2]. This positions LUMAKRAS as an essential component in the targeted therapy arsenal and signals strong initial demand.

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Market Dynamics Influencing LUMAKRAS Adoption

1. Competitive Landscape

LUMAKRAS’s principal competitors include Sotorasib’s closest rivals and emerging KRAS inhibitors. Notably, mirati’s adagrasib (MRTX849), which gained FDA approval shortly after LUMAKRAS, presents direct competition with comparable efficacy and safety profiles. The key differentiators include:

• Efficacy: Both drugs demonstrate similar Objective Response Rates (ORRs), but head-to-head clinical trials are pending.
• Dosing and Toxicity: LUMAKRAS’s once-daily dosing and manageable side effect profile favor its adoption.

Emerging therapies and ongoing clinical trials for combination regimens (e.g., KRAS inhibitors with immunotherapy) could further influence market share distribution.

2. Regulatory and Reimbursement Pathways

Regulatory approvals across key markets enable market penetration, while reimbursement decisions significantly impact access. The FDA’s priority review accelerated LUMAKRAS’s approval, and subsequent approvals in Europe and Japan expand its footprint. Payers’ positive reimbursement decisions hinge on demonstrated cost-effectiveness and real-world evidence, influencing sales trajectory.

3. Clinical Expansion and Labeling

Expanding indication labels beyond NSCLC to include other KRAS G12C-mutant tumors, such as colorectal and pancreatic cancers, is critical. Ongoing trials, including the CodeBreaK 200 and CodeBreaK 300, aim to establish efficacy in broader patient populations, which could materially increase market potential.

4. Market Penetration Factors and Adoption Barriers

• Physician Awareness: Early awareness and familiarity with KRAS testing influence prescribing patterns.
• Biomarker Testing Infrastructure: Widespread adoption of molecular diagnostics enables accurate patient selection, a prerequisite for optimized usage.
• Cost and Access Constraints: High drug cost and associated diagnostics may limit initial adoption, particularly in resource-constrained markets.

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Financial Trajectory and Revenue Forecasts

1. Initial Revenue Generation (2021–2023)

LUMAKRAS’s launch in 2021 generated approximately $87 million in global sales in 2022, surpassing analyst estimates due to rapid adoption in the U.S. and Europe. The demand primarily stems from heavily pre-treated NSCLC patients, with early-stage penetration advancing steadily.

2. Revenue Growth Drivers

• Market Expansion: Approval for additional indications can triple the target patient pool.
• Geographical Expansion: Entry into emerging markets and increased insurance coverage will bolster sales.
• Combination Therapies: Integration with immunotherapies in clinical development could unlock new revenue streams.

Analysts project that LUMAKRAS’s global sales could approach $1.2 billion by 2026, with a compound annual growth rate (CAGR) of roughly 40% from 2023 onward [3].

3. Risks and Revenue Dampeners

• Competitive Pressure: Adagrasib and novel KRAS inhibitors could restrict market share.
• Clinical and Regulatory Challenges: Delays in approval for expanded indications or unfavorable trial outcomes may impact revenue.
• Pricing and Reimbursement Dynamics: Increasing push for cost containment could lead to price negotiations and impact profitability.

4. Cost Analysis and Profitability

Amgen’s strategic investments in manufacturing, marketing, and molecular testing infrastructure are expected to weigh on near-term margins. However, high efficacy and market exclusivity confer significant pricing power, supporting margins in the mid to long term.

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Market Penetration and Future Outlook

The expanding scope of KRAS G12C mutations across various tumor types, coupled with ongoing clinical research, underpins a positive outlook for LUMAKRAS. The drug’s potential inclusion in combination therapies, such as with PD-1 inhibitors, offers avenues for significant growth, possibly doubling current sales figures within a decade.

Emerging trends like liquid biopsy diagnostics and companion testing are expected to enhance patient segmentation and facilitate timely treatment initiation, thereby accelerating market penetration. Moreover, strategic collaborations, licensing, and regional market entries are critical to achieving broad global footprint.

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Key Market Drivers

• Robust clinical efficacy in NSCLC
• Regulatory approvals in major markets
• Expansion into additional tumor types
• Strategic partnerships and combination trials
• Growing patient access through improved diagnostics

Market Challenges

• Intense competition from similar KRAS inhibitors
• High drug pricing pressures
• Diagnostic deployment complexities
• Navigating diverse regulatory landscapes
• Managing safety and resistance issues

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Conclusion

LUMAKRAS’s trajectory exemplifies the transformative potential of targeted therapies in oncology. Its market success depends on continued clinical validation, strategic expansion, and effective positioning against rivals. Given current trajectories, LUMAKRAS is positioned to become a multi-billion-dollar revenue driver for Amgen, influencing the valuation and competitive outlook in the KRAS-targeted cancer therapy domain.

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Key Takeaways

• LUMAKRAS is at the forefront of KRAS G12C mutation targeted therapies, with strong initial adoption and clinical validation.
• Competition from agents like adagrasib presents ongoing market challenges, but unique attributes and indication expansion provide growth opportunities.
• Regulatory approvals across major markets enable broad accessibility, while reimbursement dynamics remain pivotal.
• Expanding indications and combination therapies are expected to significantly enhance revenue streams.
• Strategic initiatives in diagnostics and global market penetration will be vital in maximizing financial and market potential.

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FAQs

1. What makes LUMAKRAS different from other anti-cancer treatments?
LUMAKRAS is the first FDA-approved targeted inhibitor specifically attacking KRAS G12C mutations, making it a cornerstone in precision medicine for certain lung cancers.

2. How quickly can LUMAKRAS achieve market penetration globally?
While initial uptake in the U.S. and Europe has been rapid, full global penetration depends on regulatory approvals, healthcare infrastructure, and payer acceptance, typically spanning 3–5 years for substantial market share.

3. What is the potential for LUMAKRAS in non-lung cancers?
Ongoing clinical trials aim to establish efficacy in colorectal and pancreatic cancers, where KRAS G12C mutations are present, potentially broadening its therapeutic and revenue scope.

4. How does LUMAKRAS’s pricing impact its market trajectory?
Premium pricing is justified by targeted efficacy and unmet need; however, reimbursement negotiations and healthcare cost pressures could influence net revenues.

5. What are the main risks that could hinder LUMAKRAS’s growth?
Competitive drugs, clinical development setbacks, regulatory delays, safety concerns, and cost/access barriers remain primary risks to sustained growth.

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Sources

[1] MarketsandMarkets. (2022). Oncology Drugs Market Analysis.
[2] Food and Drug Administration. (2021). FDA approves sotorasib for KRAS G12C-mutated NSCLC.
[3] EvaluatePharma. (2022). Oncology drug sales forecast and analysis.