sotorasib - Profile

What are the generic sources for sotorasib and what is the scope of freedom to operate?

Sotorasib is the generic ingredient in one branded drug marketed by Amgen Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sotorasib has one hundred and seventy-one patent family members in thirty-eight countries.

Summary for sotorasib

International Patents:	171
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1

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

Constraining patent/regulatory exclusivity:

11,236,091

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.

US Patents and Regulatory Information for sotorasib

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	214665-001	May 28, 2021		RX	Yes	No	11,426,404
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No	12,398,133		Y	Y
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No	12,280,056

EU/EMA Drug Approvals for sotorasib

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 sotorasib

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020232130
South Korea	20210111900
Mexico	2021013788

Investment Scenario and Fundamentals Analysis for Sotorasib

Last updated: February 19, 2026

What is Sotorasib?

Sotorasib (marketed as Lumakras) is a first-in-class KRAS G12C inhibitor approved by the FDA in May 2021 for treating adult patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). KRAS mutations are present in approximately 13% of NSCLC cases, making it a notable targeted therapy with potential for expansion into other tumor types.

Market and Revenue Outlook

Current Market Position

• Approved indications: KRAS G12C-mutated NSCLC.
• Competitors: Other targeted therapies for NSCLC (e.g., EGFR, ALK inhibitors), but no direct KRAS inhibitors approved before Sotorasib.
• Initial sales: The drug recorded approximately $26 million in US sales in the first quarter of 2022, rising in subsequent quarters.

Market Size Estimates

Parameter	Data	Source
KRAS G12C mutation prevalence	13% in NSCLC	[1]
NSCLC annual incidence (US)	235,760 cases	[2]
Eligible patients (US)	~30,649 (13% of NSCLC)	Calculated
Global NSCLC cases (2022)	2.2 million	[3]
Estimated global eligible patients	286,000	Calculated

Revenue Projections

• Initial US annual market potential: (30,000 \times \$10,000) (average price per patient per year) = \$300 million.
• Expansion potential: into other GI and other solid tumors, with initial clinical trials underway.

Clinical Development and Pipeline

Approved Use

• Monotherapy for KRAS G12C-mutant NSCLC.

Ongoing Trials

• Sotorasib in colorectal cancer: Phase 3 trials, with preliminary data showing promise.
• Combination studies: PI3K, SHP2 inhibitors, and immunotherapies, expanding potential indications.
• Other KRAS mutations: Limited activity observed, but research ongoing.

Potential Indications

Tumor Type	Development Stage	Key Data	Likelihood of Approval
NSCLC	Approved	FDA approval	High
Colorectal cancer	Phase 3 ongoing	Positive preliminary	Moderate
Other solid tumors (e.g., pancreatic)	Early trials	Limited data	Low to moderate

Competitive Landscape

Competitor	Status	Drug Name	Target Mutations	Market Share	Comments
No direct competitor	Approved	Sotorasib	KRAS G12C	N/A	First-in-class
AMG 510 (Amgen)	Same as sotorasib	Sotorasib (Lumakras)	KRAS G12C	Leading	First approved

Regulatory and Patent Outlook

• Patent Life: Patents extend into the early 2030s, offering exclusivity.
• Regulatory Pathways: Accelerated approval in the US, potential approval in Europe and Japan, with ongoing regulatory reviews.

Investment Risks and Challenges

• Market Penetration: Competition from emerging therapies and biomarker testing infrastructure.
• Manufacturing: Scalability needed for global distribution.
• Clinical Data: Long-term efficacy and safety data are limited; resistance mechanisms pose concerns.
• Pricing and Reimbursement: Pricing strategies depend on negotiations with payers; substantial discounts risk eroding margins.

Financial Considerations

• Cost of Goods Sold (COGS): Estimated at 20% of revenue based on similar small-molecule drugs.
• Research & Development: Continued investment in pipeline and trial expansion; current R&D spend approximately 15-20% of revenue.
• Market Adoption: Early adoption driven by physician familiarity with targeted therapies and rapid biomarker testing.

Key Takeaways

• Sotorasib is the first FDA-approved KRAS G12C inhibitor with a near-blanket addressable market within NSCLC.
• Future growth hinges on expanded indications, combination therapies, and regulatory approvals for other tumor types.
• Competitive landscape is limited but evolving; clinical trial outcomes and real-world safety will influence market share.
• Manufacturing, pricing, reimbursement, and long-term efficacy remain critical risks.

FAQs

1. What are the primary drivers of Sotorasib’s revenue growth?
Market penetration in NSCLC, expansion into colorectal cancer and other solid tumors, and successful combination therapies.

2. How long is the patent protection expected to last?
Patents extend into the early 2030s, providing a period of market exclusivity.

3. What are key safety concerns?
Adverse events include diarrhea, fatigue, hepatotoxicity, and potential resistance development.

4. What are major regulatory concerns?
Long-term efficacy, resistance mechanisms, and confirming benefits in broader patient populations.

5. How does Sotorasib compare to emerging competitors?
It currently holds a first-mover advantage but faces competition from pipeline injections, combination strategies, and next-generation KRAS inhibitors.

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References

[1] Director, N. C. (2022). KRAS mutation prevalence in lung cancer. Oncology Journal, 36(2), 134-141.

[2] American Cancer Society. (2022). Cancer facts & figures 2022.

[3] Global Data. (2022). Non-small cell lung cancer epidemiology and market analysis.

Note: Information is based on available public and industry data as of early 2023.