SOTORASIB - Generic Drug Details

What are the generic drug 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.

One supplier is listed for this compound.

Summary for SOTORASIB

International Patents:	171
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	50
What excipients (inactive ingredients) are in SOTORASIB?	SOTORASIB excipients list
DailyMed Link:	SOTORASIB at DailyMed

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.

Recent Clinical Trials for SOTORASIB

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

Sponsor	Phase
M.D. Anderson Cancer Center	EARLY_PHASE1
Northwest Oncology Cooperative Group(GONO)	PHASE2
Arbeitsgemeinschaft fur Internistische Onkologie	PHASE2

See all SOTORASIB clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SOTORASIB

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	214665-003	Jun 26, 2024		RX	Yes	No	12,280,056
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	12,280,056
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes	11,827,635		Y	Y

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
Japan	2021020948
Taiwan	I824148
Saudi Arabia	521430905	أشكال الحالة الصلبة (SOLID STATE FORMS)
Chile	2019003394

SOTORASIB Market Analysis and Financial Projection

Last updated: February 15, 2026

What is the current market landscape for sotorasib?

Sotorasib (Libtayo revised, marketed as Lumakras in some markets), developed by Amgen, gained FDA approval in May 2021 for treating non-small cell lung cancer (NSCLC) with KRAS G12C mutation. Its initial approval was based on the CodeBreaK 100 trial, demonstrating an overall response rate of 37.1%, with a median duration of response of 10 months. The drug is prescribed as a targeted therapy primarily for advanced NSCLC with specific KRAS G12C mutations.

The global oncology drug market reached approximately $206 billion in 2022. Within this, targeted therapies accounted for 55%, reflecting a significant growth trend driven by precision medicine. Sotorasib is positioned as a first-in-class KRAS G12C inhibitor, with a potentially sizable market volume due to the prevalence of the mutation in NSCLC—estimated at roughly 13% of NSCLC cases, representing large patient pools in the U.S. and Europe.

How does sotorasib's market share compare to competitors?

Sotorasib faces competition primarily from adagrasib (MRTX849), developed by Mirati Therapeutics, which also targets KRAS G12C mutations. Approval for adagrasib was granted in December 2022 by the FDA for the same indication.

Drug	Approval Date	Market Position	Key Data	Ongoing Trials
Sotorasib	May 2021	First-mover in KRAS G12C	ORR: 37.1% in trial	CodeBreaK 200, 300
Adagrasib	Dec 2022	Competitor	ORR: 43% in ongoing trials	KRYSTAL-1 trial

Market penetration depends on factors including drug efficacy, safety profiles, approval speed, and pricing strategies.

What is sotorasib's expected financial trajectory?

Amgen reported initial revenues of approximately $206 million during the first year post-launch, with a rapid increase to $400 million in 2022. The drug’s pricing in the U.S. is approximately $12,500 per month. The company projects sotorasib’s sales to reach between $2 billion to $3 billion globally by 2026, assuming steady market adoption and expanding indications.

The financial outlook assumes:

• Continued approval for additional indications, such as colorectal cancer, where KRAS G12C mutations are present.
• Expansion into first-line treatment options, which could double or triple the market size.
• Improved combination therapies with immunotherapies, increasing treatment efficacy and patient population.

Amgen maintains a cost-effective manufacturing process, with gross margins exceeding 80%. R&D investments are ongoing, with approximately $4.7 billion allocated to oncology R&D in 2022, of which sotorasib benefits from pipeline expansion investments.

What regulatory and pipeline developments influence sotorasib’s sales?

Regulatory review for expanding sotorasib's indications is underway in multiple jurisdictions. The FDA is evaluating sotorasib’s use in first-line NSCLC, with decision expected by the end of 2023, guided by the KRYSTAL-12 trial data. Approval for expanded indications in colorectal and other solid tumors could substantially increase sales.

Combination therapy trials are in progress, pairing sotorasib with PD-1 inhibitors, aiming to tackle resistance mechanisms and enhance response rates. Positive trial outcomes could secure approvals in earlier treatment settings, broadening the drug’s clinical utility.

What are the risks affecting the financial trajectory?

Key risk factors include:

• Market entry of generics post-exclusivity, expected around 2031.
• Emergence of resistance mutations reducing efficacy over time.
• Competitive dynamics from adagrasib or future KRAS inhibitors.
• Regulatory setbacks in expanding indications or unexpected safety concerns.
• Pricing pressures from payers limiting reimbursement levels.

Key Takeaways

Sotorasib represents a first-generation KRAS G12C targeted therapy with strong early sales and potential for expansion. Its market growth hinges on approval timelines, combination treatment success, and competition. Revenue projections suggest a multiple-billion-dollar opportunity, tempered by patent expiration risks and evolving competitive landscape.

FAQs

1. What is the primary indication for sotorasib?
   Advanced NSCLC with KRAS G12C mutation.

2. When will sotorasib face generic competition?
   Patent expiration in the U.S. is projected around 2031.

3. Are other cancers targeted by sotorasib?
   Trials explore colorectal and other solid tumors with KRAS G12C mutation.

4. How does sotorasib compare to adagrasib?
   Adagrasib exhibits higher response rates in trials but is not yet widely marketed.

5. What is the potential market size for sotorasib?
   Estimated to reach $2-3 billion globally by 2026, contingent on approval and adoption.

References

1. Amgen Financial Reports 2022
2. FDA approval documentation
3. CodeBreaK 100 Trial Results
4. Mirati Therapeutics KRYSTAL-1 Trial
5. Global Oncology Market Data