Adagrasib - Generic Drug Details

What are the generic drug sources for adagrasib and what is the scope of patent protection?

Adagrasib is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Adagrasib has eighty-nine patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for adagrasib

International Patents:	89
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	31
What excipients (inactive ingredients) are in adagrasib?	adagrasib excipients list
DailyMed Link:	adagrasib at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY

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 adagrasib

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

Sponsor	Phase
City of Hope Medical Center	PHASE2
National Cancer Institute (NCI)	PHASE2
M.D. Anderson Cancer Center	EARLY_PHASE1

See all adagrasib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for adagrasib

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

US Patents and Regulatory Information for adagrasib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes			Y	Y
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes			Y
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes			Y	Y
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes

International Patents for adagrasib

Country	Patent Number	Title	Estimated Expiration
Malaysia	200356
European Patent Office	4501932
Israel	318882	תכשירים פרמצבטיים מוצקים של אדאגראסיב (Adagrasib solid pharmaceutical compositions)
World Intellectual Property Organization (WIPO)	2020101736
Chile	2025000438	Composiciones farmacéuticas sólidas de adagrasib
Mexico	2025001991	COMPOSICIONES FARMACEUTICAS SOLIDAS DE ADAGRASIB (ADAGRASIB SOLID PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for adagrasib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3710439	20/2024	Austria		PRODUCT NAME: ADAGRASIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1744 (MITTEILUNG) 20240109
3710439	301279	Netherlands		PRODUCT NAME: ADAGRASIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/23/1744 20240109
3710439	PA2024517,C3710439	Lithuania		PRODUCT NAME: ADAGRASIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1744 20240105
3710439	C20240021	Finland
3710439	2490309-8	Sweden		PRODUCT NAME: ADAGRASIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1744 20240109
3710439	LUC00350	Luxembourg		PRODUCT NAME: ADAGRASIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1744 20240109

Market Dynamics and Financial Trajectory for Adagrasib

Last updated: February 20, 2026

What is Adagrasib, and how does it fit into the oncology market?

Adagrasib (MRTX849) is a selective KRAS G12C inhibitor developed by Mirati Therapeutics. It targets a mutation prevalent in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Approved under Accelerated Approval by the FDA in December 2022 for KRAS G12C-mutated NSCLC after prior therapies, it is positioned as a targeted therapy for a specific genetic subset.

The global oncology market exceeds $200 billion in annual revenue. KRAS mutations occur in approximately 13% of NSCLC cases and 3–4% of CRC cases. The drug’s primary competitors include Amgen’s Lumakras (sotorasib), approved in 2021, which shares indication and challenges with adagrasib.

What are the current sales and revenue figures?

As of Q2 2023, Mirati Therapeutics reported that adagrasib generated approximately $9 million in revenue. The drug remains in early commercialization stages with limited sales volume. Analysts project that annual sales could reach $150–$300 million within five years, contingent on regulatory approvals for additional indications, such as colorectal cancer, and expanding line-of-therapy options.

How do regulatory statuses impact the market present and future?

• FDA Approval: Approved for KRAS G12C-mutated NSCLC post-chemotherapy or immunotherapy. An accelerated pathway limits initial market size but provides expedited access.

• EMA and Other Markets: Regulatory submissions are ongoing, with approvals expected in European and Asian markets over the next 12–24 months.

• Additional Indications: Mirati is conducting trials for adagrasib in CRC and as a first-line therapy in NSCLC. Positive results could significantly expand market opportunity.

What factors influence the competitive landscape?

• Direct Competition: Sotorasib is the leading KRAS G12C inhibitor; launched in 2021, with sales surpassing $300 million in 2022. Both drugs have similar mechanisms and indications but differ in dosing and side effect profiles.

• Pipeline and Pipeline Competition: Multiple pharmaceutical companies develop KRAS inhibitors, including Moderna and Revolution Medicines, aiming to introduce next-generation agents with improved efficacy or safety profiles.

• Pricing and Reimbursement: Pricing strategies for adagrasib are likely to mimic sotorasib’s, set at approximately $17,000–$19,000 per month in the U.S., with payers negotiating discounts.

• Market Access and Adoption: Adoption depends on real-world efficacy, safety data, and clinician familiarity.

What are the key financial risks and opportunities?

• Risks:

  • Limited initial indications restrict initial revenue.
  • Emergence of competitors may reduce market share.
  • The accelerated approval pathway creates uncertainty on long-term reimbursement and label expansion.

• Opportunities:

  • Success in ongoing trials for CRC and combination regimens could expand the addressable market.
  • Potentially securing first-line approval could lift annual revenue into hundreds of millions.
  • Strategic collaborations or licensing agreements may accelerate commercialization and market penetration.

How do manufacturing, supply chain, and pricing strategies influence market potential?

• Manufacturing: Mirati has scaled production for clinical and initial commercial supply. Expansion capacity will be essential if indications expand or market share increases.

• Supply Chain: Ensuring consistent drug supply, especially in international markets, influences availability and patient access.

• Pricing: Maintaining competitive pricing relative to sotorasib, while balancing reimbursement negotiations, impacts revenue potential.

What is the outlook for its financial trajectory?

Mirati expects adagrasib’s revenue to grow modestly in the short term, constrained by initial indication limitations. Long-term growth hinges on successful trial outcomes, regulatory approvals, and market adoption. Industry analysts project a peak sales potential between $150 million and $300 million annually over the next five years, excluding potential indications outside NSCLC.

Key Takeaways

• Adagrasib faces early-stage commercial challenges but benefits from targeted therapy demand.
• Competition from sotorasib is intense, affecting market share.
• Expansion into colorectal and first-line NSCLC therapy presents significant growth opportunities.
• Revenue projections depend on regulatory success, clinical trial outcomes, and payer reimbursement strategies.
• Pricing strategies will influence market accessibility and profit margins.

FAQs

1. What are the main advantages of adagrasib over competitors?
It exhibits a longer half-life, tolerability profile, and potential efficacy in certain patient populations, but head-to-head trials are pending.

2. When will adagrasib likely gain approval for additional indications?
Results from ongoing trials in CRC are expected in 2024–2025, with potential regulatory submissions shortly thereafter.

3. How susceptible is adagrasib to biosimilar competition?
As a small-molecule targeted therapy, it is less vulnerable to biosimilars. Generic KRAS inhibitors are unlikely in the near term.

4. What is the potential impact of combination therapies involving adagrasib?
Combining with chemotherapy, immunotherapy, or other targeted agents could expand indications and improve outcomes, boosting revenue.

5. What are the critical market risks for Mirati’s commercial strategy?
Limited initial indications, competitive landscape, pricing negotiations, and regulatory hurdles in foreign markets.

References

[1] Mirati Therapeutics. (2023). Q2 2023 Financial Results.
[2] FDA. (2022). Approval letter for adagrasib.
[3] Ton, L. (2022). KRAS inhibitors: Market analysis. Oncology Today, 35(4), 12–15.
[4] GlobalData. (2023). Oncology drug market forecast.
[5] EvaluatePharma. (2023). Oncology market analytics.