KRAZATI Drug Patent Profile

Which patents cover Krazati, and what generic alternatives are available?

Krazati is a drug marketed by Bristol and is included in one NDA. There are four patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Krazati

Krazati will be eligible for patent challenges on December 12, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 21, 2043. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for KRAZATI

International Patents:	89
US Patents:	4
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for KRAZATI

KRAZATI is protected by five US patents and two 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
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
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			Y	Y

International Patents for KRAZATI

When does loss-of-exclusivity occur for KRAZATI?

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

Australia

Canada

Chile

China

Colombia

European Patent Office

Israel

Japan

Mexico

Peru

South Korea

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 KRAZATI around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2019340366	Combination therapies
China	120112284	阿达格拉西布固体药物组合物 (Solid pharmaceutical composition of adagraxib)
Lithuania	PA2024517
France	24C1026

Supplementary Protection Certificates for KRAZATI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3710439	C20240021	Finland
3710439	202440022	Slovenia		PRODUCT NAME: ADAGRASIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/23/1744; DATE OF NATIONAL AUTHORISATION: 20240105; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3710439	301279	Netherlands		PRODUCT NAME: ADAGRASIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/23/1744 20240109
3710439	2024C/525	Belgium		PRODUCT NAME: ADAGRASIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1744 20240109

Analysis of KRAZATI: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Summary

KRAZATI (generic name: adagrasib) is a targeted oncology drug developed for treating KRAS G12C-mutated non-small cell lung cancer (NSCLC) and other solid tumors. Since its initial approval by the FDA in 2022, KRAZATI has garnered significant interest from investors due to its potential within the expanding KRAS inhibitor market. This analysis details its current market position, growth drivers, competitive landscape, revenue projections, and investment considerations.

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What Is KRAZATI and How Does It Fit Into the Market?

Chemical and Mechanism of Action

Attribute	Details
Generic Name	Adagrasib
Manufacturer	Mirati Therapeutics Inc. (NASDAQ: MRTX)
Approval Date	April 2022
Indication	Treatment of KRAS G12C-mutated NSCLC
Mechanism	Selectively inhibits KRAS G12C mutations, a driver in 13% of NSCLC cases

Current Approved Uses

Key Indication	Market Segment	Status
KRAS G12C-mutated NSCLC	Oncology, targeted therapy	Approved (FDA, 2022)

Pharmacokinetics and Efficacy (Clinical Data)

Trial/Study	Results
KRYSTAL-1 (Phase 1/2)	ORR (Objective Response Rate): 42% in NSCLC, durable responses observed—median duration >10 months
Response Rate	Significant activity in heavily pre-treated populations
Safety Profile	Generally manageable; common adverse events include diarrhea, nausea, fatigue

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Market Dynamics

Global Oncology Market Context

Parameter	Data / Estimates
Global Oncology Drugs Market Size (2022)	~$167 billion
Expected CAGR (2022-2027)	7.2%
KRAS-targeted Therapies Market Size (2022)	~$2 billion
Projected Growth (2022-2027)	CAGR >20%

Key Drivers for KRAZATI Market Penetration

Driver	Impact
Unmet Need for KRAS G12C Mutations	Limited current therapies; high sensitivity to targeted inhibition
Oncologist Acceptance	Increasing familiarity with KRAS inhibitors due to efficacy data
Companion Diagnostics	Development of biomarker assays to identify eligible patients
Competitive Landscape	Other G12C inhibitors (e.g., sotorasib by Amgen) in the market, but differences in safety, efficacy, and patent status influence positioning

Competitive Landscape Overview

Competitor	Product Name	Approval Date	Differentiation
Amgen Inc.	sotorasib (Lumakras)	May 2021	First-in-class KRAS G12C inhibitor, approved for NSCLC
Mirati Therapeutics	adagrasib (KRAZATI)	April 2022	Potentially better safety profile, longer durability observed in trials
Others	Emerging molecules	-	Several entering clinical phase, but commercialization pending

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Financial Trajectory and Investment Potential

Revenue Projections (2023-2030)

Year	Estimated Revenue (USD Million)	Assumptions
2023	$150-200	Initial market penetration at key centers, early adoption, limited geographic reach
2024	$400-600	Expanded approval, broader clinical access, ongoing Phase 3 pivotal trials
2025	$900-1,200	Increased adoption after comparative efficacy data, label expansion, and potential new indications
2026	$2.0-3.0 billion	Market saturation expected with competitive positioning and physician adoption, possible approval for combination therapy
2027+	CAGR of 25-30% over initial years	Based on continued growth, new indications (e.g., other KRAS G12C mutant tumors), and potential geographic expansion

Cost & Pricing Strategy

Parameter	Details
Launch Price (US)	Estimated $12,000-$15,000/month (similar to sotorasib)
Pricing Factors	Efficacy, safety, patent protection, competition
Cost of Goods Sold (COGS)	Estimated 15-20% of revenue

Investment Highlights

• Market Potential: KRAS G12C mutations occur in approximately 13% of NSCLC cases (~60,000 new cases annually in the US alone), representing a significant opportunity.
• Growth Catalysts: Label expansion, combination trials, and global market entry.
• Risk Factors: Competitive pressures, clinical trial failures, regulatory changes, biosimilar emergence.

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Comparison of Key Market Players

Aspect	KRAZATI (Adagrasib)	Sotorasib (Lumakras)
Developer	Mirati Therapeutics	Amgen
Approval Date	April 2022	May 2021
Efficacy (ORR)	42% (KRYSTAL-1)	~37% (CodeBreaK 100)
Median Duration of Response	>10 months	~10 months
Safety Profile	Manageable, some diarrhea, fatigue	Similar adverse events
Market Penetration	Slightly behind due to earlier launch	First to market

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Regulatory and Policy Environment

Policy Area	Impact
FDA Fast Track, Breakthrough Designations	Accelerated review; facilitates rapid market access
Patent Protection	Firm until at least 2030; key for high-margin sales
Off-label Use Regulations	Increasing use in other KRAS-mutated tumors, contingent on clinical data

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Future Outlook and Strategic Considerations

Market Expansion Opportunities

Strategy	Details
Label Expansion	Including escalations into other solid tumors (colorectal, pancreatic)
Combination Therapy Development	Trials with immunotherapy, chemotherapy, and other targeted agents
Geographic Expansion	Asia, Europe, Latin America, where KRAS mutations are prevalent

Key Challenges and Risks

Risks	Mitigation Strategies
Competitive Launches	Strong clinical data, early market entry, strategic alliances
Regulatory Delays	Proactive engagement with regulators, robust clinical data
Resistance Development	Develop second-generation inhibitors or combination regimens

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Key Takeaways

• KRAZATI exemplifies the rise of targeted therapies for genetically defined cancers, with substantial market potential given the prevalence of KRAS G12C mutations.
• Early clinical data indicates robust efficacy and manageable safety, positioning KRAZATI as a competitive alternative to existing G12C inhibitors.
• Investment opportunities are driven by accelerated approvals, expanding indications, and potential global reach, but competitive dynamics and clinical risks remain.
• Revenue projections suggest a growth trajectory with a possible peak of over $3 billion annually by 2026, contingent on successful commercialization and adoption.
• Strategic expansion through combination therapies, label extensions, and geographic expansion are vital to maximizing long-term value.

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FAQs

1. What are the primary factors influencing KRAZATI's market success?
   Efficacy data, safety profile, regulatory approval scope, clinician adoption, and competitive dynamics primarily drive market success.

2. How does KRAZATI compare to sotorasib in clinical efficacy?
   Both drugs show comparable ORRs (~37-42%) and durable responses, with slight differences in safety profiles, positioning KRAZATI as a competitive alternative.

3. What are the main hurdles in expanding KRAZATI's indications?
   Demonstrating clinical efficacy in other tumor types and navigating regulatory approvals in those indications.

4. What is the strategic significance of combination therapy trials?
   They could enhance efficacy, overcome resistance, and expand patient population eligibility.

5. How does patent protection influence investment decisions?
   Patent life until approximately 2030 provides exclusivity, enabling premium pricing and market share, crucial for valuation and ROI.

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References

1. FDA Approval Announcement for KRAZATI
2. Mirati Therapeutics 2022 Annual Report
3. Market Research Future – KRAS Inhibitors Market Analysis
4. Clinical Trial Data – KRYSTAL-1 Study
5. Global Oncology Market Data 2022