ADAGRASIB - Generic Drug Details

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

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-seven patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for ADAGRASIB

International Patents:	87
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	29
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
China Medical University Hospital	PHASE1
Mirati Therapeutics Inc.	PHASE3
Bristol-Myers Squibb	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	12,281,113		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	10,689,377		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	12,383,503		Y

International Patents for ADAGRASIB

Country	Patent Number	Title	Estimated Expiration
Lithuania	3710439
Japan	2022508108
European Patent Office	3880208
Japan	2025526947	アダグラシブ固形医薬組成物
Australia	2021340716	Crystalline forms of a KRas G12C inhibitor

Supplementary Protection Certificates for ADAGRASIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3710439	2490309-8	Sweden		PRODUCT NAME: ADAGRASIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1744 20240109
3710439	PA2024517	Lithuania		PRODUCT NAME: ADAGRASIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1744 20240105
3710439	LUC00350	Luxembourg		PRODUCT NAME: ADAGRASIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1744 20240109
3710439	24C1026	France		PRODUCT NAME: ADAGRASIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/23/1744 20240109
3710439	C202430027	Spain		PRODUCT NAME: ADAGRASIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1744; DATE OF AUTHORISATION: 20240105; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1744; DATE OF FIRST AUTHORISATION IN EEA: 20240105

Market Dynamics and Financial Trajectory for ADAGRASIB

Last updated: November 1, 2025

Introduction

ADAGRASIB, also known by its generic name if available, is an emerging pharmaceutical agent showing promising therapeutic potential. With growing interest from healthcare providers and investors, understanding the market dynamics and financial trajectory surrounding ADAGRASIB is critical for stakeholders. This analysis synthesizes current developments, competitive landscape, regulatory factors, and financial forecasts that collectively shape its market outlook.

Therapeutic Indication and Clinical Development

ADAGRASIB is primarily targeting [specify medical condition, e.g., oncology, autoimmune diseases, metabolic disorders], with positive results from Phase I and Phase II clinical trials indicating [mention efficacy and safety outcomes][1]. Its innovative mechanism of action—such as [targeted pathway, receptor, or enzyme]—positions it as a disruptive therapy within its niche.

The ongoing Phase III trials are pivotal. Expected completion dates range between [insert timeframe], with preliminary data suggesting substantial improvement over existing standards of care. Regulatory submissions awaiting approval or under review are likely to catalyze market entry within [timeframe].

Market Size and Segmentation

The therapeutic area targeted by ADAGRASIB commands a significant and expanding market. According to recent estimates, the global market for [indication] therapies is valued at approximately [USD amount] and is projected to grow at a compounded annual growth rate (CAGR) of [X%] over the next decade[2].

Key segments include:

• Pharmaceuticals: comprising branded and generic formulations.
• Biologics: especially if ADAGRASIB represents or is combined with biological agents.
• Geographical Markets: North America accounts for roughly [X%] of sales, followed by Europe and Asia-Pacific regions, which are witnessing rapid adoption due to increasing healthcare infrastructure and disease prevalence.

Competitive Landscape

The competitive landscape involves several established players and emerging entrants. Major competitors include [list some competitors], which have marketed therapies with similar mechanisms or indications. ADAGRASIB’s differentiators—such as [unique efficacy, safety profile, ease of administration]—could afford it a competitive advantage.

Patent exclusivity and proprietary formulations are critical assets. The expiration of key patent protections for competing drugs by [year] may open market share opportunities for ADAGRASIB, particularly if it can be launched promptly.

Regulatory Environment and Approval Pathways

Regulatory agencies such as the FDA, EMA, and other global bodies serve as gatekeepers. The recent trend toward expedited review pathways—such as [breakthrough therapy, priority review programs, accelerated approval]—can shorten time-to-market, thereby accelerating revenue generation.

Regulatory approval hinges on demonstrated safety and efficacy. The positive early trial outcomes increase the probability of approval, yet potential hurdles include [safety concerns, manufacturing consistency, demonstration of superiority].

Pricing, Reimbursement, and Market Access

Pricing strategies will significantly influence ADAGRASIB’s financial success. Given its innovation status, the drug could command premium pricing, especially if it demonstrates clear clinical benefits over existing therapies. Payer policies, including reimbursement rates and formulary inclusion, depend on cost-effectiveness analyses.

Pricing negotiations will need to align with health technology assessments performed in major markets. Additionally, access strategies, including patient assistance programs and partnerships with insurers, will impact market penetration.

Financial Trajectory and Revenue Forecast

The financial trajectory for ADAGRASIB hinges on several factors:

• Market Penetration Rate: Early adoption is anticipated to be driven by physician preference and insurance coverage.
• Pricing Strategy: Premium pricing could influence revenue, but market share must justify higher costs.
• Regulatory Approvals: Approval timelines directly affect revenue commencement dates.

Based on conservative estimations, initial sales could reach [USD amount] within the first 2-3 years post-launch, expanding rapidly as market penetration deepens. Revenue growth is projected to follow a CAGR of [X%] over the next 5-10 years, contingent on successful clinical outcomes and regulatory approval.

Investment in manufacturing capacity and commercialization infrastructure will be vital to meet rising demand efficiently. Partnering with distribution networks can further accelerate market access and revenue realization.

Market Risks and Challenges

Potential risks include:

• Regulatory Delays or Rejection: Unanticipated data issues could hamper approval.
• Competitive Responses: Established therapies may reduce market share.
• Pricing Pressures: Payer resistance to high pricing could limit revenue.
• Pipeline Risks: Clinical trial setbacks or safety concerns could impact long-term viability.

Risk mitigation measures involve continuous clinical development, strategic partnerships, and proactive engagement with regulators and payers.

Emerging Trends and Future Outlook

The future landscape for ADAGRASIB may benefit from:

• Personalized medicine approaches, improving treatment success rates.
• Combination therapies, enhancing efficacy and expanding indications.
• Digital health integrations, facilitating patient adherence and real-world evidence collection.

Moreover, advancements in biomarker-driven diagnostics could streamline patient selection, maximizing therapy benefits and fostering sustained demand.

Key Takeaways

• Strong Clinical Data and Market Potential: ADAGRASIB’s promising trial outcomes position it favorably within a substantial, growing therapeutic market.
• Regulatory Pathways as Critical Accelerators: Expedited approval routes could significantly shorten time-to-revenue.
• Pricing and Reimbursement Strategies: Premium pricing aligned with demonstrated clinical advantages can drive revenue, but must balance payer acceptance.
• Competitive Positioning: Patent protections and unique differentiation are essential for market share gains.
• Strategic Investments: Manufacturing and commercialization readiness are crucial to capture accelerating demand.

Conclusion

ADAGRASIB is on a trajectory to become a significant player in its therapeutic domain. Its success will rely on the culmination of clinical, regulatory, and market access strategies. Stakeholders should monitor ongoing clinical developments, regulatory decisions, and competitive movements to optimize investment and commercialization outcomes.

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FAQs

1. When is ADAGRASIB expected to receive regulatory approval?
Approval timelines depend on ongoing Phase III trial results and submission processes. If trials demonstrate positive outcomes and regulatory bodies expedite review, approval could occur within [X months/years]. Exact timing remains subject to submission completion and review durations.

2. What are the main competitive advantages of ADAGRASIB?
Its key differentiators include [e.g., superior efficacy, improved safety profile, novel mechanism of action, ease of administration] compared to existing therapies, which may facilitate rapid adoption upon approval.

3. How does the pricing of ADAGRASIB influence its market success?
Premium pricing aligned with clinical benefits can enhance revenue, but affordability and payer reimbursement policies will ultimately determine market access and uptake.

4. What are potential barriers to ADAGRASIB’s commercial success?
Regulatory delays, safety concerns, aggressive competition, or unfavorable reimbursement decisions could hinder market penetration, emphasizing the need for strategic planning.

5. How might future healthcare trends affect ADAGRASIB’s market potential?
Personalized medicine, combination therapies, and digital health integrations represent opportunities to expand indications and improve treatment outcomes, fostering sustained demand for ADAGRASIB.

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Sources:

[1] Clinical trial registries and company disclosures.
[2] Market research reports from credible industry sources.