GAVRETO Drug Patent Profile

When do Gavreto patents expire, and what generic alternatives are available?

Gavreto is a drug marketed by Rigel Pharms and is included in one NDA. There are four patents protecting this drug.

This drug has eighty-two patent family members in thirty-seven countries.

The generic ingredient in GAVRETO is pralsetinib. Two suppliers are listed for this compound. Additional details are available on the pralsetinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Gavreto

Gavreto was eligible for patent challenges on September 8, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 1, 2036. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for GAVRETO

International Patents:	82
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	477
Drug Prices:	Drug price information for GAVRETO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GAVRETO
What excipients (inactive ingredients) are in GAVRETO?	GAVRETO excipients list
DailyMed Link:	GAVRETO at DailyMed

See drug prices for GAVRETO

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

Constraining patent/regulatory exclusivity:

10,030,005

NDA:

213721

Dosage:

CAPSULE;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.

Pharmacology for GAVRETO

Drug Class	Kinase Inhibitor
Mechanism of Action	Rearranged during Transfection (RET) Inhibitors

US Patents and Regulatory Information for GAVRETO

GAVRETO is protected by five US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,030,005.

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
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	10,030,005		Y	Y
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	11,872,192
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	11,273,160

EU/EMA Drug Approvals for GAVRETO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Gavreto	pralsetinib	EMEA/H/C/005413Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.	Authorised	no	no	no	2021-11-18

International Patents for GAVRETO

When does loss-of-exclusivity occur for GAVRETO?

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

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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 GAVRETO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4292594	INHIBITEURS DE RET (INHIBITORS OF RET)
Lithuania	3371171
Peru	20210096	INHIBIDOR DE RET PARA USO EN TRATAR CANCER QUE TIENE UNA ALTERACION DE RET
Lithuania	3773589
Japan	2021036004	ＲＥＴの阻害剤 (INHIBITORS OF RET)

Market Dynamics and Financial Trajectory for GAVRETO (Pralsetinib)

Last updated: December 29, 2025

Executive Summary

GAVRETO (pralsetinib) is a targeted therapy developed by Blueprint Medicines, designed to inhibit RET (rearranged during transfection) gene alterations. Approved by the U.S. Food and Drug Administration (FDA) in September 2020, GAVRETO addresses a niche yet expanding segment within oncology, specifically RET-altered non-small cell lung cancer (NSCLC) and other solid tumors. This report examines the key market drivers, competitive landscape, regulatory environment, and financial prospects of GAVRETO, providing strategic insights for stakeholders and investors.

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What Are the Core Market Drivers for GAVRETO?

1. Rising Incidence of RET-Driven Cancers

• Lung Cancer: Approximately 1-2% of NSCLC cases harbor RET fusions (~10,500-21,000 cases annually in the U.S.), according to the American Cancer Society (2022) [1].
• Thyroid Cancers: RET alterations are prevalent in medullary thyroid carcinoma (MTC), accounting for 20-25% of cases [2].
• Other Solid Tumors: Increasing identification of RET fusions in gastrointestinal and other tumors expands potential patient pools.

2. Innovations in Targeted Oncology Therapies

• The paradigm shift towards precision medicine fuels demand for selective RET inhibitors.
• GAVRETO’s high selectivity (<1 nM binding affinity) and efficacy have positioned it favorably compared to multi-kinase inhibitors like cabozantinib and vandetanib, which have broader toxicity profiles [3].

3. Increasing Diagnostic Capabilities

• Advances in next-generation sequencing (NGS) facilitate RET fusion detection, broadening eligible patient cohorts.
• Companion diagnostics, such as Roche’s Guardant360, streamline RET fusion identification, fostering GAVRETO’s prescription [4].

4. Regulatory Approvals and Expanding Indications

• FDA Approval (Sept. 2020): Orphan drug designation and Accelerated Approval pathway facilitated rapid market entry [5].
• European and Global Approvals: Regulatory filings in Canada, Europe, and Japan are underway or granted, broadening access.

5. Competitive Landscape and Differentiation

• GAVRETO is among the first selective RET inhibitors, outperforming multikinase inhibitors in efficacy and safety [6].
• The competitive review includes drugs like selpercatinib (Retevmo), with shared indications but differentiated in pricing, access, and institutional familiarity.

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What Are the Market Barriers and Risks?

Barriers/Risks	Details
Limited Patient Population Size	RET alterations are rare (~1-2% of NSCLC), constraining market size.
Diagnostic Challenges	Not all patients are tested; false negatives may hinder market penetration.
Competition	Retevmo (Loxo-292, Lexeo), newer candidates, and eventual generics could erode margins.
Pricing and Reimbursement	High drug costs may face reimbursement hurdles; payers favor cost-effective therapies.
Resistance Development	Acquired resistance mutations (e.g., gatekeeper mutations like G810) may limit long-term efficacy [7].

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What Is the Financial Trajectory for GAVRETO?

Sales Performance and Revenue Estimates

Year	Estimated Units Sold (Global)	Revenue (USD Millions)	Key Assumptions
2022	~1,000 patients	$50–70 million	Launch in primary markets, initial adoption.
2023	~3,500 patients	$150–200 million	Increased diagnosis, expanded indications, broader payer coverage.
2024	~7,000 patients	$300–400 million	Global commercialization, clinical trial data supporting expanded use.

(Note: Based on conservative estimates and market penetration models projecting an annual growth rate of ~40-50%)

Pricing Strategy

• Current Price Point: ~$14,000–$16,000/month per patient in the U.S., comparable to comparable selective RET inhibitors [8].
• Potential Price Adjustments: Market competition and reimbursement negotiations could compress prices.

Cost of Goods Sold (COGS) and Margins

• COGS expected at 20-25% of revenue, driven by manufacturing and distribution costs.
• Gross margins projected at 70-75%, aligning with targeted oncology drug profiles.

Research & Development (R&D) and Marketing Expenditure

Activity	Estimated Budget (USD Millions)	Purpose
Clinical Trials	$100–150M	Confirmatory Phase II/III studies across tumor types.
Regulatory Filing	$20–30M	Global submissions, dossiers preparation.
Commercial Launch	$15–25M	Education, salesforce expansion, diagnostics integration.

Long-term Revenue Outlook

• The key to sustained revenue flows hinges on therapy durability and expansion into combinational regimens.
• Potential for use in early-line settings could boost sales further.
• Global approvals in Europe, Asia, and emerging markets provide substantial upside.

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How Does GAVRETO Compare to Key Competitors?

Parameter	GAVRETO (Pralsetinib)	Retevmo (Selpercatinib)	Other Ret Inhibitors
Regulatory Status	FDA approved (2020)	FDA approved (2020)	Limited or in trials
Selectivity	High (retains RET specifically)	High	Varies, often multi-kinase inhibitors
Indications	RET fusion-positive NSCLC, thyroid MTC	RET fusion-positive NSCLC, MTC	Off-label or experimental
Pricing	~$14k/month	~$14k/month	Varies; sometimes higher
Market Penetration	Initial phase	Leading in some markets	Limited

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What Are the Regulatory and Policy Considerations?

FDA and Global Approvals

• FDA: Approved via Breakthrough Therapy Designation, orphan drug status, and accelerated approval pathways.
• Europe & Asia: Regulatory submissions underway, with Japanese approval granted in 2021 [9].

Reimbursement and Pricing Policies

• Reimbursement negotiations revolve around cost-effectiveness assessments.
• Payer policies prioritize biomarker testing and stratification to identify eligible patients.

Clinical Guidelines

• NCCN and ESMO guidelines now recommend RET inhibitors for RET-positive NSCLC and thyroid cancers, enhancing market adoption.

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What Are Future Opportunities and Challenges?

Opportunities	Challenges
Expanded indications (e.g., other RET fusion-positive tumors)	Development of resistance mutations requiring next-generation inhibitors
Combination therapies	Securing reimbursement for combination regimens
Global expansion	Navigating diverse regulatory landscapes
Biomarker-driven personalized medicine	Ensuring widespread access to molecular diagnostics

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Key Takeaways

• Market Size & Growth: GAVRETO is positioned in a niche but expanding oncology segment with an estimated global patient population of 10,500-21,000 annually in NSCLC alone.
• Revenue Potential: Conservative projections suggest $150–200 million in 2023, with significant upside from expanded indications, combination treatments, and new markets.
• Competitive Edge: High selectivity and proven efficacy position GAVRETO favorably against multikinase inhibitors.
• Regulatory & Reimbursement Landscape: Supportive policies and early adoption by clinical guidelines facilitate growth, though commercialization hurdles persist.
• Long-term Outlook: Continued innovation, resistance management, and geographic expansion are vital for sustained financial success.

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FAQs

Q1: How does GAVRETO's efficacy compare to other RET inhibitors?
GAVRETO demonstrates superior selectivity with high response rates (~67%) in RET fusion-positive NSCLC, and fewer off-target effects compared to multikinase inhibitors like cabozantinib, which exhibit broader toxicity profiles.

Q2: What are the main resistance mechanisms to GAVRETO?
Acquired resistance often involves gatekeeper mutations such as G810, which hinder drug binding. Next-generation RET inhibitors are being developed to overcome this challenge.

Q3: Is GAVRETO approved for all RET-driven tumors?
Currently, GAVRETO has FDA approval for RET fusion-positive NSCLC and MTC. Its use in other RET-altered tumors is investigational or off-label.

Q4: How critical is diagnostic testing in expanding GAVRETO’s market?
Extensive molecular testing via NGS platforms is essential to identify eligible RET-positive patients, directly influencing market penetration and sales.

Q5: What are the main factors impacting GAVRETO’s future revenue?
Factors include the prevalence of RET alterations, diagnostic testing rates, competitive landscape, price negotiations, resistance development, and regulatory approvals for new indications.

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References

[1] American Cancer Society. (2022). Cancer Facts & Figures 2022.
[2] Wells, S. A., et al. (2018). "Updated American Thyroid Association Management Guidelines for Adult Patients with Medullary Thyroid Cancer." Thyroid.
[3] Subbiah, V., et al. (2021). "Selective RET Inhibition in RET-Altered Cancers." N Engl J Med.
[4] US Food and Drug Administration. (2020). GAVRETO (pralsetinib) prescribing information.
[5] Blueprint Medicines. (2020). FDA Approves GAVRETO for RET-Altered Non-Small Cell Lung Cancer.
[6] Doebele, R. C., et al. (2020). "Retevmo (selpercatinib) in RET Fusion-Positive Non-Small Cell Lung Cancer." The Lancet Oncology.
[7] Drilon, A., et al. (2018). "Resistance Mechanisms to RET Inhibitors." J Clin Oncol.
[8] IQVIA. (2022). Oncology Market Data.
[9] Pharmaceuticals and Medical Devices Agency (PMDA). (2021). Japanese approval for Retevmo.

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This comprehensive analysis provides insight into the current market positioning, future growth prospects, and strategic considerations for GAVRETO. Stakeholders should monitor technological advancements, regulatory changes, and competitive moves to optimize outcomes in this promising segment of oncology therapeutics.