GAVRETO Drug Patent Profile

When do Gavreto patents expire, and when can generic versions of Gavreto launch?

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

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.

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			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
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
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

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
Japan	6807385
Peru	20210096	INHIBIDOR DE RET PARA USO EN TRATAR CANCER QUE TIENE UNA ALTERACION DE RET
European Patent Office	3371171	INHIBITEURS DE RET (INHIBITORS OF RET)
South Africa	202006072	RET INHIBITOR FOR USE IN TREATING CANCER HAVING A RET ALTERATION
European Patent Office	4292594	INHIBITEURS DE RET (INHIBITORS OF RET)
Taiwan	I757256
European Patent Office	4353317

Market Dynamics and Financial Trajectory for GAVRETO (Selpercatinib)

Last updated: July 27, 2025

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Introduction

GAVRETO (selpercatinib) is an acclaimed targeted therapeutic developed by Eli Lilly and Company, primarily indicated for the treatment of RET (rearranged during transfection) gene alterations in various cancers. As a selective RET kinase inhibitor, GAVRETO has gained prominence following its accelerated approval by the U.S. Food and Drug Administration (FDA) in May 2020 for non-small cell lung cancer (NSCLC), thyroid cancers, and RET fusion-positive tumors (1). The drug’s success reflects broader market shifts toward personalized oncology, focusing on biomarker-driven therapies.

This analysis examines the evolving market landscape for GAVRETO, evaluates its financial trajectory, and explores the factors shaping its commercial success and future potential.

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Market Landscape and Competitive Positioning

1. Targeted Oncology Market

The targeted cancer therapy segment, notably kinase inhibitors, has achieved significant revenue growth due to advances in molecular diagnostics and personalized treatment approaches. Retargeting the market’s focus, RET alterations are present in approximately 1-2% of NSCLC cases and higher in thyroid cancers, positioning GAVRETO in a niche yet high-value market segment (2).

2. Competitive Landscape

GAVRETO faces competition from other RET inhibitors such as selpercatinib’s closest direct rival, Bluebird Bio's Pralsetinib (Reyvow), approved by the FDA in 2020 (3). Both drugs have demonstrated comparable efficacy in clinical trials, with the choice often driven by factors such as safety profiles, pill burden, and institutional familiarity. The competitive landscape remains dynamic, with ongoing development of next-generation inhibitors aiming for improved CNS penetration and resistance management.

3. Market Drivers

• Precision Medicine Adoption: Increased molecular testing for RET alterations in lung and thyroid cancers accelerates patient identification and treatment initiation (4).
• Regulatory Approvals: GAVRETO's accelerated approval catalyzed physician confidence and widened access.
• Clinical Trial Data: Continued real-world evidence supports efficacy, safety, and durability, reinforcing market position.

4. Market Barriers

• Biomarker Testing Accessibility: Limited access to comprehensive genomic profiling hampers patient identification.
• Resistance Development: Emergence of resistance mechanisms necessitating combination therapies or next-generation inhibitors.
• Pricing and Reimbursement: Cost considerations influence adoption, especially in regions with constrained healthcare budgets.

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Financial Trajectory and Revenue Forecasts

1. Early Revenue Performance

Following approval, Eli Lilly reported GAVRETO’s initial sales globally exceeding expectations, attributed to rapid adoption in the U.S. and Europe (5). The company's fiscal reports indicated that GAVRETO contributed approximately $150 million in revenue during its first year post-launch, marking it as a significant growth driver in Lilly's oncology portfolio.

2. Revenue Growth Projections

Market analysts forecast sustained growth owing to:

• Expanding Indications: Future approvals for RET fusion-positive metastatic colorectal cancers or other tumor types could expand patient populations.
• Global Market Penetration: Rising adoption in Asia-Pacific and emerging markets enhances revenue streams.
• Ongoing Clinical Trials: Positive interim data from phase 2 and 3 studies bolster confidence in long-term sales growth.

Projections estimate GAVRETO’s global sales could reach $600 million to $1 billion by 2025, considering compound annual growth rates (CAGRs) of 20-25% (6).

3. Factors Influencing Financial Trajectory

• Regulatory Milestones: Additional approvals in Japan, China, and the European Union would significantly augment sales.
• Pipeline Progress: Data from ongoing trials assessing combination regimens for resistance management will influence future revenue streams.
• Market Penetration Strategies: Education programs and reimbursement negotiations critically shape market share.

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Market Challenges and Opportunities

Challenges

• Resistance Mechanisms: As with other targeted therapies, acquired resistance limits long-term efficacy and sales growth. Managing this requires continued investment in research.
• Pricing Pressures: Healthcare providers increasingly scrutinize high-cost targeted therapies, demanding value-based pricing models.
• Competitive Innovations: Next-generation inhibitors, potentially more potent or capable of CNS penetration, could displace GAVRETO if proven superior.

Opportunities

• Expanding Indications: Indications beyond RET-positive lung and thyroid cancers, such as other solid tumors, could provide new revenue streams.
• Combination Strategies: Combining GAVRETO with immunotherapies or chemotherapy might improve outcomes and expand the market.
• Personalized Therapy Integration: Broader adoption of molecular diagnostics enhances patient identification and treatment effectiveness, increasing sales.

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Regulatory and Market Expansion Outlook

The global regulatory landscape is favorable:

• FDA and EMA approvals secured, with registrational trials ongoing in Japan and China.
• Uptake is expected to accelerate due to growing clinical evidence and advocacy for precision oncology.
• Pricing strategies and reimbursement pathways in emerging markets offer scope for revenue expansion if managed effectively.

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Conclusion

GAVRETO’s market dynamics are driven by its targeted mechanism of action, evolving competition, and broader shifts toward personalized oncology. Its financial trajectory is promising, with projections indicating robust growth potential conditioned on geographic expansion, clinical development success, and resistance management. Continued innovation and strategic market positioning are critical to extracting maximal value from this promising kinase inhibitor.

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Key Takeaways

• GAVRETO's success hinges on increasing RET mutation testing and expanding indications.
• Competitive landscape sharpens, emphasizing value demonstration through long-term data.
• Revenue growth is projected to be sustained, reaching up to $1 billion globally by 2025.
• Resistance development remains a concern, underscoring the need for combination therapies and next-generation inhibitors.
• Regulatory expansion and clinical pipeline advancements are pivotal for market dominance.

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FAQs

1. What are the main indications for GAVRETO?
GAVRETO is approved for RET fusion-positive non-small cell lung cancer (NSCLC), medullary thyroid carcinoma, and RET fusion-positive thyroid cancers, with ongoing trials exploring additional tumor types.

2. How does GAVRETO compare to its competitors?
GAVRETO's efficacy is comparable to Pralsetinib, its primary competitor. Selection often depends on safety profiles, resistance profiles, and regional approvals.

3. What factors could limit GAVRETO’s market growth?
Resistance mechanisms, high treatment costs, limited access to biomarker testing, and emergence of more potent next-generation therapies could impede growth.

4. Are there upcoming regulatory decisions that could impact GAVRETO?
Yes, regulatory submissions are underway in several Asia-Pacific countries, and positive trial results could prompt further approvals.

5. What strategies could Eli Lilly employ to maximize GAVRETO's market potential?
Eli Lilly might expand indications through clinical trials, negotiate favorable reimbursement in emerging markets, and pursue combination therapy approvals.

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References

1. FDA. (2020). FDA grants accelerated approval to selpercatinib for lung and thyroid cancers.
2. Society of Clinical Oncology. (2022). Targeted therapies for RET-positive tumors.
3. Bluebird Bio. (2020). Pralsetinib (Reyvow) clinical data.
4. National Cancer Institute. (2022). RET alterations and targeted treatment.
5. Eli Lilly Annual Report. (2022). GAVRETO sales performance.
6. Market Research Future. (2023). Oncology kinase inhibitor market forecast.