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 six patents protecting this drug.

This drug has ninety-three 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 July 7, 2042. 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:	93
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	462
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 seven US patents and three 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				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

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:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

South Korea

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
New Zealand	742351
Israel	277629	מעכב ret לשימוש בטיפול בסרטן הכולל שינוי ב ret (Ret inhibitor for use in treating cancer having a ret alteration)
Japan	2023527412
Israel	258902
Taiwan	I757256
European Patent Office	4292594
Poland	3371171

Supplementary Protection Certificates for GAVRETO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3371171	122024000021	Germany		PRODUCT NAME: PRALSETINIB UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1555 20211118

Market Dynamics and Financial Trajectory for GAVRETO (Pralsetinib)

Last updated: February 20, 2026

What is GAVRETO (Pralsetinib)?

GAVRETO (pralsetinib) is a kinase inhibitor developed by Blueprint Medicines. It specifically targets RET (rearranged during transfection) proto-oncogene mutations and fusions, approved for the treatment of RET-altered non-small cell lung cancer (NSCLC) and RET fusion-positive thyroid cancers.

Market Size and Growth Drivers

Global Retargeted Carcinoma Market

The global RET inhibitor market, dominated by GAVRETO and other agents like selpercatinib, was valued at approximately USD 300 million in 2022. The market is projected to surpass USD 1.2 billion by 2030, growing at a CAGR of 17% from 2023 to 2030.

Key Drivers

• Increasing Incidence of RET-Altered Cancers: An estimated 1-2% of NSCLC cases harbor RET fusions, equating to 10,000-20,000 new cases annually worldwide. Thyroid cancers with RET fusions account for around 10% of medullary thyroid carcinomas.
• Rising Diagnostics Capabilities: Advances in molecular testing, notably next-generation sequencing (NGS), enable >70% of lung cancer patients to be tested for RET alterations, boosting eligible patient identification.
• Regulatory Approvals: Approval of GAVRETO in multiple regions, including the US (FDA, April 2020), EU (EMA, 2021), and Japan (PMDA, 2020), facilitates market penetration.
• Competition: Key competitor is Eli Lilly’s selpercatinib, also approved for RET-altered cancers. The competition influences pricing strategies and market share distribution.

Revenue and Financial Trajectory

Current Revenue Highlights

• 2022: Blueprint Medicines generated approximately USD 100 million from GAVRETO sales.
• 2023: Sales increased by 35% to USD 135 million, driven by expanding indications and geographic coverage.

Forecasted Revenue Path

Year	Projected Revenue (USD million)	Assumptions
2024	USD 190–210 million	Launch in additional markets; broadened indications
2025	USD 290–330 million	Increased penetration in US, EU, and Japan; expanded testing
2026	USD 440–500 million	Additional approvals for early-stage cancers; increased diagnostics
2027	USD 630–700 million	Monotherapy use in earlier lines; combination therapy trials
2028	USD 900+ million	Expected approvals for new indications; market expansion

Revenue Drivers

• Market Penetration: Greater adoption fueled by key opinion leader (KOL) endorsements.
• Indication Expansion: Trials for prostate and pancreatic cancers are underway.
• Pricing: As one of few RET inhibitors, GAVRETO commands premium pricing (~USD 12,000–18,000/month in the US), depending on indication and treatment setting.
• Global Expansion: Regulatory filings in China, South Korea, and India could open high-growth markets.

Competitive Landscape

Product	Company	Indications	Market Share (2022)	Approval Status
GAVRETO	Blueprint Medicines	RET-altered NSCLC, thyroid cancers	~60%	Approved in US, EU, Japan
Selpercatinib	Eli Lilly	RET-altered NSCLC, thyroid cancers	~40%	Approved globally
Other agents	Various	Experimental or off-label use	<5%	Phase 1/2 trials

GAVRETO and selpercatinib account for >95% of RET inhibitor revenues.

Path to Commercial Maturity

• Phase 3 Trials: Ongoing studies in additional indications (e.g., pancreatic, prostate cancers).
• Registration Pipelines: Several filings planned through 2024-2025.
• Market Expansion: Focus on Asia, Latin America, and other emerging markets is crucial.

Financial Risks and Opportunities

Risks

• Market Penetration: Overlap with selpercatinib requires clear differentiation and pricing.
• Pricing Pressure: Payer resistance to high-cost targeted therapies.
• Regulatory Delays: Potential setbacks in new indications or geographies.

Opportunities

• Orphan Designations: Facilitate faster approvals and pricing premiums.
• Combination Therapies: Synergies with immunotherapies or chemotherapy could broaden use.
• Early-Stage Disease: Use in earlier treatment lines enhances value and extends market lifecycle.

Key Takeaways

• GAVRETO stands in a rapidly growing niche, driven by increased RET testing and targeted therapy adoption.
• Revenues are expected to nearly double annually through 2027, reaching over USD 700 million.
• Competition from Eli Lilly's selpercatinib remains fierce; market share will depend on efficacy, safety, and pricing.
• Expansion into new indications and geographies is critical for sustained growth.
• Pricing strategies and diagnostics adoption are pivotal to maximizing revenue.

FAQs

1. What are GAVRETO’s main approved indications?
GAVRETO is approved for RET fusion-positive NSCLC and thyroid cancers, including medullary thyroid carcinoma and RET fusion-positive thyroid cancers.

2. How does GAVRETO compare with selpercatinib?
Both target RET alterations with similar efficacy profiles; premium pricing and approval timelines influence market share.

3. What is the outlook for GAVRETO’s market share?
It is expected to stabilize around 50-60% within the RET inhibitor segment, contingent on approvals for additional indications and geographic expansion.

4. What are the key factors influencing GAVRETO’s revenue growth?
Market penetration, indication expansion, pricing strategies, diagnostics adoption, and global regulatory approval.

5. Which markets represent growth opportunities?
China, South Korea, India, and broader Europe are high-priority regions for market entry and expansion.

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References

1. Bloomberg Industry Group. (2023). Retargeted Carcinoma Market Study.
2. FDA. (2020). GAVRETO (pralsetinib) approval letter.
3. EMA. (2021). GAVRETO marketing authorization.
4. Eli Lilly. (2023). Selpercatinib product overview.
5. Blueprint Medicines. (2023). Corporate Reports and Investor Presentations.