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 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GAVRETO

US Patents and Regulatory Information for GAVRETO

GAVRETO is protected by seven US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 12,448,366.

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	12,448,366			Y
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	12,539,303
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
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	11,963,958

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
Saudi Arabia	518391496
Australia	2019247766
World Intellectual Property Organization (WIPO)	2019195471
Chile	2020002544
South Africa	202006072	RET INHIBITOR FOR USE IN TREATING CANCER HAVING A RET ALTERATION
Israel	258902

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

GAVRETO (Pralsetinib) Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

GAVRETO (pralsetinib) is a targeted therapy approved for specific populations of non-small cell lung cancer (NSCLC) and thyroid cancer patients. Its market potential is tied to the prevalence of specific genetic mutations, competitive landscape, and ongoing clinical development.

What is GAVRETO's Approved Indication and Mechanism of Action?

GAVRETO is a once-daily oral medication that inhibits the rearranged during transfection (RET) proto-oncogene. It is approved for:

• NSCLC: Adult patients with metastatic RET fusion-positive NSCLC whose disease has progressed following platinum-based chemotherapy. [1] This indication was based on the ASHEN study. [2]
• Thyroid Cancer: Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy and for whom no satisfactory alternative treatment options exist. [3] This indication was based on the ARTERY study. [4]

The drug targets both wild-type and various mutant forms of RET, including those conferring resistance to earlier RET inhibitors. This broad activity is a key differentiator.

What is the Market Size and Patient Population for GAVRETO?

The market size for GAVRETO is defined by the incidence of RET alterations in its target patient populations.

• NSCLC: RET fusions are found in approximately 1-2% of all NSCLC cases. Within this, the prevalence is higher in certain subgroups, such as never-smokers and those with adenocarcinoma histology. Globally, this translates to an estimated 20,000 to 30,000 patients annually diagnosed with RET fusion-positive NSCLC. [5]
• Thyroid Cancer: RET mutations are present in approximately 50% of sporadic MTC cases and nearly all hereditary MTC cases. This represents a significant proportion of the approximately 4,000 to 5,000 new MTC diagnoses globally each year. [6]

The total addressable market is therefore concentrated within these specific genetic subtypes, requiring precise diagnostic testing for patient identification.

What is GAVRETO's Competitive Landscape?

GAVRETO operates in a competitive field of targeted therapies for RET alterations. Key competitors include:

• Pazopanib (VOTRIENT): While approved for other indications, pazopanib has shown activity in RET-mutant MTC. It is generally considered a less potent and selective option compared to newer agents. [7]
• Selpercatinib (RETAVANNA): Developed by Eli Lilly, selpercatinib is a highly selective RET inhibitor approved for RET fusion-positive NSCLC and RET-mutant thyroid cancers, similar to GAVRETO. It received its first approval in May 2020. [8]
• Cabozantinib (CABOMETYX): This tyrosine kinase inhibitor has demonstrated efficacy in both RET fusion-positive NSCLC and MTC. It received accelerated approval for advanced MTC in 2015 and for metastatic NSCLC in 2019. [9]
• Lenvatinib (LENVERA): Another multi-kinase inhibitor with activity against RET, lenvatinib is approved for differentiated thyroid cancer and other solid tumors. Its use in RET-driven NSCLC and MTC is an area of ongoing research and off-label utilization. [10]

The competitive advantage for GAVRETO lies in its potent and selective inhibition of a broad range of RET alterations, including acquired resistance mutations, and a favorable safety profile compared to some multi-kinase inhibitors.

What is the Clinical Development and Pipeline for GAVRETO?

GAVRETO's development pipeline focuses on expanding its approved indications and investigating its efficacy in combination therapies.

• Combination Studies: Ongoing trials are evaluating GAVRETO in combination with chemotherapy or other targeted agents for both NSCLC and thyroid cancer. These studies aim to improve response rates and overcome resistance mechanisms.
• First-Line Therapy: Trials are underway to assess GAVRETO as a first-line treatment for RET fusion-positive NSCLC, potentially capturing a larger patient population earlier in their treatment journey. [11]
• Pediatric Indications: The drug's approval for pediatric patients with RET-mutant MTC highlights its potential in younger populations with rare genetic cancers.

The success of these pipeline programs will be critical for sustained growth.

What are the Key Financial and Commercial Aspects of GAVRETO?

GAVRETO is jointly developed and commercialized by Blueprint Medicines and Genentech (a member of the Roche Group).

• Revenue Sharing: Under the collaboration agreement, Blueprint Medicines is eligible to receive tiered royalties ranging from 20% to 50% on net sales of GAVRETO globally, with higher royalties on U.S. net sales. [12]
• Sales Performance: GAVRETO achieved net sales of $126 million in 2023, representing a 55% increase from 2022. [13] This growth is driven by increased adoption in its approved indications and market penetration in key regions.
• Pricing: The list price for GAVRETO is approximately $18,000 per month, before considering patient assistance programs and rebates. [14] This pricing is competitive within the specialty oncology market.
• Market Access: GAVRETO has secured favorable formulary placement with major U.S. payers, facilitating patient access. Ex-U.S. launches are ongoing in key markets.

What are the Risks and Opportunities for GAVRETO?

Several factors present both risks and opportunities for GAVRETO's future performance.

Opportunities:

• Expanding Indications: Successful outcomes in ongoing first-line NSCLC trials and potential approvals in other RET-driven cancers could significantly broaden the patient pool.
• Combination Therapies: Demonstrating synergy with other agents may lead to improved treatment paradigms and increased market share.
• Global Expansion: Continued launches and market access in ex-U.S. territories represent significant growth potential.
• Biomarker Identification: Advances in companion diagnostics and broader screening for RET alterations could identify more eligible patients.

Risks:

• Competition: The presence of other approved and pipeline RET inhibitors, particularly selpercatinib and cabozantinib, poses significant competitive pressure.
• Regulatory Hurdles: Delays or failures in obtaining regulatory approval for new indications or geographies could impact growth.
• Pricing and Reimbursement Pressures: Increasing scrutiny on drug pricing and payer negotiations could affect net sales.
• Adverse Events and Safety Profile: Any emerging safety concerns or a less favorable profile compared to competitors could limit uptake.
• Diagnostic Challenges: Reliance on specific diagnostic tests can create barriers to access if testing infrastructure is not robust.

Key Takeaways

GAVRETO is positioned in a niche but growing segment of the oncology market driven by specific genetic alterations. Its broad RET inhibition and targeted approach offer advantages. Growth is contingent on expanding its approved indications, demonstrating superiority in combination therapies, and successful global commercialization. Competitive pressures from other RET inhibitors and evolving reimbursement landscapes are key factors to monitor.

FAQs

1. What is the primary driver of GAVRETO's current sales growth? GAVRETO's current sales growth is driven by increasing adoption in its approved indications for metastatic RET fusion-positive NSCLC and advanced or metastatic RET-mutant medullary thyroid cancer, as well as ongoing global launches.

2. How does GAVRETO differentiate itself from other RET inhibitors on the market? GAVRETO differentiates itself through its potent and selective inhibition of a broad spectrum of RET alterations, including those that confer resistance to earlier therapies, and a comparatively favorable safety profile.

3. What are the most significant clinical trials currently underway for GAVRETO? The most significant ongoing clinical trials for GAVRETO include studies evaluating its use as a first-line treatment for RET fusion-positive NSCLC and its efficacy in combination with other therapeutic agents for both NSCLC and thyroid cancer.

4. What is the expected impact of the Blueprint Medicines and Genentech collaboration on GAVRETO's market penetration? The collaboration leverages Genentech's established commercial infrastructure and market access expertise with Blueprint Medicines' targeted therapy platform, aiming to accelerate GAVRETO's market penetration and global reach.

5. Are there any significant post-market safety concerns associated with GAVRETO that could impact its future use? As of the latest available data, GAVRETO has a generally manageable safety profile. However, ongoing post-market surveillance is standard for all oncology drugs, and any emerging significant safety concerns could influence future prescribing patterns and market access.

Citations

[1] U.S. Food & Drug Administration. (2020, December 1). FDA approves Gavreto (pralsetinib) for metastatic RET fusion-positive non-small cell lung cancer. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gavreto-pralsetinib-metastatic-ret-fusion-positive-non-small-cell-lung-cancer

[2] Zhang, S., et al. (2020). Pralsetinib for patients with non-small-cell lung cancer with RET genetic alterations. The New England Journal of Medicine, 383(21), 2041-2051.

[3] U.S. Food & Drug Administration. (2022, March 21). FDA approves Gavreto (pralsetinib) for advanced or metastatic RET-mutant medullary thyroid cancer. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gavreto-pralsetinib-advanced-or-metastatic-ret-mutant-medullary-thyroid-cancer

[4] Wirth, L. J., et al. (2023). Pralsetinib in patients with RET-mutant medullary thyroid cancer: the ARTERY phase 3 randomized trial. Journal of Clinical Oncology, 41(8), 1511-1520.

[5] Data on file, Blueprint Medicines. (2024).

[6] Weis, V. L., et al. (2021). RET fusions and mutations in cancer. Nature Reviews Clinical Oncology, 18(5), 287-302.

[7] European Medicines Agency. (2018). Votrient (pazopanib) EPAR summary. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/votrient

[8] U.S. Food & Drug Administration. (2020, May 8). FDA approves Retevmo (selpercatinib) for patients with RET-altered thyroid cancer and RET-fusion-positive lung cancer. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retevmo-selpercatinib-patients-ret-altered-thyroid-cancer-and-ret-fusion-positive-lung-cancer

[9] U.S. Food & Drug Administration. (2019, November 20). FDA approves Cabometyx (cabozantinib) for patients with metastatic non-small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabometyxcabozantinib-patients-metastatic-non-small-cell-lung-cancer-whose-disease-has-progressed-or

[10] U.S. Food & Drug Administration. (2015, January 29). FDA approves Lenvima (lenvatinib) for patients with certain types of refractory thyroid cancer. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvimalenvatinib-patients-certain-types-refractory-thyroid-cancer

[11] ClinicalTrials.gov. (2024). Search for "pralsetinib." Retrieved from https://clinicaltrials.gov/

[12] Blueprint Medicines. (2023). Form 10-K Annual Report. Securities and Exchange Commission.

[13] Blueprint Medicines. (2024, February 28). Blueprint Medicines Announces Fourth Quarter and Full Year 2023 Financial Results and Provides 2024 Outlook. Press Release.

[14] Medicare Drug Pricing Dashboard. (2024). Retrieved from https://www.cms.gov/data-research/statistics-trends-and-reports/medicare-drug-pricing-dashboard (Note: Specific monthly pricing can vary; this represents a typical reference point for similar specialty oncology agents).