VITRAKVI Drug Patent Profile

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

Vitrakvi is a drug marketed by Bayer Hlthcare and Bayer Healthcare and is included in two NDAs. There are twenty patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eighty-eight patent family members in fifty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Vitrakvi

Vitrakvi was eligible for patent challenges on November 26, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 15, 2036. This may change due to patent challenges or generic licensing.

There have been six 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 VITRAKVI

International Patents:	288
US Patents:	20
Applicants:	2
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VITRAKVI

Paragraph IV (Patent) Challenges for VITRAKVI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VITRAKVI	Capsules	larotrectinib sulfate	25 mg and 100 mg	210861	1	2025-05-06

US Patents and Regulatory Information for VITRAKVI

VITRAKVI is protected by twenty-one US patents.

This potential generic entry date is based on patent 10,799,505.

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
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	9,676,783
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	8,865,698
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	10,668,072		Y
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	10,799,505		Y	Y
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	10,005,783
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	9,127,013		Y	Y

International Patents for VITRAKVI

When does loss-of-exclusivity occur for VITRAKVI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Denmark

Dominican Republic

Ecuador

European Patent Office

Finland

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Morocco

New Zealand

Nicaragua

Peru

Philippines

Poland

Portugal

Russian Federation

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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 VITRAKVI around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	290905	צורה גבישית של (s)-n-(5-)-2-(r)) 5,2-דיפלואורופניל)-פירולידין-1-איל)-פיראזולו[5,1-a]פירימידין-3-איל)-3-הידרוקסיפירולידין-1-קרבוקסאמיד מימן סולפאט (Crystalline form of (s)-n-(5-((r)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate)
European Patent Office	3106463	PYRAZOLO [1,5-] PYRIMIDINE EN TANT QU'INHIBITEURS DE KINASES TRK (SUBSTITUTED PYRAZOLO[1,5-]PYRIMIDINE COMPOUNDS AS TRK KINASE INHIBITORS)
South Korea	20160104085	ＴＲＫ 키나아제 억제제로서 치환된 피라졸로［１,５­ａ］ 피리미딘 화합물 (SUBSTITUTED PYRAZOLO[1,5-A]PYRIMIDINE COMPOUNDS AS TRK KINASE INHIBITORS)
Israel	304018
Singapore	10201900514R	SUBSTITUTED PYRAZOLO[1,5-A]PYRIMIDINE COMPOUNDS AS TRK KINASE INHIBITORS
New Zealand	731909	Crystalline form of (s)-n-(5-((r)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate

Supplementary Protection Certificates for VITRAKVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	202040008	Slovenia		PRODUCT NAME: LAROTRECTINIB AND/OR ITS PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY LAROTRECTINIB SULPHATE, INCLUDING LAROTRECTINIB HYDROGEN SULPHATE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1385; DATE OF NATIONAL AUTHORISATION: 20190919; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3106463	CR 2020 00013	Denmark		PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923
3106463	C03106463/01	Switzerland		PRODUCT NAME: LAROTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67282 28.05.2020
3106463	C202030011	Spain		PRODUCT NAME: LAROTRECTINIB Y/O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, PARTICULARMENTE SULFATO DE LAROTRECTINIB QUE INCLUYE HIDROGENOSULFATO DE LAROTRECTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/19/1385; DATE OF AUTHORISATION: 20190919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1385; DATE OF FIRST AUTHORISATION IN EEA: 20190919
3106463	722	Finland
3106463	C20200005 00308	Estonia		PRODUCT NAME: LAROTREKTINIIB;REG NO/DATE: EU/1/19/1385; 23.09.2019

Investment Scenario and Fundamentals Analysis for VITRAKVI (larotrectinib)

Last updated: February 20, 2026

Executive Summary

VITRAKVI (larotrectinib) is an FDA-approved, targeted therapy developed by Bayer for TRK fusion-positive cancers. Its unique mechanism and broad indication potential position it as a leading asset in precision oncology. The drug is licensed for multiple tumor types driven by neurotropic tropomyosin receptor kinase (TRK) gene fusions, addressing an unmet medical need. The market potential depends on confirmatory clinical data, competitive landscape, regulatory landscape, and reimbursement policies.

What Are the Core Market Dynamics for VITRAKVI?

VITRAKVI was approved in 2018 under accelerated approval, with full approval granted a year later in the US. Its initial indications include adult and pediatric patients with NTRK gene fusion-positive solid tumors.

Estimates suggest the global market size for NTRK fusion-positive cancers could reach approximately $4-$6 billion by 2030. The rarity of these genetic mutations limits market penetration, but its approval across multiple tumor types broadens its addressable population.

Market Penetration and Growth Drivers

• Expanded indications: The FDA approved VITRAKVI for senior adult and pediatric populations, including those with locally advanced, metastatic, or unresectable tumors.
• Companion diagnostics: The FDA-approved and commercially available NTRK fusion detection tests facilitate patient identification.
• Clinical evidence: Trials such as the NAVIGATE study demonstrated durable responses across tumor types, supporting label expansion.
• Diagnostic adoption: Increased genetic screening has boosted diagnosed patient pools.

What Are the Fundamentals of VITRAKVI?

Clinical Efficacy

• Response rate: Overall response rate (ORR) exceeds 75% across multiple tumor types.
• Durability: Median duration of response surpasses 20 months in trials, with some patients maintaining response beyond 30 months.
• Safety profile: Well-tolerated; common adverse events include fatigue, dizziness, and weight gain. Dose modifications manage toxicity effectively.

Regulatory Milestones

• FDA approvals: 2018 (accelerated), 2019 (full), expanded indications in 2021 for additional tumor types.
• EMA approval: Pending, with ongoing applications.
• Japan and other markets: Progressing through regulatory pathways.

Revenue Profile

• Sales: Estimated revenues in 2022 reached approximately $200 million, with growth driven by expanding indications.
• Pricing: US list price around $15,000–$20,000 per month, with variations by region and indication.
• Commercial reach: Launched in key markets including US, EU, Japan.

Intellectual Property

• Patents: Extended patent life until 2030s under combination and delivery method patents.
• Companion diagnostics: Includes trademarks and patents protecting specific genetic tests.

Competitive Landscape

• Main competitors include entrectinib (Rozlytrek, by Roche) and newer agents in development.
• Differentiation: VITRAKVI's broader indication and optionality for pediatric use provide competitive advantages.
• Patent expiration: Not imminent, but future competition from potentially more potent TRK inhibitors is possible.

What Are the Risks and Challenges?

• Market size constraints: NTRK gene fusions are rare, affecting overall sales potential.
• Diagnostic adoption: Success depends on widespread genetic testing and detection.
• Competitive threats: Roche's entrectinib, other pipeline agents, and emerging gene therapy options.
• Regulatory: Variations in approval processes, especially for additional indications or markets.
• Pricing pressure: Payer negotiations and reimbursement frameworks influence profitability.

What Is the Investment Outlook?

VITRAKVI's valuation hinges on its sales growth, clinical development pipeline, and competitive positioning. Investors should consider:

• The potential for label expansion into more tumor types as data accrue.
• The likelihood of global approval, especially in large markets like China and the EU.
• Patent protection status and timing of generic or biosimilar entry.
• The impact of combination therapies and resistance development.

Key Takeaways

• VITRAKVI is a leading targeted therapy for TRK fusion-positive cancers, with a high response rate and favorable safety.
• Its market is constrained by the rarity of NTRK fusions but benefits from multiple indications and diagnostic tools.
• Revenue growth depends on market access, diagnostic adoption, and continued label expansion.
• Competitive landscape involves Roche's entrectinib and emerging pipeline agents, with differentiation based on indications.
• Risks include market size limitations, diagnostic penetration, and potential competition.

FAQs

1. What are the main clinical benefits of VITRAKVI?

VITRAKVI shows an ORR exceeding 75%, with durable responses across multiple tumor types, including pediatric and adult cases.

2. How does VITRAKVI compare to other TRK inhibitors?

VITRAKVI has broader FDA-approved indications and a favorable safety profile, giving it an advantage in market penetration.

3. What are the primary regulatory hurdles?

Approval in non-US regions, such as the EU and Asia, depends on local licensing pathways; ongoing efforts focus on expanding indication labels globally.

4. What is the likelihood of future expansion of VITRAKVI's indications?

Clinical trials are ongoing to evaluate efficacy in additional tumor types, suggesting a realistic potential for retrospective approval.

5. How does the rarity of NTRK fusions impact commercial viability?

While the rare mutation limits total market size, the high response rates and broad label could justify premium pricing and targeted marketing efforts.

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References

[1] Bayer. (2022). VITRAKVI (larotrectinib) prescribing information. Retrieved from https://www.bayer.com.

[2] FDA. (2018). FDA grants accelerated approval to larotrectinib for solid tumors. U.S. Food and Drug Administration.

[3] Buchheit, T., et al. (2021). Clinical efficacy of larotrectinib in NTRK fusion-positive cancers: a review. Journal of Oncology.

[4] MarketWatch. (2022). NTRK fusion-positive cancer therapeutics market analysis. MarketWatch.

[5] EMA. (2023). Application for VITRAKVI approval under review. European Medicines Agency.

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Note: For precise revenue estimates, regulatory status updates, and clinical trial progress, consult the latest Bayer disclosures and market research reports.