VITRAKVI Drug Patent Profile

Which patents cover Vitrakvi, 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-seven 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:	287
US Patents:	20
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	5
Patent Applications:	1,472
Drug Prices:	Drug price information for VITRAKVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VITRAKVI
What excipients (inactive ingredients) are in VITRAKVI?	VITRAKVI excipients list
DailyMed Link:	VITRAKVI at DailyMed

See drug prices for VITRAKVI

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

Constraining patent/regulatory exclusivity:

10,799,505

NDA:

210861

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

10,137,127

NDA:

211710

Dosage:

SOLUTION;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.

Recent Clinical Trials for VITRAKVI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Children's Oncology Group	Phase 2
Pfizer	Phase 2

See all VITRAKVI clinical trials

Pharmacology for VITRAKVI

Drug Class	Kinase Inhibitor
Mechanism of Action	Tropomyosin Receptor Kinases Inhibitors

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 and three FDA Regulatory Exclusivities.

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	9,782,414
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	9,127,013		Y	Y
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	10,799,505			Y
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	11,337,967
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	8,513,263		Y	Y
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	10,285,993

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
Singapore	11201808676R	METHODS OF TREATING PEDIATRIC CANCERS
Japan	2021169496	（Ｓ）−Ｎ−（５−（（Ｒ）−２−（２，５−ジフルオロフェニル）−ピロリジン−１−イル）−ピラゾロ［１，５−ａ］ピリミジン−３−イル）−３−ヒドロキシピロリジン−１−カルボキサミド硫酸水素塩の結晶形 (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)
Mexico	386416	FORMULACIONES LIQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA. (LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE)
South Korea	101784798
European Patent Office	3426250
European Patent Office	3372605	COMPOSÉS DE PYRAZOLO[1,5-A] PYRIMIDINE SUBSTITUÉS EN TANT QU'INHIBITEURS DE KINASES TRK (SUBSTITUTED PYRAZOLO[1,5-A]PYRIMIDINE COMPOUNDS AS TRK KINASE INHIBITORS)
Morocco	44610	FORMULATIONS LIQUIDES DE (S)-N-(5-((R)-2-(2,5-DIFLUOROPHÉNYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE

Supplementary Protection Certificates for VITRAKVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	2020C/507	Belgium		PRODUCT NAME: VITRAKVI - LAROTRECTINIB ET/OU SES SELS ACCEPTABLES EN PHARMACIE, EN PARTICULIER L'HYDROGENO SULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923
3106463	PA2020504	Lithuania		PRODUCT NAME: LAROTREKTINIBAS IR (ARBA) FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, YPAC LAROTREKTINIBO SULFATAS, ISKAITANT LAROTREKTINIBO VANDENILIO SULFATA; REGISTRATION NO/DATE: EU/1/19/1385 20190919
3106463	2090009-8	Sweden		PRODUCT NAME: LAROTRECTINIB,OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REG. NO/DATE: EU/1/19/1385 20190923
3106463	CA 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	C20200005 00308	Estonia		PRODUCT NAME: LAROTREKTINIIB;REG NO/DATE: EU/1/19/1385; 23.09.2019
3106463	20C1012	France		PRODUCT NAME: LAROTRECTINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SULFATE DE LAROTRECTINIB TEL QUE L'HYDROGENOSULFATE DE LAROTRECTINIB; NAT. REGISTRATION NO/DATE: EU/1/19/1385 20190923; FIRST REGISTRATION: DE - EU/1/19/1385 20190923

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: VITRAKVI

Last updated: July 27, 2025

Introduction

VITRAKVI (larotrectinib) represents a significant advancement in precision oncology, specifically targeting neurotrophic receptor tyrosine kinase (NTRK) gene fusions across diverse tumor types. Approved by the U.S. Food and Drug Administration (FDA) in August 2019, VITRAKVI exemplifies the shift towards tissue-agnostic cancer treatments, reshaping market expectations and clinical paradigms. This comprehensive analysis delineates the current market landscape, technical and regulatory trends, competitive positioning, and financial trajectories associated with VITRAKVI.

Market Introduction and Clinical Relevance

VITRAKVI's molecular mechanism centers on selectively inhibiting TRK fusion proteins resulting from NTRK gene rearrangements, which are implicated in approximately 1% of solid tumors. While rare, the therapeutic impact is profound due to the drug’s high response rate and durability of responses, as evidenced in clinical trials like COOL (NCT02576431). The tissue-agnostic approval underscores the importance of genetic profiling irrespective of tumor origin, unlocking a broader spectrum for targeted therapy deployment.

The global oncology market encompasses more than 30 million new cancer cases annually, with molecularly defined subpopulations expanding prospects for targeted treatments such as VITRAKVI. The drug's approval has spurred innovation and increased interest in genetic testing, shifting diagnostic paradigms toward comprehensive genomic profiling (CGP).

Market Dynamics

1. Epidemiology and Market Penetration

The incidence of NTRK gene fusions, although rare, varies across tumor types, including infantile fibrosarcoma, secretory breast carcinoma, and various adult solid tumors. Specific figures report NTRK fusion prevalence at approximately 0.3% to 1% in common adult cancers, rising in certain pediatric cancers. This rarity limits the direct patient population but is offset globally by increasing testing rates and expanding indications.

In established markets—primarily North America, Europe, and Asia-Pacific—market penetration hinges on diagnostic infrastructure, reimbursement policies, and clinician familiarity with molecular therapies. The FDA’s tissue-agnostic approval facilitated broader clinician adoption, while ongoing expansion into early-line settings could elevate consumption.

2. Competitive and Regulatory Landscape

VITRAKVI faces competition chiefly from other NTRK inhibitors like Bayer's entrectinib (Relyr), which gained FDA approval in August 2019, and the emerging pipeline of next-generation TRK inhibitors. While VITRAKVI was the first tissue-agnostic NTRK fusion therapy, the recent approvals of competing agents with comparable efficacy and differing safety profiles intensify the competitive landscape.

Regulatory barriers have generally declined for predictive diagnostics, with mandates for broader molecular profiling in oncology. However, reimbursement policies significantly influence market access, especially in countries with resource constraints. For example, in the U.S., Medicare and private insurers increasingly cover CGP tests, bolstering potential patient access.

3. Diagnostic Integration and Precision Oncology Trends

The shift towards routine comprehensive genomic profiling has been a catalyst for VITRAKVI’s growth. Next-generation sequencing (NGS) panels, including FoundationOne, Guardant360, and Tempus, detect NTRK fusions efficiently, enabling prompt therapeutic decision-making.

However, the challenge remains in standardizing biomarker testing, ensuring equitable access, and managing false negatives or limited tissue samples. Improving diagnostic turnaround times directly benefits market expansion, allowing timely interventions with VITRAKVI.

Financial Trajectory

1. Revenue Drivers

VITRAKVI's revenues have risen steadily since its launch, driven by increased indications, broader testing adoption, and expanding geographic reach. According to recent financial disclosures from its manufacturer, Bayer, the drug generated approximately €150 million (~$170 million) in global sales during 2022, reflecting initial uptake primarily in the U.S. and Europe (Bayer, 2022).

Revenue growth is expected to accelerate as the drug gains approval for earlier lines of therapy, including first-line treatments in NTRK-positive patients, and as indications extend into adult cancers with higher prevalence.

2. Market Expansion Strategies

Bayer has prioritized strategic collaborations, clinical trials, and patient education to bolster market share. Entry into emerging markets with developing healthcare infrastructure represents a significant growth lever. Additionally, VITRAKVI’s clinical trial data supports its use across multiple tumor types, raising the potential for label extensions, which directly translate into revenue expansion.

3. Pricing and Reimbursement Outlook

Pricing strategies for VITRAKVI reflect its targeted therapy status. The initial dosing cost approximates $16,000 per month, aligning with other precision oncology drugs. Reimbursement success hinges on demonstrating cost-effectiveness via durability of response and improved survival outcomes.

Health technology assessments (HTAs) in key markets influence access; increasing stakeholder engagement and health economic evaluations will be critical for sustainable market penetration. The global trend toward value-based pricing aligned with clinical benefit augments the potential for premium pricing models.

4. Competitive and Pipeline Considerations

VITRAKVI faces imminent competition from patent-protected innovations and next-generation agents with improved safety profiles or crossing into additional indications. Patent expiry timelines, typically 10-12 years from approval, will influence future revenue streams. Bayer's ability to innovate, secure new approvals, and deploy effective lifecycle management strategies will shape the drug's long-term financial trajectory.

Pipeline and Future Outlook

Expanding indications, such as first-line therapy in NTRK fusion-positive cancers, and adjunctive uses in combination regimens, hold promise for cross-market growth. Ongoing clinical trials in specific subpopulations—like pediatric and adolescent patients—may further broaden market access.

Emerging diagnostics with higher sensitivity and multiplex testing will likely enhance identification rates, supporting higher prescription volumes. Advances in liquid biopsy techniques facilitate non-invasive detection, further integrating VITRAKVI into routine care pathways.

Market Challenges and Risks

Key obstacles include the rarity of NTRK fusions, which limits the total addressable market, and challenges in universal diagnostic access. Safety profiles and resistance mechanisms, such as acquired mutations leading to TRK kinase domain mutations, could impact future efficacy and market share. Moreover, healthcare policy shifts and pricing pressures may affect reimbursement and revenue sustainability.

Key Takeaways

• Strategic Expansion: VITRAKVI’s success depends on extending indications, integrating with diagnostic advances, and fostering global access. Clinical trial data supporting expanded use will be pivotal.

• Diagnostic-Driven Growth: The increasing adoption of CGP tests enhances early detection, expanding the identifiable patient population, and enabling timely therapy initiation.

• Competitive Dynamics: Rapid pipeline development and the entry of rival agents underscore the importance of innovation, lifecycle management, and patent protection.

• Financial Outlook: Steady revenue growth is anticipated, with potential acceleration through broader indications and geographic expansion. Price optimization and reimbursement strategies remain critical.

• Market Risks: Limited prevalence of NTRK fusions constrains market size, while resistance mechanisms and healthcare policy factors pose ongoing challenges.

Conclusion

VITRAKVI’s market trajectory exemplifies the rise of tissue-agnostic targeted therapies within oncology’s evolving landscape. Its financial success hinges on expanding clinical evidence, navigating diagnostic and regulatory pathways, and outperforming competition through innovation. While the rarity of NTRK fusions constrains volumetric potential, strategic market positioning and sustained clinical development can secure its role as a foundational therapy in precision oncology.

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FAQs

1. What are the primary factors influencing VITRAKVI’s market growth?
Market growth is driven by increased detection of NTRK fusions through comprehensive genomic testing, expanding indications, global approval adoption, and clinical evidence supporting efficacy across tumor types.

2. How does VITRAKVI differentiate from its competitors?
VITRAKVI's tissue-agnostic label, early FDA approval, proven durable responses, and safety profile distinguish it from competitors. Its focus on molecular targeting rather than tumor origin enhances its appeal.

3. What are the main challenges in scaling VITRAKVI's market?
Limited prevalence of NTRK fusions restricts the overall patient pool. Barriers include diagnostic access, reimbursement policies, and potential resistance development.

4. How is the impact of resistance mechanisms on VITRAKVI’s long-term viability addressed?
Research into next-generation TRK inhibitors aims to overcome resistance mutations. Combination therapies and continual molecular monitoring are strategic responses.

5. What future opportunities exist for VITRAKVI in oncology?
Potential expansion into earlier treatment lines, pediatric indications, and combination regimens provides avenues for growth. Advances in liquid biopsy diagnostics may also increase application scope.

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References

1. Bayer. (2022). VITRAKVI (larotrectinib): Annual financial report.
2. U.S. Food and Drug Administration. (2019). FDA approves larotrectinib for NTRK fusion-positive cancers.
3. ClinicalTrials.gov. (2023). COOL trial (NCT02576431).
4. Bayer. (2022). Oncology pipeline and strategic updates.