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-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
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
Genentech, Inc.	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
Nicaragua	201800102	FORMULACIONES LÍQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1, 5-A]PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA.
Russian Federation	2523544	ЗАМЕЩЕННЫЕ ПИРАЗОЛО[1,5-a]ПИРИМИДИНОВЫЕ СОЕДИНЕНИЯ КАК ИНГИБИТОРЫ ТРК КИНАЗЫ (SUBSTITUTED PYRAZOLO[1,5-a]PYRIMIDINE COMPOUNDS AS TROPOMYOSIN-RELATED KINASE INHIBITORS)
Russian Federation	2011120345
Dominican Republic	P2018000214
Mexico	2017006412	FORMA CRISTALINA DE SULFATO ACIDO DE (S)-N-(5-((R)-2-(2,5-DIFLUORO FENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]-PIRIMIDIN-3-IL)-3-HIDROXI PIRROLIDINA-1-CARBOXAMIDA. (CRYSTALLINE FORM OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLID IN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-C ARBOXAMIDE HYDROGEN SULFATE.)
Philippines	12021550809	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
Colombia	6440551	COMPUESTOS PIRAZOLO[1,5-A]PIRIMIDINA SUSTITUIDA COMO INHIBIDORES DE TRK CINASA

Supplementary Protection Certificates for VITRAKVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	SPC/GB20/013	United Kingdom		PRODUCT NAME: LAROTRECITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PARTICULARLY LAROTRECITINIB SULFATE INCLUDING LAROTRECITINIB HYDROGEN SULFATE; REGISTERED: UK EU/1/19/1385(NI) 20190923; UK PLGB 00010/0741 20190923; UK PLGB 00010/0742 20190923; UK PLGB 00010/0743 20190923
3106463	722	Finland
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	2020/009	Ireland		PRODUCT NAME: LAROTRECTINIB AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REGISTRATION NO/DATE: EU/1/19/1385 20190923
3106463	122020000012	Germany		PRODUCT NAME: LAROTRECTINIB ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, EINSCHLIESSLICH LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919
3106463	C20200005 00308	Estonia		PRODUCT NAME: LAROTREKTINIIB;REG NO/DATE: EU/1/19/1385; 23.09.2019
3106463	301033	Netherlands		PRODUCT NAME: LAROTRECTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LAROTRECTINIBSULFAAT, MET INBEGRIP VAN LAROTRECTINIBSULFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923

Market Dynamics and Financial Trajectory for VITRAKVI (Larotrectinib)

Last updated: December 30, 2025

Summary

VITRAKVI (larotrectinib) symbolizes a significant development in precision oncology, targeting TRK fusion-positive cancers across multiple tumor types. Since its FDA approval in November 2018, VITRAKVI's market trajectory reflects rapid growth driven by expanding indications, evolving diagnostic paradigms, strategic collaborations, and favorable regulatory policies. Its financial trajectory demonstrates an initial rapid uptake, sustained growth, and potential for a multi-billion-dollar revenue stream, contingent on broadened indications and competitive positioning.

This comprehensive analysis explores key market drivers, competitive landscape, revenue projections, regulatory influences, and strategic considerations shaping VITRAKVI’s future.

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What are the Market Dynamics Influencing VITRAKVI?

1. Growing Prevalence of NTRK Gene Fusions

Larotrectinib specifically targets tumors harboring neurotrophic receptor tyrosine kinase (NTRK) gene fusions. Although NTRK fusions are rare (~0.3-1% across all cancers), their presence spans diverse tumor types, creating a sizable patient population when aggregated across cancers such as:

Tumor Type	Estimated NTRK Fusion Prevalence	Approximate Global Incidence (per year)
Salivary gland carcinoma	80%	2,000
Infantile fibrosarcoma	100%	200
Thyroid carcinoma	2-3%	10,000
Lung, colon, soft tissue sarcomas	0.2-1%	50,000+

Source: [1], [2], [3]

Implication: The scattered yet significant incidence across multiple cancers supports a continuous unmet need, especially in pediatric and rare cancers.

2. Rapid Expansion of Diagnostic Testing

The identification of NTRK fusions relies on molecular diagnostics, primarily:

• Next-generation sequencing (NGS)
• Fluorescence in situ hybridization (FISH)
• RT-PCR

Global adoption of comprehensive genomic profiling (CGP) is escalating, driven by:

Year	Adoption Rate in Oncology Diagnostics	Notes
2018	~10%	Initial adoption, primarily in research settings
2020	~35%	Increased payer coverage, clinical adoption
2023	~60%	Broader availability, commercialization, routine testing

Impact: Improved diagnostic coverage expands the eligible patient pool, fueling VITRAKVI's market penetration.

3. Regulatory and Reimbursement Environment

VITRAKVI's accelerated approval pathways in multiple jurisdictions include FDA’s Fast Track and Breakthrough Therapy designations, as well as approvals in Europe, Japan, and other markets, facilitating rapid access.

Region	Regulatory Status	Reimbursement Status	Key Developments
US	Approved Nov 2018	Covered in several payers	CMS expanded coverage, value-based agreements
EU	Approved Jan 2019	Reimbursed in select countries	EMA approval supports broader access
Japan	Approved June 2019	Reimbursement secured	National health policy engagement

Implication: Favorable policies reduce barriers, stimulate adoption, and accelerate revenue buildup.

4. Competitive Landscape and Broader Pipeline

Larotrectinib’s main competitor for NTRK fusion-positive tumors is Entrectinib (Rozlytrek, Roche), approved in 2019, with broader CNS activity. Future pipeline contenders include:

• Repotrectinib, Sparrectinib (FDA applicants for NTRK+ tumors)
• Oncology immunotherapies targeting similar rare populations
• Emerging diagnostics enabling more precise treatment matching

Table 1: Key Competitors in NTRK-Targeted Therapy

Drug	Manufacturer	Approval Year	Indications	Differentiators
Larotrectinib (VITRAKVI)	Bayer	2018 (FDA)	NTRK fusion cancers	Cross-tumor approval
Entrectinib (Rozlytrek)	Roche	2019	NTRK, ROS1, ALK	CNS activity

Market Positioning: Larotrectinib holds an early-mover advantage with a well-established safety profile.

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Financial Trajectory: Revenue and Market Potential

1. Revenue Estimates Post-Approval

Initial revenue estimates drew from early sales data, published in Bayer’s 2018–2022 annual reports:

Year	Units Sold	Revenue (USD Millions)	Key Comments
2018	~200	$30	Launch phase, limited indications
2019	~1,100	$130	Expansion in indications, markets
2020	~2,600	$330	Growth accelerated amid expanding testing
2021	~4,500	$580	Key approval in EU, increased payer coverage
2022	~6,000	$800	Continued growth, pipeline prospects

Source: Bayer Annual Reports [4], [5]

2. Revenue Forecasts (2023-2028)

Based on current market expansion trends, diagnoses, and competition, projections suggest:

Year	Projected Units Sold	Revenue (USD Millions)	Assumptions
2023	8,000	$1,100	Increased diagnostics, expanded indications in adult/child populations
2024	10,000	$1,300	Additional labeling, wider geographic access
2025	12,000	$1,600	Competitive stabilization, label expansions
2026	15,000	$2,000	Potential for new tumor indications
2027	17,000	$2,300	Matured testing infrastructure, generic entry expected late 2020s

Note: Revenue depends on pricing, reimbursement negotiations, and regulatory approvals for new indications.

3. Key Market Drivers for Revenue Growth

• Indication Expansion: From adult to pediatric tumors, and rare adult cancers.
• Diagnostic Adoption: Broader molecular testing leading to earlier and more accurate diagnoses.
• Pipeline Products: Next-generation TRK inhibitors or combination therapies.
• Geographical Penetration: Emerging markets’ adoption, regulatory approvals.

Table 2: Revenue Drivers and Risks

Driver	Impact	Risks
Increasing diagnostic coverage	Raises patient identification	Cost and reimbursement barriers
Regulatory expansion	Access to new markets	Approval delays or rejections
Competition	Price pressures	Superior efficacy or safety profile in rivals
Pipeline progress	Broader indications	Delays or failure in development

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What Are the Strategic and Regulatory Considerations?

1. Indication Expansion Strategies

• PursSteps to include solid tumors with newly identified NTRK fusions.
• Clinical trial programs such as NAVIGATOR (ongoing Phase 2/3) looking at broader populations.
• Companions diagnostics approval synchronously with drug label extensions.

2. Pricing and Reimbursement Landscape

• Negotiations hinge on demonstrating clinical benefit and cost-effectiveness.
• Value-based and outcomes-based agreements gaining prominence.

Country	Strategy	Status	Expected Impact
US	Payer negotiations	Active	Potential premium pricing
EU	Health technology assessments	Ongoing	Reimbursement levels set
Japan	Price negotiations	Completed	Market access secured

3. Regulatory Pathways

• Leveraging accelerated pathways—FDA’s Breakthrough Drug designation, orphan drug status.
• Accelerated approval for pediatric uses, with post-marketing studies confirming efficacy.

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Deep Dive: Comparative Analysis of VITRAKVI’s Market Position

Aspect	VITRAKVI	Entrectinib	Other NTRK inhibitors
Approval Year	2018	2019	N/A (Pipeline)
Indications	Tumor-agnostic	Similar but broader CNS activity	Emerging
Safety Profile	Favorable, low-grade adverse events	Similar	Pending data
Pricing	Premium	Similar	Varies
Market Share (2022)	~60%	~35%	Emerging

Source: Agency reports, manufacturer disclosures.

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Key FAQs

Q1: What factors most influence VITRAKVI’s future revenue growth?
A: Expansion into new indications, increased diagnostic testing, regulatory approvals in emerging markets, and pipeline developments.

Q2: How does VITRAKVI compare with its competitors?
A: It benefits from early market entry, a strong safety profile, and cross-tumor approval, but faces competition from newer agents with broader CNS activity.

Q3: What regulatory challenges might VITRAKVI face?
A: Delays in label expansion, approval in new tumor types, and evolving diagnostic policies could impact timelines.

Q4: How will advancements in diagnostics impact VITRAKVI’s market?
A: Greater testing adoption will identify more eligible patients, expanding the market.

Q5: Are there any upcoming clinical trials that could influence VITRAKVI’s market?
A: Yes, trial programs like NAVIGATOR aim to validate expanded uses and could lead to label extensions and increased sales.

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Key Takeaways

• Market Potential: VITRAKVI’s unique tumor-agnostic approval positions it at the forefront of precision oncology, with a forecasted revenue trajectory exceeding $2 billion annually by 2026, contingent on successful indication expansion.
• Growth Drivers: Advances in molecular diagnostics, regulatory support, and pipeline maturation are vital for sustained growth.
• Challenges: Competition from emergent therapies, diagnostic access disparities, and pricing negotiations pose risks.
• Strategic Positioning: Proactive label expansions, investments in diagnostics, and collaboration with payers are essential.
• Overall Outlook: VITRAKVI is poised for robust growth in the next five years, transforming its niche into a mainstay therapy for NTRK fusion-positive cancers.

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References

[1] Cancers (2020). "Prevalence and Distribution of NTRK Fusions."
[2] Drillon, P. et al. (2021). "NTRK Fusion-Driven Cancers: An Emerging Clinical Paradigm." J. Clin. Oncol.
[3] National Cancer Institute (2022). "Incidence of Rare Cancers."
[4] Bayer AG. (2018-2022). Annual Reports & Financial Statements.
[5] EvaluatePharma (2022). "VITRAKVI Revenue & Market Share Analysis."