Larotrectinib sulfate - Generic Drug Details

What are the generic sources for larotrectinib sulfate and what is the scope of patent protection?

Larotrectinib sulfate is the generic ingredient in one branded drug marketed by Bayer Hlthcare and Bayer Healthcare, and is included in two NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Larotrectinib sulfate has two hundred and eighty-seven patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for larotrectinib sulfate

International Patents:	287
US Patents:	20
Tradenames:	1
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	4
Patent Applications:	583
DailyMed Link:	larotrectinib sulfate at DailyMed

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

Dosage:

CAPSULE;ORAL

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 larotrectinib sulfate

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Children's Oncology Group	Phase 2
National Cancer Institute (NCI)	Phase 2

See all larotrectinib sulfate clinical trials

Pharmacology for larotrectinib sulfate

Drug Class	Kinase Inhibitor
Mechanism of Action	Tropomyosin Receptor Kinases Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for larotrectinib sulfate

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for LAROTRECTINIB SULFATE

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 larotrectinib sulfate

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			Y
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes
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

International Patents for larotrectinib sulfate

Country	Patent Number	Title	Estimated Expiration
Ukraine	125026	РІДКІ КОМПОЗИЦІЇ (S)-N-(5-((R)-2-(2,5-ДИФТОРФЕНІЛ)ПІРОЛІДИН-1-ІЛ)ПІРАЗОЛО[1,5-a]ПІРИМІДИН-3-ІЛ)-3-ГІДРОКСИПІРОЛІДИН-1-КАРБОКСАМІДУ (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)
Russian Federation	2666367	ЗАМЕЩЕННЫЕ ПИРАЗОЛО[1,5-а]ПИРИМИДИНОВЫЕ СОЕДИНЕНИЯ КАК ИНГИБИТОРЫ ТРК КИНАЗЫ (SUBSTITUTED PYRAZOLO[1,5-A]PYRIMIDINE COMPOUNDS AS INHIBITORS OF TRK KINASE)
Taiwan	201625636	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
Ukraine	106054	ЗАМЕЩЕННЫЕ ПИРАЗОЛО[1,5-a]ПИРИМИДИНОВЫЕ СОЕДИНЕНИЯ КАК ИНГИБИТОРЫ ТРК-КИНАЗЫ;ЗАМІЩЕНІ ПІРАЗОЛО[1,5-a]ПІРИМІДИНОВІ СПОЛУКИ ЯК ІНГІБІТОРИ TРK-КІНАЗИ (Normal;heading 1;heading 2;heading 3;SUBSTITUTED IMIDAZO[1,5-a]PYRIDAZINE COMPOUNDS AS TRK KINASE INHIBITORS)
Mexico	386416
Argentina	108090	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

Supplementary Protection Certificates for larotrectinib sulfate

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

Market Dynamics and Financial Trajectory for LAROTRECTINIB SULFATE

Last updated: July 28, 2025

Introduction

LAROTRECTINIB SULFATE, marketed as Vitrakvi, is a groundbreaking targeted therapy developed by Bayer and Genentech/Roche for the treatment of tumors harboring NTRK gene fusions. As the first FDA-approved NTRK inhibitor, its regulatory approvals across major markets have significantly influenced its market trajectory. Understanding the evolving market dynamics and forecasting its financial prospects requires a comprehensive analysis of clinical efficacy, regulatory landscape, competitive environment, and patent protections.

Pharmacological Profile and Clinical Efficacy

LAROTRECTINIB SULFATE is distinguished by its high potency and specificity toward neurotrophic receptor tyrosine kinase (NTRK) gene fusions, which are oncogenic drivers present in a variety of solid tumors. Clinical trials, notably the STARTRK-2 study, demonstrated impressive response rates—up to 75% in adult patients with NTRK fusion-positive cancers—including gliomas, colon, and lung cancers (source: [1]).

The drug’s efficacy, minimal off-target effects, and durable responses have cemented its status as a first-line targeted therapy for this rare genetic mutation, expanding its potential market. However, its utility hinges on the accurate molecular diagnosis of NTRK fusions, necessitating advanced diagnostic infrastructure, which may limit early adoption in some regions but is poised for growth as molecular testing becomes more widespread.

Regulatory Landscape and Market Penetration

Since its initial FDA approval in November 2018 for adult patients with NTRK fusion-positive solid tumors, LAROTRECTINIB has gained subsequent approvals in numerous jurisdictions, including the European Union, Japan, and China. The accelerated approval pathways reflect its high unmet clinical need and exceptional efficacy profile.

Regional regulatory approvals influence market dynamics markedly. The U.S. market remains the most accessible, bolstered by robust reimbursement frameworks, whereas approval delays or limitations in emerging markets are barriers to rapid adoption. Additionally, the orphan drug designation confers market exclusivity duration—7 years in the U.S.—further impacting competitive dynamics.

Competitive Environment

While LAROTRECTINIB is currently the sole FDA-approved NTRK inhibitor, its main competitor, entrectinib (Rozlytrek), developed by AbbVie and Genentech, provides an alternative with similar efficacy profiles. However, differences in side-effect profiles, central nervous system penetration, and approved indications influence physician prescribing practices.

Upcoming competitors include next-generation NTRK inhibitors designed to circumvent resistance mechanisms—particularly acquired mutations in NTRK that diminish drug efficacy. Several biotech firms are investing in such agents, which could disrupt LAROTRECTINIB's market dominance if proven superior in overcoming resistance.

Resistance and Market Challenges

Despite promising data, resistance development remains a significant challenge. NTRK fusions can acquire mutations such as solvent-front or gatekeeper mutations, leading to secondary resistance. Addressing this has spurred development of next-generation inhibitors tailored for resistant tumors.

Another challenge is the relatively small patient population—NTRK fusions occur in approximately 1% of all solid tumors—limiting market size but commanding premium pricing due to high unmet need.

Reimbursement policies are critical; high drug prices—often exceeding $100,000 per year—necessitate favorable health-economic evaluations to secure payer coverage. Price negotiations and value-based agreements will influence revenue potential.

Forecasted Financial Trajectory

Current Revenue and Penetration

LAROTRECTINIB’s global sales approximated $250 million in 2021, with rapid growth driven by widened indications and geographies ([2]). The drug’s data indicates a compound annual growth rate (CAGR) of approximately 30% since initial launch, although growth may plateau as market penetration saturates and resistance emerges.

Market Expansion Opportunities

• Expanded Indications: Ongoing trials explore efficacy in pediatric populations and wider tumor types, which could substantially enlarge market access.
• Diagnostic Integration: As molecular testing becomes a standard component of oncology diagnostics, identification rates of NTRK fusions—and thus eligible patients—are projected to increase, potentially quadrupling the target population over the next decade.

Long-Term Revenue Outlook

Based on current trends, global sales could approach $1 billion by 2027, assuming sustained growth, broader indications, and minimal resistance issues. However, this assumes no major competitive disruptions or regulatory setbacks.

Risks

• Emergence of Resistance: Resistance mechanisms could reduce long-term efficacy, necessitating combination therapies or new agents.
• Pricing and Reimbursement: Variations in healthcare reimbursement policies could limit profit margins.
• Market Competition: Arrival of next-generation inhibitors and biosimilars (if applicable) could exert downward pressure on pricing.

Intellectual Property and Market Exclusivity

Patent protections extend into the late 2020s or early 2030s, providing a temporal window for revenue maximization. Additionally, orphan drug status enhances market exclusivity, incentivizing sustained marketing efforts.

Conclusion

LAROTRECTINIB SULFATE epitomizes a transformative approach in precision oncology with robust clinical data underpinning its market potential. Its future financial trajectory depends heavily on expanding indications, sustained regulatory support, overcoming resistance, and optimizing diagnostic pathways. While current momentum is promising, addressing resistance mechanisms and fostering competitive innovation will be critical for maintaining its market position and maximizing long-term revenues.

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Key Takeaways

• Market Potential is Expanding: Growing approvals and broader diagnostic adoption position LAROTRECTINIB as a lucrative niche-focused asset, potentially exceeding $1 billion in global sales by 2027.
• Resistance Monitoring is Critical: Secondary mutations threaten long-term efficacy, prompting ongoing development of next-generation inhibitors.
• Reimbursement and Pricing Strategies Matter: High prices necessitate strong health economics and payer negotiations to secure market access.
• Diagnostic Infrastructure is a Growth Driver: Enhanced molecular testing will improve patient identification and expand the eligible population.
• Competitive Landscape Will Evolve: Entry of new agents targeting resistant NTRK mutations could reshape market shares, emphasizing the need for continual innovation.

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FAQs

1. What makes LAROTRECTINIB SULFATE unique compared to other cancer therapies?
LAROTRECTINIB is the first FDA-approved gene fusion-targeted therapy, designed specifically for NTRK fusion-positive tumors. Its high specificity and ability to induce durable responses across multiple tumor types distinguish it within precision oncology.

2. How does resistance to LAROTRECTINIB develop, and what are the solutions?
Resistance often arises from secondary mutations within the NTRK kinase domain, such as solvent-front and gatekeeper mutations. Developing next-generation inhibitors tailored to overcome these mutations is the primary solution.

3. What is the potential for LAROTRECTINIB in pediatric populations?
Studies are ongoing to evaluate safety and efficacy in pediatric patients. Success could significantly expand the drug’s market, as NTRK fusions are present in certain pediatric tumors like infantile fibrosarcoma.

4. How do regulatory and reimbursement policies influence its market?
Regulatory approvals facilitate sales expansion, while reimbursement policies directly impact patient access and profitability. Favorable policies accelerate uptake, whereas restrictive payers can limit revenue.

5. What is the competitive advantage of LAROTRECTINIB over other NTRK inhibitors?
LAROTRECTINIB’s proven efficacy, CNS penetration, and broader indication approvals underpin its competitive strength. Its established safety profile and early market entry also contribute to sustained market presence.

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Sources:

1. Drilon, A., et al. (2018). "Efficacy of Larotrectinib in TRK Fusion-Positive Cancers." The New England Journal of Medicine [1].
2. Bayer. (2022). "Vitrakvi (Larotrectinib) Prescribing Information."
3. FDA. (2018). "Approval Letter for Larotrectinib."
4. IQVIA. (2022). "Oncology Drug Sales and Market Analyses."