larotrectinib sulfate - Profile

What are the generic drug sources for larotrectinib sulfate and what is the scope of freedom to operate?

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.

Summary for larotrectinib sulfate

International Patents:	287
US Patents:	20
Tradenames:	1
Applicants:	2
NDAs:	2

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

Constraining patent/regulatory exclusivity:

10,799,505

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

10,137,127

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.

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 Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	10,047,097
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	8,865,698
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	10,005,783
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	9,782,414
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	10,285,993
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	11,974,998
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	11,337,967

International Patents for larotrectinib sulfate

Country	Patent Number	Title	Estimated Expiration
South Korea	102805232
Costa Rica	20180501
Israel	252270	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)
Serbia	65987
Hungary	E057625
Georgia, Republic of	AP202114914
Australia	2020203606

Supplementary Protection Certificates for larotrectinib sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	11/2020	Austria		PRODUCT NAME: LAROTRECTINIB UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFAT, EINSCHLIESSLICH LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923
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	C03106463/01	Switzerland		PRODUCT NAME: LAROTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67282 28.05.2020
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	PA2020504,C3106463	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	722	Finland
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

Investment and Fundamentals Analysis of Larotrectinib Sulfate

Last updated: February 19, 2026

Larotrectinib sulfate (Vitrakvi) is a selective tropomyosin receptor kinase (TRK) inhibitor approved for treating TRK fusion-positive solid tumors. Its market approval, receptor specificity, and clinical data impact its investment potential.

Overview of Larotrectinib Sulfate

Larotrectinib targets tumors with NTRK gene fusions. It gained FDA approval in 2018 for patients aged over six months with TRK fusion-positive cancers. The indication covers various advanced solid tumors, including sarcomas, infantile fibrosarcomas, and neural tumors.

Market authorization: Approved in over 70 countries, including U.S., EU, Japan

Mechanism: Selectively inhibits TRKA, TRKB, TRKC proteins resulting from NTRK gene fusions

Clinical trials: Data from several pivotal trials show objective response rates (ORRs) of approximately 75% in TRK fusion-positive cancers with durable responses

Market Landscape and Competitive Position

Aspect	Larotrectinib	Competitor (Entrectinib)	Treatment Alternatives
Year of FDA approval	2018	2019	Chemotherapy, other targeted therapies
Spectrum of indication	TRK fusion-positive tumors across age groups	Same as Larotrectinib	Limited, non-specific to NTRK fusions
Key differentiation	High selectivity, favorable safety profile	Broader target profile, CNS activity	Varies, often less specific
Revenue (2022)	Estimated $200 million	Estimated $150 million	N/A

Larotrectinib's high response rates and safety profile position it favorably despite a limited patient population. Market penetration depends on diagnostic testing rates and reporting of NTRK fusions.

Clinical and Regulatory Trends

• Diagnostic integration: Fast adoption of NTRK fusion testing enhances market size.
• Expanding indications: Trials investigate larotrectinib in pediatric CNS tumors, potentially broadening the label.
• Regulatory developments: Continuous approvals, including in China (2019).

Financials and Investment Outlook

• Revenue growth: Rapid initial sales growth post-launch, with steady increase as diagnostic utilization expands.
• Cost considerations: Development costs mainly absorbed by the drug owner (e.g., Bayer). High R&D costs, but low production costs once established.
• Pricing strategy: List prices around $17,000 per month in the U.S. (per NICE guidelines), with broader pricing adjustments in other regions.
• Patent and exclusivity: Patent protection extends into the late 2020s; orphan drug designations prolong exclusivity.

Market Challenges and Risks

• Limited patient population: NTRK gene fusions occur in less than 1% of common cancers.
• Resistance development: Secondary mutations may reduce effectiveness, prompting need for next-generation inhibitors.
• Competitive landscape: Other targeted therapies and emerging agents could impact market share.
• Reimbursement: Payer policies on high-cost targeted treatments could limit access.

Strategic Considerations

• Partnerships: Collaborations with diagnostic firms can improve testing and patient matching.
• Pipeline expansion: Development of next-generation TRK inhibitors or combination regimes.
• Geography: Focus on regions with high diagnostic capability to expand revenue base.

Key Takeaways

• Larotrectinib sulfate demonstrates significant efficacy for TRK fusion-positive tumors with a favorable safety profile.
• Market growth depends on increasing diagnostic testing and expanding indications.
• Competitive advantages stem from high specificity and safety; market share remains limited by the rarity of NTRK gene fusions.
• Financial growth prospects hinge on regional approval, pricing, and reimbursement policies.
• Risks include resistance, small patient populations, and competitive dynamics.

FAQs

1. What makes larotrectinib sulfate a unique investment opportunity?
Its specificity for NTRK fusions and quick adoption in diagnostics provide predictable revenue streams within its niche.

2. How does larotrectinib compare with other targeted therapies?
It has a higher response rate and a more favorable safety profile but targets a rare mutation, limiting overall market size.

3. What are the key market drivers?
Increased NTRK fusion testing, expanded indications, and geographic market expansion drive revenue growth.

4. What are major risks to investing in larotrectinib?
Low prevalence of NTRK fusions, potential development of resistance, and reimbursement challenges pose risks.

5. How does regulatory status influence investment?
Regulatory approvals in multiple countries and orphan disease designation support market exclusivity and pricing power.

---

References

1. [1] U.S. Food and Drug Administration. (2018). FDA approves larotrectinib for solid tumors with NTRK gene fusion.
2. [2] European Medicines Agency. (2019). Vitrakvi approval details.
3. [3] National Comprehensive Cancer Network. (2022). NTRK fusion-positive tumors treatment guidelines.
4. [4] ClinicalTrials.gov. Larotrectinib clinical trial data overview.
5. [5] NICE. (2020). Evaluation of larotrectinib pricing and reimbursement.