repotrectinib - Profile

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

Repotrectinib is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Repotrectinib has one hundred and fifty-four patent family members in thirty-eight countries.

Summary for repotrectinib

International Patents:	154
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1

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

Constraining patent/regulatory exclusivity:

10,294,242

Dosage:

CAPSULE;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.

US Patents and Regulatory Information for repotrectinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	12,310,968
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	11,452,725
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	RE50634		Y	Y
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	10,294,242			Y
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	12,187,739		Y
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes

International Patents for repotrectinib

Country	Patent Number	Title	Estimated Expiration
Australia	2016289454
Brazil	112018000297
Canada	2990020
China	108026108
China	113354653
Denmark	3319969
European Patent Office	3319969

Supplementary Protection Certificates for repotrectinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3572416	CR 2025 00011	Denmark		PRODUCT NAME: REPOTRECTINIB OG/ELLER FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF; REG. NO/DATE: EU/1/24/1883 20250114
3572416	CA 2025 00011	Denmark		PRODUCT NAME: REPOTRECTINIB OG/ELLER FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF; REG. NO/DATE: EU/1/24/1883 20250114
3572416	301322	Netherlands		PRODUCT NAME: REPOTRECTINIB EN/OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/24/1883 20250114
3572416	122025000017	Germany		PRODUCT NAME: REPOTRECTINIB UND/ODER PHARMAZEUTISCH ANNEHMBARE SALZE UND ESTER DAVON; REGISTRATION NO/DATE: EU/1/24/1883 20250113
3572416	2025C/513	Belgium		PRODUCT NAME: REPOTRECTINIB EN/OF FARMACEUTISCH AANVAARDBARE ZOUTEN EN ESTERS DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/24/1883 20250114
3572416	PA2025513	Lithuania		PRODUCT NAME: REPOTREKTINIBAS IR (ARBA) JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IRESTERIAI; REGISTRATION NO/DATE: EU/1/24/1883/001-004 20250113
3572416	LUC00383	Luxembourg		PRODUCT NAME: REPOTRECTINIB ET/OU SES SELS ET ESTERS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE:

Repotrectinib: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Repotrectinib (D-0001) is a next-generation, small-molecule tyrosine kinase inhibitor (TKI), targeting ROS1, NTRK, and ALK gene rearrangements in cancers. Developed by Turning Point Therapeutics, it addresses resistance mechanisms associated with earlier-generation TKIs, positioning it as a promising candidate in the targeted oncology market. This report analyzes the drug's investment landscape, market dynamics, and projected financial trends, integrating current clinical data, competitive positioning, regulatory outlook, and market potential.

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What Is Repotrectinib and Its Therapeutic Indications?

Attribute	Details
Therapeutic Area	Oncology (Targeted therapy for specific genetic mutations)
Primary Targets	ROS1, NTRK, ALK rearrangements
Indications	Non-small cell lung cancer (NSCLC), other solid tumors
Development Stage	Phase 2/Registration-ready (as of 2023)
Mechanism	Multi-kinase inhibition overcoming resistance to first-generation TKIs

Source: Turning Point Therapeutics [1]

Market Landscape and Competitive Environment

Market Size and Growth Potential

Market Segment	Market Size (USD billion)	CAGR (2022-2027)	Key Drivers
ROS1-positive NSCLC	~$2.5	12%	Increased genetic testing, targeted therapy adoption
NTRK fusion-positive solid tumors	~$1.2	15%	Rare tumor diagnosis, expanding genetic testing
ALK-positive NSCLC	~$4.0	11%	Continued approval of TKIs, resistance management

Note: Markets based on Global Data Point estimates [2]

Competitive Positioning

Competitor	Approximate Market Share	Key Drugs	Differentiators
Entrectinib (Rozlytrek)	Leading	Entrectinib (Pfizer)	Approved for NTRK, ROS1; CNS activity
Larotrectinib (Vitrakvi)	High	Larotrectinib (Loxo/AbbVie)	Approved for NTRK fusions regardless of tumor type
Crizotinib (Xalkori)	Mature	Crizotinib	Early ROS1/ALK inhibitor, resistance challenges
Repotrectinib	Emerging	Repotrectinib (Turning Point)	Next-generation, overcoming resistance, broader spectrum

Sources: FDA approvals, clinical trial data [3], company filings

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Clinical and Regulatory Milestones

Year	Milestone	Impact
2019	Initiation of clinical trials	Validation of safety signals
2021	Phase 1/2 data release showing intracranial activity and overcoming resistance	Strengthened R&D valuation
2022	IND acceptance by FDA	Regulatory progress and potential commercialization
2023	Ongoing Phase 2 trials targeting TKI-resistant NSCLC	Positioning for registration

Source: Turning Point press releases [4]

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Investment Scenario Analysis

Financial Projections and Revenue Modeling

Assumptions	Values and Bases
Market penetration (Year 5)	10–15% in ROS1/NTRK/ALK subsets
Pricing	USD 12,000 – 15,000 per month (estimated)
Duration of therapy	12–24 months, depending on indication
Licensing & partnerships	Potential in-licensing agreements with big pharma

Year	Estimated Revenue (USD millions)	Notes
2023	<$50	Early trial data, no commercialization
2024	$100–$250	Clinical data highlights, early partnerships
2025	$500–$1,200	Phase 2 data, potential regulatory filing
2026	$1,800–$3,000	Launch in select territories, expanding indications
2027	$4,000–$6,000	Market penetration, label expansion

Note: These are conservative estimates considering late-stage approval timing, competitive dynamics, and pricing negotiations.

Investment Risks and Considerations

Risk Factor	Description
Clinical efficacy and safety	Potential adverse outcomes or lack of superiority
Regulatory hurdles	Delays or rejection due to safety concerns
Competitive landscape	Entrenched market leaders and upcoming alternatives
Market adoption	Physician acceptance of new differentiation
Pricing and reimbursement	Negotiation challenges impacting margins

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Market Dynamics and Commercial Strategy

Key Drivers Facilitating Market Penetration

• Increasing molecular testing rates allow identification of eligible patients.
• Growing acceptance of targeted therapies in oncology protocols.
• Development of resistance-resistant next-generation TKIs like repotrectinib.
• Broader indications beyond NSCLC, including salivary gland tumors and pediatric cancers.

Barriers to Entry

• Established competitors with FDA-approved drugs.
• Necessity of demonstrating clear clinical benefit over existing options.
• Complex and costly regulatory approval pathways.
• Reimbursement hurdles, especially in price-sensitive markets.

Strategic Partnerships and Licensing Opportunities

• Collaboration with pharmaceutical giants for commercialization.
• Licensing dual or global territories for accelerated market access.
• Investment in combination therapy trials to expand indications.

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Financial Trajectory: Comparing Repotrectinib with Competitors

Aspect	Repotrectinib	Entrectinib	Larotrectinib
Approval Status	Phase 2/Registration	Approved	Approved
Indications	NTRK, ROS1, ALK	NTRK, ROS1	NTRK
Patents	Filed/Granted	Granted	Granted
Market Penetration	Early stage	Mature	Mature

Implication: Repotrectinib's potential for rapid growth hinges on successful phase 2/3 trials and strategic partnerships, which could position it as a disruptor in the kinase inhibitor market.

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Regulatory Landscape and Policy Environment

Regulatory Authority	Status	Notable Considerations
FDA (U.S.)	Pending/IND	Fast Track, Priority Review possible
EMA (Europe)	Not yet	Awaiting trial data
Japan PMDA	Not yet	Consideration for approvals in Asian markets

Key Policy Trends

• Emphasis on biomarker-driven approvals.
• Expansion of companion diagnostics.
• Policies promoting orphan drug designations for rare cancers with NTRK fusion.

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Comparison of Repotrectinib with Other Targeted Oncology Drugs

Characteristic	Repotrectinib	Entrectinib	Larotrectinib	Crizotinib	Alectinib
Target Spectrum	ROS1, NTRK, ALK	NTRK, ROS1	NTRK	ROS1, ALK	ALK
Resistance Profile	Designed to overcome	Limited	Limited	Resistance issues	Resistance issues
CNS Activity	Promising	Confirmed	Confirmed	Confirmed	Confirmed
Development Stage	Phase 2	Approved	Approved	Approved	Approved

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Key Takeaways

• Repotrectinib is positioned as a next-generation kinase inhibitor with potential to penetrate resistance barriers in targeted oncology therapies.
• The drug’s success depends on demonstrating superior efficacy, safety, and tolerability compared to existing options, notably Entrectinib and Larotrectinib.
• Market growth is driven by increased molecular diagnostics, expanding indications, and broader acceptance of targeted therapies.
• Strategic partnerships and licensing deals are critical to accelerate market entry and maximizing commercial potential.
• Risks include clinical failure, regulatory delays, competitive responses, and reimbursement challenges.

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FAQs

Q1: What differentiates repotrectinib from earlier-generation ALK or ROS1 inhibitors?
A1: Repotrectinib has been engineered for improved CNS penetration and activity against resistance mutations that compromise earlier inhibitors like crizotinib. Its compact structure allows for better receptor affinity and blood-brain barrier crossing.

Q2: When is repotrectinib expected to receive regulatory approval?
A2: Based on current development timelines and trial data readouts, regulatory filings may occur in 2024 or 2025, with approval potentially granted within a year after submission, contingent on trial outcomes.

Q3: How does the competitive landscape impact repotrectinib's commercialization?
A3: Established drugs like Entrectinib and Larotrectinib already hold market share, particularly for NTRK-fusion tumors. Repotrectinib's ability to demonstrate superior efficacy against resistant tumors and expand indications will determine its market share.

Q4: What are the primary indications for repotrectinib?
A4: The primary indications include ROS1-positive non-small cell lung cancer, NTRK fusion-positive solid tumors, and ALK-rearranged cancers, especially in resistant cases.

Q5: What strategies can maximize repotrectinib's commercial success?
A5: Strategies include rapid registration through fast-track designations, forming strategic partnerships with major pharma companies, expanding indications via clinical trials, and deploying targeted marketing in key markets.

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References

[1] Turning Point Therapeutics. “Repotrectinib (D-0001).” 2023.

[2] Global Data Point. “Targeted Oncology Market Reports,” 2022.

[3] FDA & EMA Clinical Trial Data. “Kinase Inhibitor Approvals,” 2023.

[4] Turning Point Therapeutics. “Press Releases and Updates,” 2019–2023.