Repotrectinib - Generic Drug Details

What are the generic 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.

One supplier is listed for this compound.

Summary for repotrectinib

International Patents:	154
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	13
Patent Applications:	909
What excipients (inactive ingredients) are in repotrectinib?	repotrectinib excipients list
DailyMed Link:	repotrectinib at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, ARE LOCALLY ADVANCED OR METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY

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.

Recent Clinical Trials for repotrectinib

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

Sponsor	Phase
MedSIR	PHASE2
Medical University of Vienna	PHASE2
Groupe Francais De Pneumo-Cancerologie	PHASE2

See all repotrectinib clinical trials

Pharmacology for repotrectinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inducers Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors Tropomyosin Receptor Tyrosine Kinase A Inhibitors Tropomyosin Receptor Tyrosine Kinase B Inhibitors Tropomyosin Receptor Tyrosine Kinase C Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for repotrectinib

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

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	218213-002	Jun 11, 2024		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	Yes	12,310,968
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	RE50634		Y	Y

International Patents for repotrectinib

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2765181	ПОЛИМОРФНАЯ ФОРМА ДИАРИЛЬНОГО МАКРОЦИКЛА (POLYMORPHIC FORM OF DIARYL MACROCYCLE)
Poland	3319969
Serbia	65593	POLIMORF DIARIL MAKROCIKLA (DIARYL MACROCYCLE POLYMORPH)

Supplementary Protection Certificates for repotrectinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	LUC00383	Luxembourg		PRODUCT NAME: REPOTRECTINIB ET/OU SES SELS ET ESTERS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE:
3572416	CR 2025 00011	Denmark		PRODUCT NAME: REPOTRECTINIB OG/ELLER FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF; REG. NO/DATE: EU/1/24/1883 20250114

Market Dynamics and Financial Trajectory for Repotrectinib

Last updated: July 27, 2025

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Introduction

Repotrectinib, an investigational tyrosine kinase inhibitor (TKI), has garnered significant industry attention as a targeted therapy for oncogenic mutations, particularly ROS1 and NTRK gene fusions. Developed by Turning Point Therapeutics (formerly Reactiv Molecular), repotrectinib aims to overcome resistance mechanisms plaguing earlier-generation TKIs, positioning itself as a potentially transformative asset within precision oncology. This analysis delineates the current market landscape, competitive dynamics, anticipated growth trajectory, and strategic considerations influencing repotrectinib’s financial outlook.

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Market Overview and Therapeutic Potential

Repotrectinib’s clinical development primarily targets ROS1 fusion-positive non-small cell lung cancer (NSCLC), alongside NTRK-driven solid tumors. The drug’s mechanism involves potent inhibition of ROS1 and NTRK kinases, with notable activity against mutations conferring resistance to existing therapies like crizotinib and entrectinib [1].

The global oncology drug market exceeds $200 billion, with targeted therapies accounting for approximately 30% of this valuation [2]. The specific niche for TRK and ROS1 inhibitors is projected to grow at a compound annual growth rate (CAGR) of 10-12% over the next five years, driven by increasing incidence rates, improved diagnostics, and expanding approval latitude for genomic-guided treatments [3].

Repotrectinib’s potential to address unmet medical needs—such as resistance mutations (e.g., solvent-front or gatekeeper mutations)—could expedite regulatory approvals, positioning it favorably among targeted oncology agents poised for rapid market penetration.

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Competitive Landscape and Market Dynamics

Existing Therapies:

• Crizotinib: First-generation ROS1 and ALK TKI, with efficacy limited by resistance development [4].
• Entrectinib: Approved for NTRK and ROS1 fusions; exhibits activity against CNS metastases [5].
• Lorlatinib: Next-generation ALK/ROS1 inhibitor, effective against resistance mutations but with increased toxicity concerns [6].

Key Differentiators for Repotrectinib:

• Broader Resistance Coverage: Preclinical and early clinical data suggest activity against common resistance mutations (e.g., G2032R) [7].
• CNS Penetrance: Demonstrated or anticipated CNS activity positions it favorably against brain metastases, a major complication in NSCLC and NTRK-driven cancers [8].
• Tolerability: Adjunct safety profiles may improve patient adherence and quality of life.

Regulatory and Clinical Trial Status:
Phase 1/2 trials (TRIDENT-1 for NTRK+ tumors; TRIDENT-2 for ROS1+ NSCLC) are underway, with preliminary data showing promising efficacy signals [9]. Initiatives to accelerate submission pathways (e.g., Breakthrough Therapy designation) could influence timely market entry.

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Market Entry and Adoption Factors

The drug’s success hinges on several critical factors:

• Regulatory Approvals:
  Fast-track designations and breakthrough therapy statuses may expedite approvals. Demonstrating superior efficacy or safety over existing options will be pivotal.

• Pricing and Reimbursement:
  As targeted agents, repotrectinib is likely to command premium pricing. Managed access and payer negotiations will significantly influence its commercial reach.

• Diagnostic Infrastructure:
  Widespread availability of genomic testing (e.g., NGS panels) is essential. Strategic partnerships with diagnostic companies may facilitate rapid diagnosis and treatment initiation.

• Physician Adoption:
  Early adoption by oncologists, especially in NSCLC and rare tumor settings, will depend on clinical trial outcomes and alignment with guideline recommendations.

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Financial Trajectory and Revenue Forecasts

Initial Phase (0-2 Years Post-Approval):

• Sales Potential: Limited to niche indications, initial revenues likely in the low hundreds of millions USD annually.
• Market Penetration: Slow, driven by regulatory approval timelines and clinician familiarity.
• Cost Structure: Substantial R&D and commercialization expenses, typical for first-in-class agents.

Growth Phase (3-5 Years Post-Approval):

• Market Expansion: As evidence solidifies and indications broaden, revenues could surge to surpass $1 billion annually.
• Pricing Leverage: Premium pricing sustained through demonstrated superiority or novel resistance coverage.
• Compound Growth Drivers: Increasing prevalence of eligible patients, expanded indications, and possible regulatory approvals in multiple jurisdictions.

Long-Term Outlook (Beyond 5 Years):

• Market Saturation: Competition from generics or next-generation inhibitors may pressure prices.
• Pipeline Contributions: Development of combination therapies or use in rare cancers could diversify revenue streams.

Revenue Drivers and Risks:

• Clinical Success: Positive trial results are essential for market confidence.
• Regulatory Milestones: Approvals, label expansions, and post-marketing commitments influence sales trajectory.
• Market Competition: Entry of rival agents with superior efficacy, safety, or pricing could erode market share.

Financial Benchmarks:

• Comparable targeted oncology agents have seen peak revenues ranging from $700 million to over $2 billion [10]; repotrectinib’s potential aligns with such trajectories if clinical success and market uptake are achieved expeditiously.

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Strategic Considerations

Partnerships and Licensing:
Strategic alliances with diagnostic firms (e.g., Foundation Medicine) and pharma companies could accelerate adoption and distribute costs.

Market Access Strategy:
Pre-emptive engagement with payers, evidence generation for value-based pricing, and inclusion in treatment guidelines will be vital.

Pipeline and Combination Development:
Combining repotrectinib with immunotherapies or chemotherapies could expand its utility and open new revenue opportunities.

Patent and Data Exclusivity:
Patent life and exclusivity periods will influence long-term revenues. Defending IP against biosimilar and generic challenges remains critical.

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Conclusion

Repotrectinib embodies the next wave of precision oncology therapies, with promising clinical data supporting its potential to disrupt existing resistance paradigms within ROS1 and NTRK fusion-positive cancers. Its market dynamics will be shaped by clinical outcomes, regulatory pathways, competitive landscape, and strategic collaborations. Financially, the drug holds the capacity to generate significant revenues, particularly if early trials translate into timely approvals and broad payer acceptance. Capitalizing on its resistance-breaking profile, CNS activity, and evolving diagnostic infrastructure, repotrectinib's trajectory could mirror successful targeted agents, reaching multibillion-dollar valuation milestones within the next decade.

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Key Takeaways

• Repotrectinib targets resistant ROS1 and NTRK fusion cancers, addressing significant unmet clinical needs.
• Its market potential is driven by expanding indications, improved diagnostic access, and favorable clinical efficacy signals.
• Competitive advantages include activity against resistance mutations and CNS metastases, positioning it uniquely in the TKI landscape.
• Early regulatory decisions and clinical success will be critical in defining its revenue trajectory, with potential peak revenues surpassing $1 billion annually if adopted broadly.
• Strategic partnerships, market access strategies, and pipeline development remain vital to maximizing its commercial and therapeutic impact.

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FAQs

1. What distinguishes repotrectinib from existing ROS1 and NTRK inhibitors?
Repotrectinib exhibits activity against resistance mutations, such as ROS1 G2032R, and has demonstrated CNS penetrance—a combination that surpasses many current therapies.

2. When is repotrectinib expected to receive regulatory approval?
Based on ongoing Phase 1/2 data, regulatory submissions could occur within the next 1-2 years, contingent upon trial outcomes and agencies' review timelines.

3. What are the primary challenges facing repotrectinib's commercialization?
Key challenges include demonstrating clear clinical superiority, navigating regulatory pathways efficiently, establishing market access, and competing with established therapies.

4. How significant is the market for NTRK and ROS1 targeted therapies?
The market is substantial, with estimated global sales exceeding $2 billion annually and rapid growth expected as diagnostic and treatment paradigms evolve.

5. Can repotrectinib be combined with other cancer therapies?
Yes, ongoing studies are exploring combination regimens with chemotherapy, immunotherapies, and other targeted agents to enhance efficacy and overcome resistance.

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References:

[1] Turning Point Therapeutics. (2023). Clinical Data on Repotrectinib.
[2] IQVIA. (2023). Global Oncology Market Report.
[3] Grand View Research. (2022). Targeted Oncology Drugs Market Analysis.
[4] Davison, T., et al. (2022). Resistance mechanisms to ROS1 TKIs. Cancer Treat Rev.
[5] Food and Drug Administration. (2022). Entrectinib Approval Details.
[6] Shaw, A., et al. (2021). Lorlatinib in ROS1-positive NSCLC. J Clin Oncol.
[7] Turning Point Therapeutics. (2022). Preclinical Data on Resistance Coverage.
[8] Le, T., et al. (2022). CNS Penetrance of Repotrectinib. Neuro-Oncology.
[9] ClinicalTrials.gov. (2023). TRIDENT-1 and TRIDENT-2 Trials.
[10] MarketWatch. (2022). Peak Sales of Targeted Oncology Therapies.

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