Repotrectinib - Generic Drug Details

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

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:	14
Patent Applications:	909
What excipients (inactive ingredients) are in repotrectinib?	repotrectinib excipients list
DailyMed Link:	repotrectinib at DailyMed

Recent Clinical Trials for repotrectinib

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

Sponsor	Phase
MedSIR	PHASE2
Medical University of Vienna	PHASE2
Hospices Civils de Lyon	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	218213-001	Nov 15, 2023		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes			Y	Y
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	Yes			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
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	Yes				Y

International Patents for repotrectinib

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3636648	MACROCYCLES DE DIARYLE EN TANT QUE MODULATEURS DE PROTÉINES KINASES (DIARYL MACROCYCLES AS MODULATORS OF PROTEIN KINASES)
European Patent Office	4480543	MACROCYCLE DIARYLE CHIRAL ET SON UTILISATION DANS LE TRAITEMENT DU CANCER (CHIRAL DIARYL MACROCYCLE AND USE THEREOF IN THE TREATMENT OF CANCER)
Croatia	P20240780
Taiwan	I736134
South Korea	102623734
Denmark	3097107

Supplementary Protection Certificates for repotrectinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	LUC00383	Luxembourg		PRODUCT NAME: REPOTRECTINIB ET/OU SES SELS ET ESTERS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE:
3572416	122025000017	Germany		PRODUCT NAME: REPOTRECTINIB UND/ODER PHARMAZEUTISCH ANNEHMBARE SALZE UND ESTER DAVON; REGISTRATION NO/DATE: EU/1/24/1883 20250113
3572416	C20250015	Finland		PRODUCT NAME: IMETELSTAAT;REG NO/DATE: EU/1/24/1894 11.03.2025
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	2590010-1	Sweden		PRODUCT NAME: REPOTRECTINIB OCH/ELLER FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/24/1883 20250114

Last updated: February 12, 2026

What is the current market landscape for REPOTRECTINIB?

Repotrectinib, a tyrosine kinase inhibitor developed by Turning Point Therapeutics, enters a competitive market focused on targeted cancer therapies. Its primary indications target ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors with specific genetic alterations.

The drug benefits from a growing unmet need for treatments overcoming resistance to existing therapies like crizotinib and entrectinib. Global NSCLC market size was valued at approximately $17 billion in 2022, with targeted therapies segment expanding at a compound annual growth rate (CAGR) of 12%. Repotrectinib's niche addresses patients with specific resistance mutations, giving it potential to capture significant clinical traction.

Major competitors include established drugs such as crizotinib, entrectinib, and newer agents like lorlatinib and other TRK inhibitors. These drugs dominate the market via expanded indications and improved efficacy.

How is the developmental and regulatory pipeline affecting repotrectinib's market potential?

Turning Point filed an Investigational New Drug (IND) application for repotrectinib in 2018. It has completed Phase 1 trials, demonstrating encouraging safety and efficacy data. The Phase 2 TRIDENT-1 trial focuses on ROS1-positive NSCLC patients with resistance mutations.

In March 2023, Roche’s entrectinib received FDA approval for TRK fusion-positive solid tumors, increasing competition. Repotrectinib’s regulatory path includes filing for accelerated approval based on early data, projected for 2024.

Studies show repotrectinib may overcome resistance to first-line ROS1 therapies, positioning it as a potential second-line agent. The timeline for regulatory approval remains uncertain, with potential for FDA breakthrough therapy designation based on early efficacy signals.

What are the financial projections and market adoption prospects for repotrectinib?

Pricing models for novel targeted therapies tend to range from $15,000 to $20,000 monthly per patient. Assuming a launch in the US and EU, annual peak revenue estimates for repotrectinib span $500 million to $2 billion, contingent on approval speed, market penetration, and competition.

Initial market penetration is expected to be modest in the first 1-2 years post-approval, primarily targeting patients with resistance mutations in ROS1-positive NSCLC. Adoption depends on data demonstrating superior efficacy and safety relative to existing therapies.

Revenue growth forecasts assume rapid expansion in clinical indications, including other ROS1-positive tumors and TRK fusion-positive cancers. Long-term revenue could be constrained if competitors accelerate approval or if resistance mechanisms diminish drug utility.

What are the key risks influencing the financial outlook?

• Regulatory delays or rejection: FDA or EMA decisions could postpone the drug’s launch or restrict indications.
• Competitive landscape: Introduction of superior therapies may limit market share. Roche's entrectinib and others could gain approvals for broader indications.
• Clinical data performance: Phase 2 and 3 trials must demonstrate clear efficacy and safety. Negative results could impair investment returns.
• Pricing and reimbursement: Payers may impose restrictions or limit coverage, affecting margins.

What strategic considerations should investors and stakeholders monitor?

• Timing and outcomes of regulatory submissions
• Development of biomarker tests for patient stratification
• Expansion of indication beyond NSCLC to broader tumor types
• Partnerships or licensing agreements with larger pharma entities
• Competition dynamics, including potential patent challenges and generic entries

Key Takeaways

• Repotrectinib targets resistant ROS1-positive NSCLC and has potential in broader tumor types.
• It faces competition from existing therapies with established market presence.
• Regulatory approval timing remains uncertain, with early data supporting accelerated pathways.
• Financial projections predict peak revenues of $500 million to $2 billion, dependent on market penetration and indication expansion.
• Risks include regulatory hurdles, competitive threats, and clinical trial outcomes.

FAQs

What diseases does repotrectinib treat?
Primarily ROS1-positive NSCLC with resistance mutations; potential for other solid tumors with specific genetic alterations.

When is the expected FDA approval?
Pending submission of pivotal data, likely in 2024, with accelerated approval prospects based on early Phase 2 results.

What is the competitive advantage of repotrectinib?
Potential to overcome resistance mutations that limit existing ROS1 inhibitors.

How does pricing impact revenue projections?
Targeted therapies are priced around $15,000-$20,000/month; market uptake hinges on negotiated reimbursement and patient access.

What are the main challenges to market entry?
Regulatory delays, competition, clinical trial results, and payer coverage policies.

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References

1. MarketWatch. "Global Non-Small Cell Lung Cancer Market Size, 2023," accessed March 2023.
2. Turning Point Therapeutics. "Repotrectinib Development Program," company reports, 2022.
3. FDA. "Approved Drugs for TRK Fusion-Positive Cancers," 2022.
4. Pharma Intelligence. "Targeted Cancer Therapy Market Analysis," March 2023.
5. Seeking Alpha. "Repotrectinib Revenue Outlook," Analysts Reports, 2023.