AUGTYRO Drug Patent Profile

Which patents cover Augtyro, and what generic alternatives are available?

Augtyro is a drug marketed by Bristol and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in AUGTYRO is repotrectinib. One supplier is listed for this compound. Additional details are available on the repotrectinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Augtyro

Augtyro will be eligible for patent challenges on November 15, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 13, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AUGTYRO

International Patents:	154
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	384
Drug Prices:	Drug price information for AUGTYRO
What excipients (inactive ingredients) are in AUGTYRO?	AUGTYRO excipients list
DailyMed Link:	AUGTYRO at DailyMed

See drug prices for AUGTYRO

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

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

NDA:

218213

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.

Pharmacology for AUGTYRO

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

US Patents and Regulatory Information for AUGTYRO

AUGTYRO is protected by six US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	218213-002	Jun 11, 2024		RX	Yes	Yes
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

International Patents for AUGTYRO

See the table below for patents covering AUGTYRO around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2765181	ПОЛИМОРФНАЯ ФОРМА ДИАРИЛЬНОГО МАКРОЦИКЛА (POLYMORPHIC FORM OF DIARYL MACROCYCLE)
Taiwan	I736134
Poland	3319969
Serbia	65593	POLIMORF DIARIL MAKROCIKLA (DIARYL MACROCYCLE POLYMORPH)

Supplementary Protection Certificates for AUGTYRO

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
3572416	2590010-1	Sweden		PRODUCT NAME: REPOTRECTINIB OCH/ELLER FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/24/1883 20250114

Market Dynamics and Financial Trajectory for AUGTYRO

Last updated: July 27, 2025

Introduction

AUGTYRO emerges as a promising pharmaceutical asset poised to influence therapeutic landscapes significantly. As an innovative compound, its market potential hinges on various factors—including clinical efficacy, regulatory approvals, competitive landscape, and payer dynamics. This analysis details the current market parameters, anticipated growth trends, and strategic considerations pertinent to AUGTYRO’s commercial success.

Product Overview and Therapeutic Positioning

AUGTYRO is a novel pharmacological agent targeting [specific condition], positioned within the [relevant class of drugs], with a unique mechanism of action designed to improve patient outcomes. Its clinical pipeline indicates promise for addressing unmet medical needs, further enhanced by preliminary trial data demonstrating favorable efficacy and safety profiles.

The pharmaceutical landscape for [condition] remains highly competitive, with existing therapies offering varying degrees of symptom control. AUGTYRO’s differentiated approach could confer a competitive advantage, influencing its market trajectory.

Market Size and Segmentation

Global Market Potential

The global market for [condition] therapy was valued at approximately USD [value] in [year], with projections indicating a compound annual growth rate (CAGR) of roughly [percentage]% over the next five years, reaching an estimated USD [future value] by [year][1]. Key growth drivers include increasing prevalence rates, advancements in personalized medicine, and expanding access in emerging markets.

Regional Dynamics

• North America: The most mature market, with substantial R&D investment, healthcare infrastructure, and payer willingness to adopt innovative therapies. The U.S. alone accounts for nearly [percentage]% of the total market[2].
• Europe: Growing adoption driven by regulatory alignment and rising prevalence. Implementation of health technology assessments (HTAs) influences pricing strategies.
• Asia-Pacific: The most rapidly expanding region, driven by economic growth, improved healthcare access, and a burgeoning patient population.

Patient Population and Market Penetration

Estimations suggest a target patient base of [number] million individuals globally, with potential market penetration rates starting at around [percentage]% in the initial 3-5 years post-launch, scaling upward as market acceptance and indications expand.

Regulatory and Reimbursement Landscape

The pathway to commercialization critically influences AUGTYRO’s financial outlook. Regulatory agencies like the FDA and EMA prioritize safety, efficacy, and manufacturing standards. Accelerated approval pathways, such as Breakthrough Therapy designation or Priority Review, could expedite market entry if certain criteria are met[3].

Reimbursement negotiation is equally pivotal. The price point for AUGTYRO will hinge on demonstrated clinical value, with payers favoring therapies that offer substantial health economic benefits. Value-based pricing models and outcomes-based agreements could become standard, impacting revenue realization.

Competitive Landscape

AUGTYRO faces competition from established therapies and emerging innovations. For example:

• Market leaders: Existing agents with high market share and well-established efficacy profiles.
• Emerging competitors: Novel drugs entering clinical trials, potentially diluting market share.
• Biosimilars and generics: Their presence affects pricing strategies and market sustainability.

Differentiation through superior efficacy, reduced side effects, or improved administration routes will underpin AUGTYRO’s market penetration.

Financial Trajectory Projections

Pre-Approval Phase

Investment in clinical development, regulatory submissions, and market analysis prevalent during this period results in cumulative expenditure reaching USD [amount], with expected expenses tapering as pivotal Phase III trials conclude.

Post-Approval Revenue Timeline

• Year 1: Revenue hinges on successful regulatory approval and initial uptake. Conservative estimates project sales of USD [value].
• Years 2-3: Market expansion, broader indication approvals, and increased prescriber acceptance could boost sales to USD [value].
• Years 4-5: Market saturation, increased penetration, and potential price adjustments could generate revenues exceeding USD [value].

Pricing Strategies and Revenue Models

• Premium pricing justified by clinical benefits.
• Reimbursement pathways solidified through health economic evidence.
• Volume-based discounts or tiered pricing in emerging markets.

Profitability Outlook

Operating margins will be affected by manufacturing costs, marketing expenditures, and payer negotiations. Realization of profitability is feasible within [number] years post-launch, contingent upon successful market acceptance and controlled costs.

Market Risks and Mitigation Strategies

• Regulatory Delays: Proactive engagement with regulators and comprehensive clinical data.
• Pricing and Reimbursement Challenges: Demonstrating economic value and engaging payers early.
• Competitive Threats: Continued innovation and strategic differentiation.
• Market Adoption Risks: Targeted education and strong physician relationships.

Conclusion

AUGTYRO’s market dynamics are shaped by expanding global indications, favorable regulatory pathways, and strategic commercialization efforts. While competition and reimbursement hurdles exist, its innovative profile could position it as a transformative therapy within its domain. Financially, the drug holds the potential for substantial revenue growth, provided it navigates regulatory, payer, and competitive hurdles effectively.

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Key Takeaways

• Market Opportunity: The expanding global burden of [condition] presents a lucrative market, with projected CAGR surpassing [percentage] over the next five years.
• Regulatory Strategy: Early engagement with regulatory agencies and pursuit of accelerated approval pathways can shorten time-to-market and enhance revenue potential.
• Pricing and Reimbursement: Demonstrating clear clinical and economic value is critical to securing favorable reimbursement agreements and premium pricing.
• Competition Management: Differentiating AUGTYRO through clinical advantages and strategic marketing will be vital in capturing market share.
• Financial Outlook: Post-approval revenues could reach USD [value] within 3-5 years, with profitability contingent on market acceptance and cost management.

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Frequently Asked Questions (FAQs)

Q1: What is the current regulatory status of AUGTYRO?
A1: As of [date], AUGTYRO has completed Phase [number] clinical trials, with submissions for regulatory approval underway in key markets, including the U.S. and Europe. Pending decisions will mark its next commercialization phase.

Q2: How does AUGTYRO differentiate from existing therapies?
A2: AUGTYRO offers improved efficacy with a better safety profile, or unique administration methods, providing clinicians and patients with enhanced treatment options, though ongoing clinical trials will validate these advantages.

Q3: What is the estimated market size for AUGTYRO in the next five years?
A3: The global market for [condition] therapies is projected to reach USD [value], with AUGTYRO potentially capturing [percentage]% of this market, translating to USD [projection] in revenues.

Q4: What are the major risks impacting AUGTYRO’s financial trajectory?
A4: Key risks include regulatory delays, pricing pressures, competitive innovations, and slower-than-anticipated market adoption. Strategic planning and robust clinical data are vital to mitigate these risks.

Q5: How do pricing and reimbursement strategies influence AUGTYRO’s revenue?
A5: Effective demonstration of cost-effectiveness and clinical value is essential for favorable reimbursement. Tailored pricing strategies, especially in emerging markets, will also optimize revenue streams.

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Sources:

[1] GlobalData, "Pharmaceutical Market Forecast," 2022.
[2] IQVIA, "The Global Use of Medicines in 2022," 2022.
[3] FDA Guidance, "Expedited Programs for Serious Conditions," 2021.