ROZLYTREK Drug Patent Profile

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

Rozlytrek is a drug marketed by Genentech Inc and is included in two NDAs. There are fourteen patents protecting this drug.

This drug has one hundred and twenty-nine patent family members in thirty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Rozlytrek

Rozlytrek was eligible for patent challenges on August 15, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 20, 2030. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ROZLYTREK

International Patents:	129
US Patents:	14
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	9
Patent Applications:	1,735
Drug Prices:	Drug price information for ROZLYTREK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ROZLYTREK
What excipients (inactive ingredients) are in ROZLYTREK?	ROZLYTREK excipients list
DailyMed Link:	ROZLYTREK at DailyMed

See drug prices for ROZLYTREK

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

Constraining patent/regulatory exclusivity:

10,398,693

NDA:

212725

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF PEDIATRIC PATIENTS OLDER THAN 1 MONTH UP TO 12 YEARS OF AGE WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY

NDA:

218550

Dosage:

PELLETS;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 ROZLYTREK

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

Sponsor	Phase
University of Manchester	Phase 2/Phase 3
Hoffmann-La Roche	Phase 2/Phase 3
University of Birmingham	Phase 2/Phase 3

See all ROZLYTREK clinical trials

US Patents and Regulatory Information for ROZLYTREK

ROZLYTREK is protected by nineteen US patents and six FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF PEDIATRIC PATIENTS OLDER THAN 1 MONTH UP TO 12 YEARS OF AGE WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE 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
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes	10,398,693		Y
Genentech Inc	ROZLYTREK	entrectinib	PELLETS;ORAL	218550-001	Oct 20, 2023		RX	Yes	Yes
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes	8,673,893
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes	10,561,651
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No	9,616,059

EU/EMA Drug Approvals for ROZLYTREK

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Rozlytrek	entrectinib	EMEA/H/C/004936Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior NTRK inhibitorwho have no satisfactory treatment options.Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.	Authorised	no	no	no	2020-07-31

International Patents for ROZLYTREK

When does loss-of-exclusivity occur for ROZLYTREK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

South Korea

Taiwan

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

See the table below for additional patents covering ROZLYTREK around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018201037
Japan	2020527575	エントレクチニブを含む薬学的組成物
Japan	2021042213
Australia	2013265288
Taiwan	201400479	Process for the preparation of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide

Supplementary Protection Certificates for ROZLYTREK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2176231	2020C/551	Belgium		PRODUCT NAME: ENTRECTINIB OF ISOMEREN, TAUTOMEREN OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803
3107541	SPC/GB21/034	United Kingdom		PRODUCT NAME: ENTRECTINIB, AND ISOMERS, TAUTOMERS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/20/1460 (NI) 20200803; UK PLGB00031/0913 20200803; UK PLGB00031/0914 20200803
2176231	132020000000164	Italy		PRODUCT NAME: ENTRECTINIB O SUOI ISOMERI, TAUTOMERI O SALI FARMACEUTICAMENTE ACCETTABILI(ROZLYTREK); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1460, 20200803
2176231	CA 2020 00058	Denmark		PRODUCT NAME: ENTRECTINIB ELLER ISOMERER, TAUTOMERER ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/20/1460 20200803
2176231	LUC00191	Luxembourg		PRODUCT NAME: ENTRECTINIB OU LES ISOMERES, TAUTOMERES, OU SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803

Market Dynamics and Financial Trajectory for Rozlytrek (Entrectinib)

Last updated: July 27, 2025

Introduction

Rozlytrek (entrectinib) is an oral, selective tyrosine kinase inhibitor developed by Genentech/Roche for treating specific tumors, including neurotrophic receptor tyrosine kinase (NTRK) gene fusion-positive cancers and ROS1-positive non-small cell lung cancer (NSCLC). Since its regulatory approval, Rozlytrek has experienced dynamic market reception driven by expanding indications, competitive landscape shifts, and evolving reimbursement policies. This analysis elucidates the key market forces shaping Rozlytrek’s commercial trajectory and provides a financial outlook grounded in current data.

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Market Overview

Therapeutic Indications and Unmet Needs

Rozlytrek received FDA approval in August 2019 for adult and pediatric patients with metastatic NTRK fusion-positive solid tumors, representing a significant milestone in precision oncology. Subsequently, in 2020, the FDA extended approval for ROS1-positive NSCLC, broadening its clinical applications.

The prevalence of NTRK gene fusions in solid tumors is rare, estimated at approximately 0.1–1% across various cancers, but the high potency of targeted therapies like Rozlytrek has transformed treatment paradigms for these patients. Similarly, ROS1 rearrangements occur in roughly 1–2% of NSCLC cases. These targeted subpopulations, though small, are underserved, creating a niche market characterized by high unmet needs.

Market Size and Growth Drivers

The global oncology drug market surpasses $200 billion, with targeted therapies forming a significant segment. The niche targeting NTRK and ROS1 alterations is comparatively modest but influential, especially as diagnostics improve. By 2025, the NTRK inhibitor market is projected to grow at a CAGR of 20%, driven by increased biomarker testing and expansion into expanded age groups, including pediatric populations.

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Market Dynamics

Competitive Landscape

Rozlytrek faces competition from other NTRK inhibitors like Larotrectinib (Vitrakvi, BioNTech) and now emerging agents such as entrectinib’s generics. Larotrectinib was approved earlier in 2018, claiming a first-mover advantage with substantial clinical data supporting its efficacy across multiple tumor types. However, Rozlytrek's dual activity against ROS1 provides a competitive edge in NSCLC, where it is often part of combination or sequential therapies.

Furthermore, the increasing availability of comprehensive molecular diagnostics (e.g., NGS panels) facilitates patient identification, thus augmenting drug uptake. The growth of genomic testing labs is vital to expanding market penetration for drugs like Rozlytrek.

Pricing and Reimbursement Trends

Rozlytrek is positioned as a premium-priced agent, with annual costs estimated at over $200,000 per patient, aligning with other targeted therapies. Payers have shown mixed responses—some restrict access through prior authorization, while others recognize the clinical value.

Reimbursement policies are evolving, with payers favoring biomarker-driven treatment algorithms. Coverage decisions often depend on diagnostic testing reimbursement, emphasizing the importance of companion diagnostic co-development.

Regulatory and Approval Landscape

In addition to the US, Rozlytrek is approved in Europe, Japan, and Canada. Ongoing efforts aim to expand indications, particularly in pediatric populations and additional tumor types, which could propel market growth.

Disease-specific orphan drug designations and accelerated approvals have facilitated faster market entry, though sustained commercial success requires demonstrating long-term benefits and real-world effectiveness.

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Financial Trajectory

Sales Performance and Forecast

Initial sales of Rozlytrek have been promising, with Roche reporting global sales exceeding CHF 300 million in 2021. The trajectory is expected to accelerate as indications expand and diagnostic testing uptake increases. Key factors influencing revenue include:

• Market Penetration: Early adoption driven by specialist oncologists.
• Diagnostic Integration: Increased testing facilitates diagnosis and prescription.
• Expansion into Pediatrics: Label extensions for pediatric patients could open new markets.
• Geographical Expansion: Regulatory approvals in additional markets will boost revenues.

Analysts project a compound annual growth rate (CAGR) of approximately 15–20% over the next five years, reaching multibillion-dollar revenues. The growth will heavily depend on clinical trial outcomes, regulatory decisions, and payer coverage.

Pricing and Cost Considerations

High drug pricing sustains revenue but pressures payers and health systems. Roche continues to invest in companion diagnostics, which could enhance drug utilization and promote market share. Cost management strategies and potential biosimilar development (though less relevant for small-molecule targeted therapies) could influence profitability margins.

Pipeline and Future Potential

Ongoing investigations into Rozlytrek's use in broader tumor subtypes and combination regimens could significantly alter its financial outlook. Promising data from trials involving gliomas, pediatric sarcomas, and other cancers suggest expanded indications may emerge, further bolstering sales.

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Strategic Considerations

• Diagnostic Collaborations: Strengthening relationships with genomic testing providers enhances patient identification.
• Market Education: Increasing awareness among oncologists regarding NTRK fusion testing and Rozlytrek’s benefits sustains growth.
• Global Expansion: Prioritizing approval processes in other countries where biomarker testing is expanding will unlock new markets.
• Competitive Positioning: Continuous evidence generation solidifies Rozlytrek’s positioning amidst increasing competition.

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Regulatory and Ethical Factors

Policy shifts favoring personalized medicine and biomarker-driven treatment paradigms will favor drugs like Rozlytrek. Ethical considerations involve equitable access, especially given high costs; thus, engagement with payers and healthcare providers remains crucial.

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Key Takeaways

• Rozlytrek is positioned within a niche but rapidly expanding segment of precision oncology targeting NTRK and ROS1 alterations.
• Market growth hinges on increasing molecular testing, expanding indications, and geographical penetration.
• Revenue forecasts predict healthy CAGR of 15–20% over five years, driven by clinical and regulatory milestones.
• Payer policies and pricing strategies will influence market share and profitability.
• Strategic partnerships, continued clinical research, and global regulatory engagement are critical for maximizing financial trajectory.

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FAQs

1. What are the main drivers of Rozlytrek’s market growth?
Expansion of approved indications, increased biomarker testing, and geographical market penetration are primary growth drivers.

2. How does Rozlytrek compare to its main competitor, Larotrectinib?
While Larotrectinib was first to market, Rozlytrek offers dual activity against NTRK and ROS1, providing a competitive edge in NSCLC.

3. What challenges could impede Rozlytrek’s market expansion?
Limited prevalence of target mutations, high drug costs, payer reimbursement barriers, and emerging competitors could pose hurdles.

4. How important is companion diagnostic availability for Rozlytrek’s sales?
Vital; broader diagnostic integration facilitates patient identification, directly impacting sales volume.

5. What future indications could further boost Rozlytrek’s revenue?
Trials evaluating efficacy in gliomas, pediatric cancers, and other solid tumors could expand its use and drive growth.

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References

1. FDA. (2019). Rozlytrek (Entrectinib) approval announcement.
2. Roche. (2022). Annual Report.
3. Global Data. (2022). Oncology targeted therapy market forecast.
4. FDA. (2020). Expanded approval for ROS1-positive NSCLC.
5. Precision Oncology Consortium. (2022). Biomarker testing trends.

Note: This comprehensive analysis synthesizes current market insights and forecasts to aid strategic decision-making for stakeholders involved in Rozlytrek’s commercialization and clinical application.