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 thirty 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:	130
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
Royal Marsden NHS Foundation Trust	Phase 2/Phase 3
University of Manchester	Phase 2/Phase 3
Hoffmann-La Roche	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

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
New Zealand	703124	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
South Korea	102718538
Israel	260297	תהליך להכנת n-[5-(5,3-דיפלואורו-בנזיל)-h1-אינדאזול-3-איל]-4-(4-מתיל-פיפראזין-1-איל)-2-(טטראהידרו-פיראן-4-אילאמינו)-בנזאמיד (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)
Brazil	PI0814628	derivados ativos de indazol substituídos como inibidores da quinase

Supplementary Protection Certificates for ROZLYTREK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2176231	C 2020 048	Romania		PRODUCT NAME: ENTRECTINIB SAU IZOMERI, TAUTOMERI SAU SARURILE ACCEPTABILE FARMACEUTIC ALE ACESTORA; NATIONAL AUTHORISATION NUMBER: EU/1/20/1460; DATE OF NATIONAL AUTHORISATION: 20200731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1460; DATE OF FIRST AUTHORISATION IN EEA: 20200731
2176231	20C1064	France		PRODUCT NAME: ENTRECTINIB OU SES TAUTOMERES OU SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/20/1460 20200803
2176231	C02176231/01	Switzerland		PRODUCT NAME: ENTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67280 05.11.2020
3107541	301111	Netherlands		PRODUCT NAME: ENTRECTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1460 20200803

Market Dynamics and Financial Trajectory for Rozlytrek

Last updated: February 19, 2026

What is Rozlytrek and how is it positioned in the market?

Rozlytrek (entrectinib) is an oral, targeted kinase inhibitor developed by Roche targeting NTRK gene fusions, ROS1-positive non-small cell lung cancer (NSCLC), and other solid tumors. Approved by the U.S. Food and Drug Administration (FDA) in August 2019, it positions within the precision oncology segment. Its indication expanded to include adult patients with metastatic ROS1-positive NSCLC and patients with NTRK fusion-positive tumors, regardless of tumor origin.

What are the key drivers shaping Rozlytrek’s market?

• FDA approvals: Initial approval in 2019, expanded indications in 2020 and 2022.
• Diagnostic testing: The necessity for genetic testing to identify NTRK and ROS1 alterations.
• Competitive landscape: The presence of other TKIs like larotrectinib (Vitrakvi) and crizotinib (Xalkori).
• Broader clinical application: Increasing use across multiple solid tumor types with NTRK fusions.
• Regulatory landscape: Approvals in Europe, Japan, and other markets influencing sales potential.

How do Rozlytrek’s sales trends look over recent years?

Year	Estimated Global Sales (USD Million)	Notes
2019	50	Post-approval, limited indications
2020	150	Indication expansion, increased clinical adoption
2021	300	Growing awareness, expanded testing protocols
2022	450	Further indication approvals, increased market penetration

Note: These figures are estimates from industry reports and company disclosures.

What factors influence Rozlytrek’s future revenue potential?

• Market penetration: Growth depends on broad diagnostic testing and physician adoption.
• Indication expansion: New approvals for pediatric or other tumor types will expand revenue.
• Pricing strategy: As a targeted therapy, Rozlytrek commands premium pricing, influenced by market access and reimbursement policies.
• Competition: Vitrakvi (larotrectinib) remains the primary competitor for NTRK-positive tumors, with similar efficacy but different safety profiles and pricing.
• Pipeline developments: Roche’s ongoing research into combination therapies and new indications can extend market opportunity.

How does the competitive landscape impact Rozlytrek?

Competitor	Indication(s)	Market share (~2022)	Differentiators
Vitrakvi (larotrectinib)	NTRK fusion-positive tumors	>60%	Similar efficacy, broader label in some regions
Crizotinib (Xalkori)	ROS1-positive NSCLC	Significant in NSCLC	Established in lung cancer, earlier approval
Entrectinib (Rozlytrek)	NTRK, ROS1-positive tumors	Growing but limited	First approved targeting both NTRK and ROS1, potential benefit in off-label settings

What is the outlook for Rozlytrek’s long-term growth?

• The expansion of indications and increasing use in biomarker-driven therapies will likely sustain growth.
• Market entry barriers, including high testing costs and regulatory hurdles, constrain rapid expansion.
• Competition from other targeted therapies and emerging precision oncology agents may influence market share.
• Developing markets and ongoing clinical trials could introduce new prospects, provided regulatory approval is secured.

What are the risks affecting Rozlytrek's financial trajectory?

• Pricing and reimbursement policies: Price caps or stringent reimbursement standards can limit revenue.
• Diagnostic dependency: Limited testing infrastructure impairs market penetration.
• Competitive landscape: Vitraktri's similar indication portfolio and potential future entrants can erode market share.
• Clinical trial outcomes: Negative or inconclusive trial results could impact developer confidence and market adoption.
• Manufacturing and supply chain: Disruptions pose risks to consistent supply and sales continuity.

Summary of Financial Outlook

Aspect	Viewpoint
Revenue growth rate	Estimated 20-25% CAGR through 2027
Market share	Expected to stabilize around 70% within NTRK and ROS1 markets
Price per treatment course	Approx. USD 150,000, subject to reimbursement policies
License and geographic expansion	Targeted launches in additional countries over next 3-5 years

Key Takeaways

• Rozlytrek's revenue primarily depends on its approval breadth and clinician adoption of genetic testing.
• Competitors like Vitraktri influence market share, while Roche's pipeline offers growth prospects.
• Expansion into additional tumor types and pediatric indications can diversify revenue streams.
• Market access momentum and diagnostic infrastructure are critical enabling factors.
• Long-term growth is contingent on successful clinical trials, regulatory approval, and competitive positioning.

FAQs

1. What are the primary indications for Rozlytrek?
   It targets NTRK gene fusion-positive tumors and ROS1-positive NSCLC.

2. How does Rozlytrek compare to Vitraktri in efficacy?
   Both have demonstrated similar response rates; choice depends on approval indications and safety profiles.

3. What are the main market barriers?
   High diagnostic testing costs, limited access in emerging markets, and competition.

4. How likely is market expansion into other tumor types?
   Ongoing clinical trials exploring additional indications could lead to approvals within 2-4 years.

5. What role do diagnostic tests play in revenue growth?
   Essential; broader and more accessible testing enables identification of eligible patients and increases sales.

References

[1] FDA. (2019). FDA Approval for Rozlytrek (entrectinib).
[2] Roche. (2022). Product information and financial disclosures.
[3] GlobalData. (2022). Oncology Market Report.
[4] IQVIA. (2022). Market Access Data for Targeted Therapies.
[5] ClinicalTrials.gov. (2022). Ongoing studies on entrectinib.