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-seven 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.

Indicators of Generic Entry

Summary for ROZLYTREK

International Patents:	127
US Patents:	14
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	9
Patent Applications:	364
Drug Prices:	Drug price information 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

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	212725-001	Aug 15, 2019		RX	Yes	No
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes			Y
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes
Genentech Inc	ROZLYTREK	entrectinib	PELLETS;ORAL	218550-001	Oct 20, 2023		RX	Yes	Yes
Genentech Inc	ROZLYTREK	entrectinib	PELLETS;ORAL	218550-001	Oct 20, 2023		RX	Yes	Yes

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/004936 Rozlytrek 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
China	109153669
China	106029073
European Patent Office	3967689
Hong Kong	1141278	作為具有激酶抑制劑活性的取代的吲唑衍生物 (SUBSTITUTED INDAZOLE DERIVATIVES ACTIVE AS KINASE INHIBITORS)
Israel	235761	תהליך להכנת n - [5 - (3, 5 - דיפלואורו - בנזיל) -1h - 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)
Singapore	183049
South Korea	102634514

Supplementary Protection Certificates for ROZLYTREK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3107541	122021000032	Germany		PRODUCT NAME: ENTRECTINIB IN ALLEN DEM GRUNDPATENT ZUGRUNDE LIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/20/1460 20200731
2176231	2020042	Norway		PRODUCT NAME: ENTREKTINIB ELLER ISOMERER TAUTOMERER, ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/20/1460 20200810
2176231	20C1064	France		PRODUCT NAME: ENTRECTINIB OU SES TAUTOMERES OU SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/20/1460 20200803
2176231	301090	Netherlands		PRODUCT NAME: ENTRECTINIB, DAN WEL TAUTOMEREN, OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1460 20200803
2176231	C02176231/01	Switzerland		PRODUCT NAME: ENTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67280 05.11.2020
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	CR 2020 00058	Denmark		PRODUCT NAME: ENTRECTINIB ELLER ISOMERER, TAUTOMERER ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/20/1460 20200803

Market Dynamics and Financial Trajectory for ROZLYTREK

Introduction to ROZLYTREK

ROZLYTREK (entrectinib) is a selective tyrosine kinase inhibitor designed to target the TRK A/B/C and ROS1 proteins, which are involved in the proliferation of certain types of cancer. It is used to treat adult and pediatric patients 12 years and older with solid tumors that have NTRK gene fusions without known acquired resistance mutations, or where surgical resection would result in severe morbidity, and who have progressed following treatment or have no satisfactory alternative therapy[1].

Market Dynamics

Competitive Landscape

The global TRK inhibitors market, where ROZLYTREK operates, is highly competitive. Key players include AstraZeneca, Pfizer, Bayer, Loxo Oncology, Innocare, Ono Pharmaceutical, and Turning Point Therapeutics. These companies have adopted various strategies such as collaborations, mergers, and acquisitions to maintain their market position[4].

Market Growth Drivers

The market for TRK inhibitors is expected to witness significant growth due to several factors:

• Increasing Prevalence of Cancer: The rising incidence of cancer globally is driving the demand for targeted therapies like ROZLYTREK.
• Unmet Need for Targeted Therapy: There is a growing need for specific treatments that target genetic mutations, which ROZLYTREK addresses.
• Government Initiatives and Awareness: Increased awareness about available treatments and government initiatives are expected to boost the market[4].

Regional Market Share

The United States is anticipated to have a dominant share in the TRK inhibitors market due to factors such as high awareness about new drugs, the presence of major pharmaceutical companies, and favorable reimbursement policies, including the ROZLYTREK Co-Pay program by Genentech[4].

Financial Trajectory

Sales Forecast

The global TRK inhibitors market, including ROZLYTREK, is projected to reach a significant value by 2026. Specifically, the market is expected to be around USD 2 billion, driven by the sales of approved drugs like ROZLYTREK and Vitrakvi[4].

Revenue and Sales Analysis

• Current Sales: ROZLYTREK has been contributing to the revenue of its manufacturer, Roche. However, the exact sales figures for ROZLYTREK are not isolated in the publicly available reports but are part of the overall pharmaceutical sales of Roche.
• Forecasted Sales: The report highlights that the market scenario for pancreatic cancer, among other indications, is set to change due to extensive research and incremental healthcare spending. This is expected to expand the market size, enabling drug manufacturers like Roche to increase their market penetration[1].

Financial Performance of Roche

Roche's financial performance provides insight into the broader context of ROZLYTREK's financial trajectory:

• Half-Year Report 2024: Roche reported a core operating profit increase of 4% at constant exchange rates (CER), with core EPS increasing by 9% to CHF 10.23. However, the IFRS net income decreased by 11% due to higher charges for the impairment of intangible assets, including a partial impairment of the product intangible asset for ROZLYTREK[2].
• Operating Free Cash Flow: Roche's operating free cash flow was CHF 8.1 billion, an increase of 9% at CER, which indicates a strong underlying cash generation for the business[2].

Regulatory and Development Activities

Regulatory Milestones

ROZLYTREK has achieved significant regulatory milestones, including approvals for the treatment of NTRK-positive solid tumors. The drug's regulatory status and ongoing development activities are closely monitored, with detailed descriptions provided in reports that highlight its current development scenario[1].

Research and Development

ROZLYTREK is part of extensive research and development activities, particularly in pancreatic cancer across the United States, Europe, and Japan. These activities include late-stage emerging therapies that are expected to impact the market significantly[1].

Challenges and Competitions

Emerging Therapies

The launch of late-stage emerging therapies in the near future is expected to give tough market competition to ROZLYTREK. Other products in development, such as selitrectinib, repotrectinib, and taletrectinib, are also vying for market share in the TRK inhibitors segment[4].

Patent Expiry and Intellectual Property

The report on ROZLYTREK includes information on patents and their expiry timelines, which is crucial for understanding the drug's long-term market position and potential generic competition[1].

Key Takeaways

• Market Growth: The TRK inhibitors market, driven by ROZLYTREK and Vitrakvi, is expected to grow significantly due to increasing cancer prevalence and unmet needs for targeted therapies.
• Financial Performance: Roche's financial reports indicate a strong underlying cash generation and increasing core EPS, despite impairments related to intangible assets.
• Regulatory and Development: ROZLYTREK has achieved significant regulatory milestones and is part of ongoing research and development activities, particularly in pancreatic cancer.
• Competition: The market is highly competitive, with emerging therapies expected to impact ROZLYTREK's market share.

FAQs

What is ROZLYTREK used for?

ROZLYTREK (entrectinib) is used to treat adult and pediatric patients 12 years and older with solid tumors that have NTRK gene fusions without known acquired resistance mutations, or where surgical resection would result in severe morbidity, and who have progressed following treatment or have no satisfactory alternative therapy[1].

Who are the key players in the TRK inhibitors market?

Key players in the TRK inhibitors market include AstraZeneca, Pfizer, Bayer, Loxo Oncology, Innocare, Ono Pharmaceutical, and Turning Point Therapeutics[4].

What is the projected market size for TRK inhibitors by 2026?

The global TRK inhibitors market is expected to reach around USD 2 billion by 2026[4].

How does ROZLYTREK fit into Roche's financial performance?

ROZLYTREK contributes to Roche's pharmaceutical sales, although specific figures are not isolated. Roche's overall financial performance shows strong core operating profits and EPS growth despite impairments related to intangible assets[2].

What are the main drivers of the TRK inhibitors market growth?

The main drivers include the increasing prevalence of cancer, unmet needs for targeted therapies, government initiatives, and favorable reimbursement policies[4].

Sources

1. Research and Markets: ROZLYTREK Market Drug Insight and Market Forecast.
2. Roche: Half-Year Report 2024.
3. Roche: Pharma Day 2022.
4. PR Newswire: Global TRK Inhibitors Market Report 2021.
5. Roche: Finance Report 2022.