VITRAKVI Drug Patent Profile

Which patents cover Vitrakvi, and when can generic versions of Vitrakvi launch?

Vitrakvi is a drug marketed by Bayer Hlthcare and Bayer Healthcare and is included in two NDAs. There are twenty patents protecting this drug.

This drug has two hundred and eighty-one patent family members in fifty countries.

The generic ingredient in VITRAKVI is larotrectinib sulfate. Two suppliers are listed for this compound. Additional details are available on the larotrectinib sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vitrakvi

Vitrakvi was eligible for patent challenges on November 26, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 15, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VITRAKVI

International Patents:	281
US Patents:	20
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	5
Patent Applications:	62
Drug Prices:	Drug price information for VITRAKVI
What excipients (inactive ingredients) are in VITRAKVI?	VITRAKVI excipients list
DailyMed Link:	VITRAKVI at DailyMed

See drug prices for VITRAKVI

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

Constraining patent/regulatory exclusivity:

10,799,505

NDA:

210861

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

10,137,127

NDA:

211710

Dosage:

SOLUTION;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 VITRAKVI

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Children's Oncology Group	Phase 2
Bristol-Myers Squibb	Phase 2

See all VITRAKVI clinical trials

Pharmacology for VITRAKVI

Drug Class	Kinase Inhibitor
Mechanism of Action	Tropomyosin Receptor Kinases Inhibitors

US Patents and Regulatory Information for VITRAKVI

VITRAKVI is protected by twenty-one US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,799,505.

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
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	9,782,414
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	9,127,013		Y	Y
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	10,799,505			Y
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	11,337,967
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	8,513,263		Y	Y
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	10,285,993

International Patents for VITRAKVI

When does loss-of-exclusivity occur for VITRAKVI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Denmark

Dominican Republic

Ecuador

European Patent Office

Finland

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Morocco

New Zealand

Nicaragua

Peru

Philippines

Poland

Portugal

Russian Federation

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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 VITRAKVI around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2021000609	MÉTODOS DE TRATAMIENTO CON FÁRMACOS SUSTRATO PARA CYP3A4. (METHODS OF TREATMENT WITH CYP3A4 SUBSTRATE DRUGS.)
Slovenia	2350071
Mexico	386415	USO DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL) PIRROLIDIN-1-IL)- PIRAZOLO [1,5-A] PIRIMIDIN-3-IL) -3-HIDROXIPIRROLIDINA-1- CARBOXAMIDA PARA TRATAR CÁNCERES PEDIÁTRICOS. (METHODS OF TREATING PEDIATRIC CANCERS)
South Korea	20170116220	ＴＲＫ 키나아제 억제제로서 치환된 피라졸로［１,５­ａ］ 피리미딘 화합물 (SUBSTITUTED PYRAZOLO[15-a]PYRIMIDINE COMPOUNDS AS TRK KINASE INHIBITORS)
Denmark	2725028
Australia	2020202100	METHODS OF TREATMENT
Poland	3439663

Supplementary Protection Certificates for VITRAKVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	CA 2020 00013	Denmark		PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923
3106463	2020004	Norway		PRODUCT NAME: LAROTREKTINIB OG/ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV, SAERLIG LAROTREKTINIBSULFAT INKLUDERT LAROTREKTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20191018
3106463	301033	Netherlands		PRODUCT NAME: LAROTRECTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LAROTRECTINIBSULFAAT, MET INBEGRIP VAN LAROTRECTINIBSULFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923
3106463	122020000012	Germany		PRODUCT NAME: LAROTRECTINIB ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, EINSCHLIESSLICH LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919
3106463	C20200005 00308	Estonia		PRODUCT NAME: LAROTREKTINIIB;REG NO/DATE: EU/1/19/1385; 23.09.2019
3106463	11/2020	Austria		PRODUCT NAME: LAROTRECTINIB UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFAT, EINSCHLIESSLICH LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923
3106463	CR 2020 00013	Denmark		PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923

Market Dynamics and Financial Trajectory for VITRAKVI

Introduction to VITRAKVI

VITRAKVI, developed by Loxo Oncology (now part of Bayer), is an oral TRK inhibitor designed to treat adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. This drug targets tumors with specific genetic mutations, offering a targeted therapy for patients with limited treatment options[1].

Market Overview of TRK Inhibitors

The global TRK inhibitors market, though currently at a nascent stage, is poised for significant growth. The approval of VITRAKVI and another TRK inhibitor, Rozlytrek, has set the stage for this expansion. The market is expected to reach over $2 billion by 2026, driven by increasing cancer prevalence, unmet needs for targeted therapies, and rising awareness about these drugs[4].

Key Market Dynamics

Competitive Landscape

The TRK inhibitors market is highly competitive, with major players including AstraZeneca, Pfizer, Bayer, and others. Companies are adopting various strategies such as collaborations, mergers, and acquisitions to stay ahead. For instance, AUM Biosciences has entered into a collaboration agreement for the development of a pan-TRK inhibitor, highlighting the active and dynamic nature of the market[4].

Regulatory Milestones and Development Activities

VITRAKVI has achieved significant regulatory milestones, including approvals in several major markets. The drug's development activities are ongoing, with a focus on pancreatic cancer and other solid tumors. Detailed regulatory and developmental updates are crucial for understanding the drug's market trajectory[1].

Market Size and Forecast

The market size for VITRAKVI is projected to grow substantially over the next decade. The report highlights forecasted sales data from 2023 to 2032, indicating a significant expansion in the market size across the United States, Europe, and Japan. For example, the market size in the United States is expected to increase steadily, driven by the drug's efficacy and the growing need for targeted cancer therapies[1].

Regional Market Analysis

The United States is anticipated to dominate the TRK inhibitors market due to high cancer prevalence, awareness about new treatments, and the presence of major pharmaceutical companies. Favorable reimbursement policies, such as the Vitrakvi Co-Pay program by Bayer, also contribute to the increased adoption of TRK inhibitors in this region[4].

Financial Trajectory

Revenue and Sales

The financial performance of VITRAKVI is closely tied to its market acceptance and sales. As the drug gains more approvals and penetrates deeper into the market, its revenue is expected to increase. The forecasted sales data indicate a steady rise in revenue from 2023 to 2032, reflecting the drug's growing market share and acceptance[1].

Investment and R&D Costs

The development and commercialization of VITRAKVI involve significant investment in research and development (R&D). Pharmaceutical companies must weigh the expected revenue potential against the investment costs. The financial ecosystem of pharmaceutical R&D is complex, involving assessments of commercial potential, investment costs, and strategic fit[3].

Operating Expenses and Profitability

Operating expenses, including R&D, marketing, and administrative costs, play a crucial role in the financial trajectory of VITRAKVI. Companies like Bayer and Eli Lilly, which are involved in the development and marketing of such drugs, report detailed financials that include these expenses. For instance, Eli Lilly's financial reports show significant investments in R&D and marketing, which are essential for the successful launch and maintenance of drugs like VITRAKVI[2].

Impact of Emerging Therapies

The launch of late-stage emerging therapies for pancreatic cancer and other solid tumors will significantly impact the market for VITRAKVI. These new therapies could offer alternative treatment options, potentially affecting the market share of VITRAKVI. However, the unique mechanism of action and targeted therapy offered by VITRAKVI are likely to maintain its competitive edge[1].

Government Initiatives and Reimbursement Policies

Government initiatives and favorable reimbursement policies are critical for the adoption of TRK inhibitors. Policies like the Vitrakvi Co-Pay program help reduce the out-of-pocket costs for patients, increasing the drug's accessibility and adoption rates. These initiatives are expected to boost the market growth of VITRAKVI and other TRK inhibitors[4].

SWOT Analysis

A SWOT analysis of VITRAKVI highlights its strengths, such as its targeted mechanism of action and regulatory approvals. However, it also reveals weaknesses, including the potential competition from emerging therapies and the high development costs. Opportunities include the growing demand for targeted cancer therapies and favorable reimbursement policies. Threats include the competitive landscape and the evolving regulatory environment[1].

Key Takeaways

• Market Growth: The TRK inhibitors market, led by VITRAKVI, is expected to grow significantly, reaching over $2 billion by 2026.
• Regulatory Approvals: VITRAKVI has achieved key regulatory milestones, with ongoing development activities in pancreatic cancer and other solid tumors.
• Financial Performance: The drug's revenue is projected to increase steadily from 2023 to 2032, driven by its efficacy and market acceptance.
• Competitive Landscape: The market is highly competitive, with major pharmaceutical companies adopting various strategies to maintain their market position.
• Government Initiatives: Favorable reimbursement policies and government initiatives are crucial for the drug's adoption and market growth.

FAQs

What is VITRAKVI used for?

VITRAKVI is used to treat adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation.

Which companies are involved in the development and marketing of VITRAKVI?

VITRAKVI is developed by Loxo Oncology, which is now part of Bayer. Other companies like Genentech are also involved in the broader TRK inhibitors market.

What is the projected market size for VITRAKVI by 2032?

The market size for VITRAKVI is expected to grow substantially by 2032, with detailed forecasts available for various regions including the United States, Europe, and Japan.

How does the competitive landscape affect VITRAKVI?

The competitive landscape is highly dynamic, with major pharmaceutical companies competing through collaborations, mergers, and acquisitions. Emerging therapies also pose a potential threat to VITRAKVI's market share.

What role do government initiatives and reimbursement policies play in the adoption of VITRAKVI?

Government initiatives and favorable reimbursement policies, such as the Vitrakvi Co-Pay program, are crucial for reducing out-of-pocket costs and increasing the adoption rates of VITRAKVI.

Sources

1. Research and Markets: VITRAKVI Market Drug Insight and Market Forecast.
2. Eli Lilly Investor Relations: Income Statement - Reported.
3. RAND Corporation: The Financial Ecosystem of Pharmaceutical R&D.
4. PR Newswire: Global TRK Inhibitors Market Report 2021.

Last updated: 2024-12-16