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BRAFTOVI Drug Patent Profile

When do Braftovi patents expire, and what generic alternatives are available?

Braftovi is a drug marketed by Array Biopharma Inc and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-six patent family members in fifty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Braftovi

Braftovi was eligible for patent challenges on June 27, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 5, 2033. 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 BRAFTOVI

International Patents:	196
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	20
Patent Applications:	584
Drug Prices:	Drug price information for BRAFTOVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRAFTOVI
What excipients (inactive ingredients) are in BRAFTOVI?	BRAFTOVI excipients list
DailyMed Link:	BRAFTOVI at DailyMed

See drug prices for BRAFTOVI

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

NDA:

210496

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.

Recent Clinical Trials for BRAFTOVI

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
Deciphera Pharmaceuticals LLC	Phase 1/Phase 2
Pfizer	Phase 2

See all BRAFTOVI clinical trials

Paragraph IV (Patent) Challenges for BRAFTOVI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRAFTOVI	Capsules	encorafenib	75 mg	210496	3	2022-06-27

US Patents and Regulatory Information for BRAFTOVI

BRAFTOVI is protected by twenty-five US patents and three FDA Regulatory Exclusivities.

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
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for BRAFTOVI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pierre Fabre Medicament	Braftovi	encorafenib	EMEA/H/C/004580 Encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy	Authorised	no	no	no	2018-09-19

International Patents for BRAFTOVI

When does loss-of-exclusivity occur for BRAFTOVI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

India

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

Turkey

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 BRAFTOVI around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2020019780	Ｂ−Ｒａｆ阻害薬、ＥＧＦＲ阻害薬及び場合によってはＰＩ３Ｋ−α阻害薬を含む組合せ医薬 (PHARMACEUTICAL COMBINATIONS COMPRISING B-RAF INHIBITOR, AND EGFR INHIBITOR AND OPTIONALLY PI3K-α INHIBITOR)
Poland	2882440
South Korea	20120062839	COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS
Mexico	2015001732	COMBINACIONES FARMACEUTICAS QUE COMPRENDEN UN INHIBIDOR DE B-RAF, UN INHIBIDOR DE EGFR, Y OPCIONALMENTE UN INHIBIDOR DE P13K-ALFA. (PHARMACEUTICAL COMBINATIONS COMPRISING A B-RAF INHIBITOR, AN EGFR INHIBITOR AND OPTIONALLY A PI3K-ALPHA INHIBITOR.)
China	102105459	3,4-diarylpyrazoles as protein kinase inhibitors

Supplementary Protection Certificates for BRAFTOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2470526	122019000021	Germany		PRODUCT NAME: ENCORAFENIB EINSCHLIESSLICH ENCORAFENIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1314 20180920
2470526	19C1013	France		PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2727918	PA2019006	Lithuania		PRODUCT NAME: BINIMETINIBO IR ENKORAFENIBO, KIEKVIENO BET KURIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA, DERINYS; REGISTRATION NO/DATE: EU/1/18/1314, EU/1/18/1835 20190920
2470526	2019/012	Ireland		PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526	1990012-5	Sweden		PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; REG. NO/DATE: EU/1/18/1314 20180924

BRAFTOVI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BRAFTOVI

Introduction

BRAFTOVI, developed by Array BioPharma and now part of Pfizer, is a significant player in the oncology market, particularly for the treatment of cancers with the BRAF V600E mutation. Here, we delve into the market dynamics and financial trajectory of BRAFTOVI, highlighting its clinical efficacy, regulatory approvals, market performance, and financial implications.

Clinical Efficacy and Regulatory Approvals

Long-Term Efficacy in NSCLC

BRAFTOVI, in combination with MEKTOVI (binimetinib), has demonstrated substantial antitumor activity in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC). Long-term follow-up results from the Phase 2 PHAROS clinical trial showed a median progression-free survival (PFS) of 9.3 months and a median overall survival (OS) of 22.7 months in previously treated patients, with a safety profile consistent with previous findings[1][4].

Approval and Indications

The FDA approved BRAFTOVI in combination with MEKTOVI for the treatment of adult patients with metastatic NSCLC with a BRAF V600E mutation in October 2023. This approval was based on the efficacy and safety data from the PHAROS trial. The combination is also approved by the European Commission as of August 2024[1][4].

Market Performance

Competitive Landscape

BRAFTOVI + MEKTOVI is positioned as a standard of care option for patients with BRAF V600E-mutant metastatic NSCLC, offering a competitive edge due to its long-term clinically meaningful response and progression-free survival rates. This positioning is crucial in a market where targeted therapies are increasingly preferred over traditional chemotherapy[1].

Market Reach and Distribution

Pfizer has exclusive rights to BRAFTOVI + MEKTOVI in several regions, including the U.S., Canada, Latin America, Africa, and the Middle East. Other companies, such as Ono Pharmaceutical Co., Ltd., Medison, and Pierre Fabre Laboratories, hold exclusive rights in other regions, ensuring a broad global reach[1].

Financial Trajectory

Revenue Impact

The approval and launch of BRAFTOVI + MEKTOVI have contributed to Pfizer's revenue, although the overall financial impact is part of a broader context. Pfizer's full-year 2023 revenues were significantly impacted by the decline in revenues from COVID-19 related products like Comirnaty and Paxlovid. However, excluding these contributions, Pfizer's revenues grew 7% operationally, indicating potential growth areas like BRAFTOVI[5].

Development and Commercialization Costs

Array BioPharma, before its acquisition by Pfizer, incurred substantial costs in research and development and commercial infrastructure setup for BRAFTOVI + MEKTOVI. The net loss for fiscal 2018 was $147.3 million, primarily due to these increased expenses. However, these investments have paved the way for the drug's successful launch and market penetration[2].

Financial Projections

Given the drug's approval and positive clinical outcomes, BRAFTOVI + MEKTOVI is expected to contribute significantly to Pfizer's oncology revenue stream. The company is on track to deliver cost savings and operational efficiencies, which could further enhance the financial performance of this and other oncology products[5].

Safety and Tolerability

Adverse Events

While BRAFTOVI + MEKTOVI has shown promising efficacy, it is not without side effects. Common adverse reactions include fatigue, nausea, diarrhea, and musculoskeletal pain. However, the safety profile has been consistent with previous findings, and no new safety concerns have been identified in long-term follow-up studies[1][4].

Future Perspectives

Ongoing and Future Clinical Trials

Pfizer is continuing to investigate BRAFTOVI in various settings, including earlier stages of metastatic colorectal cancer and the development of a next-generation brain-penetrant BRAF inhibitor. The Phase 3 BEACON CRC trial has shown significant improvements in overall survival and objective response rates for patients with BRAF V600E-mutant metastatic colorectal cancer, further expanding the potential market for BRAFTOVI[1][3].

Market Expansion

The approval of BRAFTOVI + MEKTOVI in different regions and its inclusion in treatment guidelines will continue to drive market expansion. As more patients are diagnosed with BRAF V600E mutations, the demand for targeted therapies like BRAFTOVI is expected to increase.

Key Takeaways

• Clinical Efficacy: BRAFTOVI + MEKTOVI has demonstrated long-term antitumor activity in patients with BRAF V600E-mutant metastatic NSCLC.
• Regulatory Approvals: Approved by the FDA and European Commission for metastatic NSCLC with a BRAF V600E mutation.
• Market Performance: Positioned as a standard of care option with a broad global reach through various distribution agreements.
• Financial Trajectory: Contributes to Pfizer's revenue growth, despite overall declines in COVID-19 related product revenues.
• Safety and Tolerability: Common adverse reactions are manageable, with no new safety concerns identified in long-term follow-up.
• Future Perspectives: Ongoing and future clinical trials are expected to expand the drug's indications and market.

FAQs

What is BRAFTOVI used for?

BRAFTOVI (encorafenib) is used in combination with MEKTOVI (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

What are the common side effects of BRAFTOVI + MEKTOVI?

Common adverse reactions include fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough.

Has BRAFTOVI + MEKTOVI shown long-term efficacy?

Yes, long-term follow-up results from the Phase 2 PHAROS clinical trial have shown substantial antitumor activity, with a median progression-free survival of 9.3 months and a median overall survival of 22.7 months in previously treated patients.

Who has the rights to commercialize BRAFTOVI + MEKTOVI?

Pfizer has exclusive rights in the U.S., Canada, Latin America, Africa, and the Middle East. Other companies, such as Ono Pharmaceutical Co., Ltd., Medison, and Pierre Fabre Laboratories, hold rights in other regions.

What are the recommended doses for BRAFTOVI + MEKTOVI?

The recommended doses are encorafenib 450 mg orally once daily and binimetinib 45 mg orally twice daily.

Is BRAFTOVI + MEKTOVI approved for other indications?

While primarily approved for BRAF V600E-mutant metastatic NSCLC, BRAFTOVI is also being investigated in other settings, including metastatic colorectal cancer.

Sources

1. Pfizer's BRAFTOVI® + MEKTOVI® Shows Long-Term Clinically Meaningful Response in Patients with BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer. Pfizer.
2. Array BioPharma Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2018. Biospace.
3. Pfizer Presents Interim Analysis Results from Phase 3 BEACON CRC Trial of BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer. Pfizer.
4. FDA Approves Encorafenib with Binimetinib for Metastatic Non-Small Cell Lung Cancer with BRAF V600E Mutation. FDA.
5. Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance. Pfizer.