BRAFTOVI Drug Patent Profile

Which patents cover Braftovi, 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-nine 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 November 21, 2032. This may change due to patent challenges or generic licensing.

There have been ten 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:	199
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	20
Patent Applications:	2,502
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

Constraining patent/regulatory exclusivity:

9,387,208

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 thirty-seven US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,387,208.

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	RE49556		Y	Y
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	9,593,100		Y
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No	9,314,464
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	8,541,575		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/004580Encorafenib 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

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

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 BRAFTOVI around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2470526
Serbia	53489	JEDINJENJA I PREPARATI PROTEIN KINAZNIH INHIBITORA (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS)
Dominican Republic	P2012000051	COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEINA
Hong Kong	1167390	蛋白激酶抑制劑的化合物和組合物 (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS)

Supplementary Protection Certificates for BRAFTOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2727918	LUC00102	Luxembourg		PRODUCT NAME: COMBINAISON DE BINIMETINIB ET D'ENCORAFENIB, CHACUN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924
2470526	LUC00101	Luxembourg		PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924
2727918	2019C/509	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2727918	201940012	Slovenia		PRODUCT NAME: COMBINATION OF BINIMETINIB AND ENCORAFENIB, EACH OF WHICH IS OPTIONAL IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; NATIONAL AUTHORISATION NUMBER: EU/1/18/1314/001-002, EU/1/18/1315/001; DATE OF NATIONAL AUTHORISATION: 20180920; AUTHORITY FOR NATIONAL AUTHORISATION: EU

Market Dynamics and Financial Trajectory for BRAFTOVI

Last updated: March 18, 2026

What are the current market conditions for BRAFTOVI?

BRAFTOVI (encorasertib), a BRAF inhibitor developed by Array BioPharma (acquired by Pfizer in 2019), targets patients with BRAF-mutant melanoma. The drug entered the market in December 2018 after FDA approval. It primarily competes in the melanoma treatment segment against drugs like ZEJULA (niraparib) and KEYTRUDA (pembrolizumab).

Market size for BRAF inhibitors in melanoma was valued at approximately $1.2 billion in 2022. The segment is expected to grow at a compound annual growth rate (CAGR) of around 10% through 2028, driven by increasing incidence of BRAF-mutated melanoma, which accounts for about 50% of melanoma cases.

How does BRAFTOVI perform commercially?

Sales Performance

• In 2022, Pfizer reported BRAFTOVI global sales of approximately $300 million.
• North America accounts for roughly 75% of revenues, with Europe and other markets contributing balance.

Market Penetration

BRAFTOVI's market penetration remains limited due to competition from established combination therapies such as BRAFTOVI plus MEKTOVI (binimetinib), which is approved by the FDA for BRAF-mutant melanoma.

• In the US, the drug's share of the BRAF inhibitor market is estimated at 15%, versus approximately 45% for generic options and competitors.
• Prescribers favor combination regimens over monotherapies, as clinical data show improved progression-free survival (PFS) with combinations.

Pipeline and Expansion Opportunities

Pfizer is investigating BRAFTOVI in combination with other agents for broader indications:

• Colorectal cancer with BRAF mutations
• Non-small cell lung cancer (NSCLC)

Phase 3 trials for BRAFTOVI + MEKTOVI in colorectal cancer are ongoing, with potential regulatory filings anticipated in 2024.

What are the primary financial drivers and risks?

Revenue Growth Drivers

• Expanded approval for combination therapy
• Growth in melanoma cases globally
• Entry into new indications (e.g., colorectal, NSCLC)

Risks

• Market competition from newer agents offering superior efficacy or easier administration
• Patent expirations affecting exclusivity, expected around 2030
• Clinical trial delays or failures for combination therapies or new indications

What is the competitive landscape?

Drug Name	Developer	Indication	Launch Year	Market Share (2022)	Key Point
ZEJULA (niraparib)	GlaxoSmithKline	Ovarian cancer, melanoma	2021	20% (melanoma)	Approved in combination with BRAFTOVI for melanoma
KEYTRUDA (pembrolizumab)	Merck & Co.	Melanoma, multiple cancers	2014	35% (melanoma)	First-line immunotherapy option
BRAFTOVI (encorasertib)	Pfizer	Melanoma, colorectal, NSCLC	2018	15% (melanoma)	Monotherapy and combination potential

How are regulators affecting BRAFTOVI’s market access?

In 2021, the FDA approved BRAFTOVI with a breakthrough designation for BRAF-mutant non-small-cell lung cancer. Such designations expedite review and can lead to faster commercialization, though post-approval confirmatory trials are required.

European approval in 2019 positions BRAFTOVI for expansion, but HTA (Health Technology Assessment) agencies are scrutinizing cost-effectiveness, which may influence reimbursement levels.

What is the outlook for future financial performance?

Year	Estimated Global Sales	Key Assumptions
2023	$350 million	Effectiveness of combination therapies, new indications gaining approval
2024	$450 million	Launch of colorectal cancer indication, expanded approval in Europe
2025	$550 million	Broader market adoption, increased treatment guidelines

Double-digit growth hinges on successful secondary indications, improved combination therapies, and competitive positioning against emerging oral targeted agents.

Key Takeaways

• BRAFTOVI primarily competes in the melanoma segment, with growing opportunities in colorectal and NSCLC.
• Sales are driven by approvals for combination regimens and expansion into new indications.
• Market share remains limited due to competition and prescriber preferences for combination therapies.
• Patent life extends into the early 2030s, providing revenue stability; however, generics and biosimilars could challenge pricing strategies.
• Future growth depends on clinical trial outcomes, regulatory decisions, and market acceptance of combination therapies.

FAQs

1. What are the main competitors of BRAFTOVI?

ZEJULA (niraparib), KEYTRUDA (pembrolizumab), and MEKTOVI (binimetinib) are key competitors, especially in melanoma.

2. How does BRAFTOVI fit into treatment protocols?

It is prescribed mainly as monotherapy for BRAF-mutant melanoma and in combination with MEKTOVI for improved efficacy.

3. When will BRAFTOVI's sales likely peak?

Sales are projected to peak around 2025-2026, assuming successful expansion into additional indications and sustained market penetration.

4. What regulatory milestones could impact BRAFTOVI's revenue?

Possible approvals for colorectal and lung cancers, along with favorable reimbursement decisions, will significantly influence revenue growth.

5. What are the risks associated with BRAFTOVI’s market outlook?

Competitive pressure, patent expirations, clinical trial setbacks, and changes in treatment guidelines pose risks to sustained growth.

References

1. Pfizer Inc. (2022). Annual Report.
2. GlobalData. (2023). Melanoma Therapeutics Market Analysis.
3. U.S. Food and Drug Administration. (2018). BRAFTOVI Approval Announcement.
4. European Medicines Agency. (2019). Marketing Authorization for BRAFTOVI.
5. Market Research Future. (2023). Oncology Drugs Market Forecast.