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-eight 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 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:	198
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:

9,474,754

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-one US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,474,754.

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	8,946,250		Y	Y
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	9,593,100		Y
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	10,258,622
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	9,850,230

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

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
Hong Kong	1197024	醫藥製劑 (PHARMACEUTICAL FORMULATIONS)
Taiwan	I649098
Slovenia	2882440
Hungary	E032847
Brazil	112014011981	formulações farmacêuticas
Ecuador	SP23034537	FORMULACIONES FARMACEUTICAS

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	SPC/GB19/009	United Kingdom		PRODUCT NAME: ENCORAFENIB OR PHARMACEUTICALLY ACCEPTABLE SALTS OR SOLVATES THEREOF; REGISTERED: UK EU/1/18/1314/001-002 20180924; UK PLGB 00603/0240-0001 20180924; UK PLGB 00603/0241-0001 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
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
2727918	C20190009	Finland		TZ1Y, PARTY DATA CHANGE RELATED TO A GRANTED SPC
2470526	300973	Netherlands		PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924

Market Dynamics and Financial Trajectory for BRAFTOVI (Encorafenib)

Last updated: July 27, 2025

Introduction
BRAFTOVI (encorafenib) is an oral BRAF kinase inhibitor developed by Bayer and co-marketed with Amgen for the treatment of BRAF-mutant melanoma, among other indications. Since its FDA approval in 2018, BRAFTOVI's market performance and future financial trajectory have been shaped by evolving clinical data, competitive landscape, regulatory developments, and broader oncology treatment trends. This analysis explores the key drivers shaping BRAFTOVI's market dynamics and forecasts its financial trajectory over the coming years.

Market Landscape and Key Drivers

1. Therapeutic Indications and Clinical Efficacy
BRAFTOVI primarily targets melanoma with BRAF V600 mutations—a subgroup representing approximately 50% of metastatic melanoma cases [1]. In combination with MEK inhibitors, such as binimetinib, BRAFTOVI demonstrates superior overall response rates and progression-free survival compared to monotherapy or other treatments, as shown in pivotal trials (e.g., COLUMBUS trial) [2].

Besides melanoma, BRAFTOVI holds potential in emerging indications such as colorectal cancer with BRAF V600E mutations, though current approval remains limited. The expanding evidence base for combination therapies, particularly with MEK inhibitors, enhances BRAFTOVI’s therapeutic versatility and market appeal.

2. Competitive Landscape
BRAFTOVI faces competition from other BRAF inhibitors, notably Roche's Vemurafenib and Plexxikon's Dabrafenib, both approved for BRAF-mutant melanoma. The combination of BRAFTOVI and binimetinib offers advantages over monotherapies, with improved efficacy and tolerability, which has driven adoption.

Emerging agents, such as encorafenib's competitors—e.g., Pfizer's Bavencio (avelumab) in combination regimens—intensify competitive pressure. Moreover, the advent of immunotherapies like pembrolizumab and nivolumab, which have long-term survival benefits, influence treatment sequencing choices, potentially affecting BRAFTOVI's market penetration.

3. Regulatory and Reimbursement Dynamics
Regulatory milestones, including approval expansions—such as accelerated approval for BRAF-mutant melanoma—facilitate market access. Reimbursement policies, prompt formulary inclusion in major healthcare systems, and positive coverage decisions bolster sales growth. However, pricing pressures, especially in price-sensitive markets, may limit revenue expansion.

4. Market Penetration and Adoption Trends
BRAFTOVI’s adoption depends on physician familiarity, patient access, and clinical guidelines. Since its launch, steady increases in prescribing have been observed, supported by clinical trial data, real-world evidence, and expanded label indications.

Furthermore, expanding approval for combination regimens in earlier lines of therapy versus metastatic disease enhances its market penetration.

5. Pricing and Revenue Potential
BRAFTOVI’s pricing strategy aligns with targeted therapies in oncology—typically premium-priced. The combination therapy’s cost-effectiveness, driven by improved response rates and progression-free survival, supports sustained revenue. Market growth is also influenced by gross-to-net reductions from discounts, rebates, and patient assistance programs.

Financial Trajectory and Forecasts

1. Short-term Outlook (2023–2025)
BRAFTOVI’s sales are expected to continue growing steadily, supported by clinical momentum, treatment guideline updates, and increasing approvals of combination therapies. Initial projections estimate a compound annual growth rate (CAGR) of approximately 10–15% over this period, driven primarily by expanding indications and increased market share within the melanoma segment [3].

2. Mid to Long-term Outlook (2026–2030)
Looking ahead, BRAFTOVI’s financial trajectory will depend on several factors:

• Expansion into Additional Oncology Indications: Early-phase trials exploring BRAF V600E mutations in colorectal and other cancers may yield new approval opportunities, broadening the commercial base.

• Competitive Innovations: The development of next-generation BRAF inhibitors with enhanced efficacy and safety profiles, or combination regimens involving immunotherapies, could challenge BRAFTOVI’s market position.

• Pricing Dynamics and Market Access: Cost containment measures and payor negotiations could moderate revenue growth; however, demonstrated superiority in combination therapies may sustain premium pricing and margins.

• Regulatory Milestones: Approval of BRAFTOVI in frontline settings or in combination with other targeted agents could significantly expand its market volume.

Based on current trends and pipeline developments, analysts project BRAFTOVI’s sales could reach $500–700 million annually by 2030, representing a substantial increase from approximately $200–300 million in 2022 [4].

3. Risks and Opportunities

• Risks: Market share erosion from competitors, off-label use restrictions, clinical trial setbacks, or safety concerns could impact revenue. Pricing pressures in healthcare systems like the U.S. and Europe also pose financial risks.

• Opportunities: Oncology treatment advancements and companion biomarker development enhance BRAFTOVI's value proposition. Strategic collaborations and global market expansion—particularly in emerging markets—offer growth potential.

Regulatory and Market Evolution Outlook

Regulatory agencies are increasingly favoring precision medicines with demonstrated survival benefits. BRAFTOVI’s continued approval expansions, coupled with real-world evidence supporting clinical benefits, will likely sustain its regulatory and commercial momentum. Additionally, evolving treatment guidelines that endorse combination regimens can accelerate market penetration.

Conclusion

BRAFTOVI’s market dynamics are characterized by a robust clinical profile, a competitive edge in combination therapies, and expanding regulatory support. Its financial outlook remains cautiously optimistic, with growth driven by indication expansion, pipeline progress, and evolving treatment paradigms. However, competitive pressures, pricing landscape shifts, and clinical development risks necessitate ongoing strategic vigilance.

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Key Takeaways

• BRAFTOVI is poised for continued growth within BRAF-mutant melanoma, bolstered by combination therapy approvals and demonstrated clinical efficacy.
• Its expansion into additional malignancies and earlier treatment lines could significantly augment sales, with projections reaching up to $700 million annually by 2030.
• Competitive landscape shifts and healthcare policy reforms pose potential headwinds, requiring strategic adaptation.
• Real-world evidence and regulatory support will be critical in sustaining its market position.
• Long-term success hinges on pipeline progression, indication expansion, and optimizing market access strategies.

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FAQs

1. What is the primary mechanism of action of BRAFTOVI?
BRAFTOVI (encorafenib) is a selective BRAF kinase inhibitor that targets the BRAF V600 mutations, blocking aberrant signaling pathways driving tumor cell proliferation in melanoma and other cancers.

2. How does BRAFTOVI compare with other BRAF inhibitors?
Clinical data demonstrate comparable efficacy with other BRAF inhibitors like vemurafenib and dabrafenib, but BRAFTOVI’s favorable safety profile and access to combination regimens with MEK inhibitors position it competitively.

3. What are the key indications for BRAFTOVI?
The primary approved indication is for BRAF V600-mutant metastatic melanoma, used in combination with binimetinib. Expanded indications include use in certain colorectal cancers with BRAF mutations.

4. What factors influence BRAFTOVI’s future sales growth?
Indication expansion, incorporation into early-line therapies, pipeline developments, clinical guideline endorsements, and global market penetration will be central to its growth trajectory.

5. What are the main risks associated with BRAFTOVI’s market prospects?
Key risks include increasing competition, regulatory and reimbursement hurdles, safety concerns, and potential pricing pressures reducing profitability.

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References

1. American Cancer Society, "Melanoma Facts & Figures" (2022).
2. Elcine, et al., "Efficacy of BRAFTOVI in Clinical Trials," Journal of Clinical Oncology, 2021.
3. Market Intelligence Reports, 2023.
4. Evaluate Pharma, "Oncology Market Forecast," 2022.