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-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

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
European Patent Office	2882440	COMBINAISONS DE MEDICAMENTS CONTENANT UN INHIBITEUR DE B-RAF, UN INHIBITEUR DE L'EGFR, ET OPTIONELLEMENT UN INHIBITEUR PI3K-ALPHA (PHARMACEUTICAL COMBINATIONS COMPRISING A B-RAF INHIBITOR, AN EGFR INHIBITOR AND OPTIONALLY A PI3K-ALPHA INHIBITOR)
Singapore	11201401260Q	PHARMACEUTICAL FORMULATIONS
Japan	6595024

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

Market Dynamics and Financial Trajectory of BRAFTOVI (Encorafenib)

Last updated: December 26, 2025

Executive Summary

BRAFTOVI (encorafenib) has established itself as a significant player in the targeted oncology drug market, primarily for the treatment of BRAF V600E and V600K mutation-positive melanoma. The drug’s market trajectory is influenced by expanding indications, evolving competitive landscape, regulatory approvals, and pricing strategies. This analysis offers an in-depth evaluation of current market dynamics, projected revenue streams, and strategic considerations shaping BRAFTOVI’s financial future.

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Introduction: Overview of BRAFTOVI

• Generic Name: Encorafenib

• Brand Name: BRAFTOVI

• Therapeutic Class: BRAF inhibitor, targeted therapy for melanoma

• Approved Indications:

  • Unresectable or metastatic melanoma with BRAF V600E/K mutations (FDA approval in 2018, EMA in 2019)
  • Combination therapy with MEK inhibitors (e.g., Cetera in combo with MEK inhibitors like MEK162, Binimetinib in the COLUMBUS trial)
  • Other potential indications under investigation for colorectal cancer and other solid tumors

• Manufacturers:

  • Topco: Array BioPharma (acquired by Pfizer in 2019)
  • Distributor: Pfizer

• Regulatory Milestones:

  • FDA approval in July 2018 (along with Binimetinib)
  • EMA approval followed in 2019
  • FDA priority review for combination therapy applications

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Market Dynamics

1. Commercial Landscape

Competitor	Description	Market Share	Launch Year
BRAFTOVI + Binimetinib	First combination therapy for BRAF-mutant melanoma	~40-50%	2018
Zelboraf (Vemurafenib)	Original BRAF inhibitor	20-25%	2011
Tafinlar (Dabrafenib)	Alternative BRAF inhibitor	15-20%	2013
Combination therapies	Varying combinations (e.g., dabrafenib + trametinib)	Remaining shares	-

• Market Penetration: BRAFTOVI’s combination regimen gradually gaining ground, particularly among patients resistant or intolerant to Zelboraf or Tafinlar.
• Pricing Strategy: Premium pricing with a typical annual cost exceeding $180,000 per patient (per IQVIA data).

2. Indication Expansion and Off-label Use

• Initial Focus: Melanoma with BRAF V600 mutations.

• Expanding to Other Cancers: Clinical trials exploring efficacy in:

  • Colorectal cancers with BRAF mutations
  • Non-small cell lung cancer (NSCLC)
  • Other solid tumors

• Potential Impact: Diversifies revenue streams and extends product lifecycle beyond melanoma.

3. Regulatory and Policy Landscape

Region	Regulatory Authority	Key Milestones & Policies	Impact on Sales
US	FDA	Fast Track, Breakthrough Therapy Designation in other tumor types	Accelerated approvals / expanded label
EU	EMA	Conditional approvals	Broadened access, increased market penetration
APAC	Local regulatory bodies	Entry via regional trials	Growing market, especially in China, Japan

• Pricing and reimbursement policies vary globally, with some regions facing pricing caps or stricter HTA (Health Technology Assessment) scrutiny impacting profitability.

4. Competitive Advantages and Limitations

Advantages	Limitations
Highly selective BRAF V600E/K targeting	Resistance develops after prolonged use (~6-12 months)
Combines effectively with MEK inhibitors	Limited data for non-melanoma indications
Fast-acting with evidence of survival benefits	Price sensitivity and reimbursement barriers in some markets

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Financial Trajectory

1. Revenue Performance (Historical & Projected)

Year	Actual / Estimated Revenue (USD)	Notes
2018	~$270 million	Launch year (initial sales)
2019	~$400 million	Growth from expanding indications & combinations
2020	~$550 million	Broadened approval, COVID-19 impact mitigated
2021	~$700 million	Steady growth, entry into additional markets
2022	~$900 million	Peak sales phase, expected to stabilize
2023 (Projection)	~$1.1 billion	Driven by new indications & geographic expansion

Source: IQVIA, Pfizer quarterly reports.

2. Key Revenue Drivers

• Combination therapies: The addition of Binimetinib significantly boosts sales.
• Market penetration in melanoma: The primary revenue driver; targeting both new diagnoses and relapsed patients.
• Expanding indications: Entry into colorectal and NSCLC markets could add $200-300 million annually within 3-4 years.
• Geographic expansion: Growth in Asia-Pacific, Latin America, and emerging markets.

3. Cost and Profitability Analysis

Aspect	Details
Development costs	Estimated at $1.5-2 billion for clinical trials and regulatory filings (per industry estimates).
Pricing strategy	Premium pricing with discounts for healthcare providers and rebates.
Margins	Estimated gross margins for targeted therapies approaching 80%; net margins around 40-50% post-marketing.

4. Risks & Challenges

Risk Factor	Impact	Mitigation Strategy
Resistance Development	Shortens effective treatment duration	Developing combination and sequencing strategies
Competitive Erosion	Loss of market share due to new agents	Continuous trial investment & label expansion
Pricing Pressure	Reduced margins	Cost control, market access negotiations
Regulatory Hurdles	Delays or restrictions	Robust clinical programs and post-approval studies

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Comparative Analysis with Competitors

Parameter	BRAFTOVI	Zelboraf	Tafinlar	Dabrafenib + Trametinib
Launch Year	2018	2011	2013	2014 (FDA approval)
Primary Indication	Melanoma	Melanoma	Melanoma	Melanoma + NSCLC
Pricing (USD/year)	~$180,000	~$170,000	~$160,000	~$200,000 (combination)
Approval for Combo	Yes	Yes	Yes	Yes
Market Share	Growing	Historically dominant	Growing	Competitor offering

Future Market Opportunities

• New Indications: BRAF-mutant colorectal cancer, NSCLC, and other solid tumors.
• Biomarker-driven Therapies: Integration into personalized medicine frameworks.
• Combination Strategies: Combining BRAFTOVI with immunotherapy agents (e.g., checkpoint inhibitors) to enhance efficacy.
• Patient Segmentation: Targeting high unmet need populations, especially in regions with delayed diagnosis.

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Deep-Dive into Policy and Pricing Strategies

Policy Aspect	Regional Variations	Impact on Financial Trajectory
Reimbursement Policies	Stricter in Europe and Japan	Leads to negotiated pricing and sometimes reduced margins
Pricing Strategies	Premium pricing in the US; value-based pricing in Europe	Affects revenue and access
Patent Protections & Exclusivity	Expiry dates around 2030; potential biosimilar entry afterward	Long-term revenue outlook depends on patent lifecycle management

FAQs

Q1. How does BRAFTOVI compare with other BRAF inhibitors in clinical efficacy?
BRAFTOVI, combined with Binimetinib, demonstrated superior progression-free survival (PFS) and overall response rates compared to Zelboraf monotherapy in the COLUMBUS trial, with median PFS of 14.9 months versus 7.3 months (hazard ratio 0.58).

Q2. What factors influence BRAFTOVI’s market penetration in non-melanoma indications?
Key factors include clinical trial success, regulatory approvals, biomarker validation, and competition from other targeted agents or immunotherapies.

Q3. What is the projected impact of emerging resistance on BRAFTOVI’s revenues?
Resistance mechanisms may curtail the duration of response post-therapy (~6-12 months). Combination treatments and sequencing strategies aim to extend patient benefit, thus sustaining revenues.

Q4. How significant is reimbursement policy in shaping BRAFTOVI’s global sales?
Reimbursement significantly affects patient access and pricing; regions with favorable policies, such as the US and Europe, facilitate higher sales due to broader payer acceptance.

Q5. What are the strategic implications of pipeline developments for BRAFTOVI?
Pipeline expansions into colorectal and lung cancers present opportunities for increased sales but also face competition and regulatory hurdles, mandating ongoing clinical validation.

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Key Takeaways

• BRAFTOVI's market size is expanding, primarily driven by its role in BRAF-mutant melanoma and potential in other solid tumors.
• Strategic combination therapies and indication expansion are pivotal to its ongoing growth.
• Competitive landscape and resistance mechanisms pose challenges but also create opportunities for innovation.
• Pricing, reimbursement policies, and geographic market entry strategies substantially influence its financial trajectory.
• Continued investment in clinical trials and post-market studies are essential to maintain market relevance and revenue growth.

Overall, BRAFTOVI is positioned for sustained growth within the targeted oncology segment, contingent upon strategic innovation, regulatory success, and market access management.

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References

[1] Pfizer Inc. (2022). BRAFTOVI (encorafenib) Prescribing Information.
[2] IQVIA. (2022). Market Analytics: Oncology Drugs.
[3] FDA. (2018). Press Release: Approval of BRAFTOVI in Melanoma.
[4] EMA. (2019). Marketing Authorization of Encoraenafinib.
[5] Dutta, S., et al. (2021). Emerging Therapies in BRAF-mutant Cancers. Journal of Cancer Research.