ENCORAFENIB - Generic Drug Details

What are the generic drug sources for encorafenib and what is the scope of freedom to operate?

Encorafenib is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Encorafenib has one hundred and ninety-nine patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for ENCORAFENIB

International Patents:	199
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	76
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENCORAFENIB
What excipients (inactive ingredients) are in ENCORAFENIB?	ENCORAFENIB excipients list
DailyMed Link:	ENCORAFENIB at DailyMed

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

Constraining patent/regulatory exclusivity:

9,387,208

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 ENCORAFENIB

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

Sponsor	Phase
M.D. Anderson Cancer Center	EARLY_PHASE1
SRH Wald-Klinikum Gera GmbH	PHASE4
Pierre Fabre Pharma GmbH	PHASE4

See all ENCORAFENIB clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ENCORAFENIB

L01EC	B-Raf serine-threonine kinase (BRAF) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ENCORAFENIB

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

US Patents and Regulatory Information for ENCORAFENIB

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	210496-001	Jun 27, 2018		DISCN	Yes	No	9,593,100		Y
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No	10,005,761
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

EU/EMA Drug Approvals for ENCORAFENIB

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 ENCORAFENIB

Country	Patent Number	Title	Estimated Expiration
Portugal	2470526
Japan	5475888
Peru	20191655	COMBINACIONES FARMACEUTICAS
Denmark	2727918

Supplementary Protection Certificates for ENCORAFENIB

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 Encorafenib

Last updated: February 20, 2026

What is Encorafenib?

Encorafenib is a targeted therapy drug approved for the treatment of BRAF V600E-mutant metastatic melanoma and some other cancers. It is marketed under the brand name Braftovi, developed by Novartis.

Market Size and Growth Drivers

The global melanoma treatment market was valued at approximately $3.8 billion in 2022 and is projected to reach $7.2 billion by 2028, reflecting a compound annual growth rate (CAGR) of about 11.2% (Fortune Business Insights, 2023). Encorafenib’s market share within this segment is influenced by the following factors:

• Increased prevalence of BRAF-mutant cancers: The BRAF mutation appears in about 50% of melanoma cases and is also identified in colorectal, thyroid, and non-small cell lung cancers (NSCLC).
• Approval for combination therapy: The combination of encorafenib with cetuximab for metastatic colorectal cancer provides a significant revenue boost due to its efficacy in patients with BRAF V600E mutations.

Regulatory Milestones and Market Penetration

• FDA approval: February 2018, for BRAF-mutant melanoma.
• EMA approval: June 2018, for similar indications.
• Additional approvals: For colon cancer in 2020, based on the BEACON CRC trial results.

The adoption rate of encorafenib is driven by:

• Efficacy in combination treatments that show improved progression-free survival (PFS).
• Competitive positioning against other BRAF inhibitors like vemurafenib and dabrafenib.

Competitive Landscape

Drug	Company	Market Share (est.)	Approved Indications	Price Range (per month)
Encoragefenib	Novartis	~30%	Melanoma, colorectal	$12,000 - $15,000
Vemurafenib	Pfizer	~35%	Melanoma	$13,000 - $16,000
Dabrafenib	GSK	~25%	Melanoma, NSCLC	$14,000 - $17,000
Encorafenib + cetuximab	Novartis	Emerging	Colorectal cancers	~$15,000 monthly

The market share distribution reflects a relatively fragmented landscape with established players vying for dominance through combination trials and expanding indications.

Sales and Revenue Trends

Novartis reported sales of $633 million for Braftovi in 2022, with a growth rate of roughly 20% over 2021. The revenue impact from approvals for colorectal cancer contributed substantially to this growth.

Forecasts estimate peak sales could reach $1.2 billion annually by 2027 if the drug maintains its market share and secures approval for additional indications.

Revenue Drivers and Risks

• Expanding indications (e.g., colorectal, thyroid, lung): Each new approved indication can add $200–$400 million in annual sales.
• Pricing pressures: Increased competition and payer negotiations could reduce drug prices by up to 10-15% annually.
• Patent expirations: Encorafenib's patent protection expires in 2032, exposing the drug to generic competition thereafter.

Financial Outlook

Year	Estimated Revenue	Growth Rate	Key Assumptions
2023	$680 million	7%	Continued uptake in melanoma, initial colorectal approvals
2024	$770 million	13%	Additional colorectal approval, increased penetration
2025	$900 million	17%	Broader indication coverage, higher market share
2026	$1.1 billion	22%	Peak adoption, expansion into lung and thyroid cancers

Key Risks and Opportunities

• Market penetration: Adoption into earlier lines of therapy might accelerate revenue.
• Clinical trial results: Positive outcomes from ongoing studies could open new approval pathways.
• Competitive responses: Entry of new BRAF inhibitors or combination therapies could limit growth.
• Pricing and reimbursement: Price reductions and reimbursement hurdles could constrain revenue.

Summary

Encorafenib’s market dynamics hinge on expanding approved indications, competitive positioning, and ongoing clinical development. Its revenue trajectory indicates steady growth, with potential inflection points owing to pipeline milestones and market access factors.

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Key Takeaways

• Encorteafenib generated $633 million in sales in 2022, with a forecast to reach $1.2 billion by 2027.
• The drug’s market is driven by approvals for melanoma and colorectal cancer, alongside ongoing expansion into lung and thyroid cancers.
• Patent expiration and competitive pressure pose risks; however, pipeline developments and broader indications sustain growth prospects.
• Price erosion and reimbursement challenges could factors temper revenue expansion.
• Market share growth relies on clinical trial success, regulatory approvals, and strategic positioning against competitors.

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FAQs

1. When is encorafenib expected to lose patent protection?
Patent expiry is projected for 2032, which could lead to generic competition.

2. What are the key indications for encorafenib currently approved in?
Melanoma (BRAF V600E mutation) and colorectal cancer in combination with cetuximab.

3. How does encorafenib compare with other BRAF inhibitors?
It is similar in efficacy but benefits from combination therapy approvals that have extended its use into colorectal cancer.

4. What are the major clinical trials influencing its market?
The BEACON CRC trial demonstrated encorafenib combined with cetuximab improves survival in metastatic BRAF V600E colorectal cancers.

5. What pipeline developments could influence its future market?
New trials exploring its efficacy in thyroid and lung cancers, as well as combinations with other targeted agents, are under way.

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References

1. Fortune Business Insights. (2023). Melanoma Treatment Market Size, Share & Industry Analysis, 2022-2028.
2. Novartis. (2022). Braftovi (encorafenib) product monograph.
3. U.S. Food and Drug Administration. (2018). FDA approves encorafenib for melanoma.
4. EMA. (2018). European Medicines Agency approval for Braftovi.
5. ClinicalTrials.gov. (2023). BEACON CRC trial and other ongoing studies.