Encorafenib - Generic Drug Details

What are the generic 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-six patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for encorafenib

International Patents:	196
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	67
Patent Applications:	1,637
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

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
National Cancer Institute (NCI)	Phase 1
University of Utah	Phase 1/Phase 2
Verastem, Inc.	Phase 1/Phase 2

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

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/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 encorafenib

Country	Patent Number	Title	Estimated Expiration
Hungary	E032847
Ecuador	SP12011700	COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEÍNA
Japan	2013503186
Denmark	2727918
Japan	2015524472	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
Portugal	2727918

Supplementary Protection Certificates for encorafenib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2470526	1990012-5	Sweden		PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; REG. NO/DATE: EU/1/18/1314 20180924
2727918	16/2019	Austria		PRODUCT NAME: KOMBINATION AUS BINIMETINIB UND ENCORAFENIB, JEWEILS IN ALLEN FORMEN EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/18/1314 EU/1/18/1315 (MITTEILUNG) 20180924
2727918	122019000023	Germany
2470526	CA 2019 00012	Denmark		PRODUCT NAME: ENCORAFENIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1314 20180924
2470526	PA2019005,C2470526	Lithuania		PRODUCT NAME: ENKORAFENIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1314 20180920
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

Market Dynamics and Financial Trajectory for Encorafenib

Market Overview

Encorafenib, marketed as BRAFTOVI, is a kinase inhibitor used primarily in the treatment of melanoma and other cancers characterized by the BRAF V600E or V600K mutations. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Global Market Size and Growth

The global encorafenib market is projected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2034. By the end of this period, the market is expected to reach a substantial value, driven by an average growth pattern[1][3].

Regional Analysis

North America

North America dominates the encorafenib market, accounting for more than 45% of the revenue. This dominance is attributed to advanced healthcare infrastructure, high melanoma prevalence, and favorable reimbursement policies that enhance patient access and treatment affordability. The region also experiences fierce competition among pharmaceutical companies, which drives market innovation and dynamics[1].

Europe

Europe is another significant market for encorafenib, driven by the increasing incidence of cancer and government programs supporting cancer research and treatment. The presence of established pharmaceutical companies specializing in oncology therapies ensures a consistent supply and distribution network across the region[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Rising healthcare costs and cancer prevalence in this region drive the demand for encorafenib. The presence of both multinational pharmaceutical companies and local competitors increases competition, promoting market expansion and product accessibility[1].

Key Market Players

Major companies operating in the encorafenib market include Array BioPharma Inc, Pfizer, and the Pierre Fabre Group. Pfizer, in particular, is poised to secure a dominant 42% share of the BRAF inhibitors market for melanoma by 2028, highlighting its significant role in cancer therapy[4].

Product Formulations and End-Users

Formulations

Encorafenib is available in various formulations, including tablets and capsules. These formulations offer flexibility in dosing regimens, which is crucial for patient compliance and treatment efficacy[1].

End-Users

The primary end-users of encorafenib include hospitals, clinics, and research institutions. Hospitals and clinics are the main consumers due to the need for specialized care and monitoring in cancer treatment[1].

Distribution Channels

Encorafenib is distributed through various channels, including hospital pharmacies, retail pharmacies, online pharmacies, and specialty clinics. This diverse distribution network ensures widespread accessibility of the drug to patients in need[1].

Clinical Trials and Efficacy

BEACON CRC Trial

The BEACON CRC trial has shown significant improvements in overall survival (OS) and objective response rates (ORR) for patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) treated with the BRAFTOVI Triplet (encorafenib, binimetinib, and cetuximab) and the BRAFTOVI Doublet (encorafenib and cetuximab). These results have been published in The New England Journal of Medicine and highlight the potential of encorafenib in treating mCRC[5].

Safety Profile

While encorafenib has shown promising efficacy, it also comes with certain adverse reactions. Ocular toxicities, such as serous retinopathy, retinal detachment, and macular edema, have been reported in clinical trials. However, these side effects are generally manageable with appropriate monitoring and care[2][5].

Financial Projections

Market Share

Pfizer's BRAFTOVI is expected to command a significant share of the BRAF inhibitors market for melanoma, with projected sales of $424 million by 2028. This dominance underscores Pfizer's commitment to advancing oncological treatments and addresses critical medical needs[4].

Revenue Growth

The global BRAF inhibitors market for melanoma is forecasted to reach over $1 billion in sales by 2028 in eight major markets, including the US, Canada, France, Germany, Italy, Spain, the UK, and Australia. Encorafenib's contribution to this revenue is substantial, driven by its efficacy and market penetration[4].

Competitive Landscape

The encorafenib market is highly competitive, with other BRAF inhibitors like Novartis' Tafinlar (dabrafenib) also vying for market share. However, Pfizer's BRAFTOVI is well-positioned due to its strong clinical trial data and strategic marketing efforts[4].

Regulatory Approvals

The U.S. FDA has accepted and granted priority review to the supplemental New Drug Application (sNDA) for BRAFTOVI in combination with ERBITUX (cetuximab) for the treatment of BRAF V600E-mutant metastatic colorectal cancer. This regulatory approval is crucial for expanding the drug's indications and increasing its market reach[2].

Key Takeaways

• Market Growth: The encorafenib market is expected to grow significantly, driven by increasing cancer prevalence and advanced healthcare infrastructure.
• Regional Dominance: North America leads the market, followed by Europe and the rapidly growing Asia Pacific region.
• Clinical Efficacy: Encorafenib has shown significant improvements in overall survival and objective response rates in clinical trials.
• Financial Projections: Pfizer's BRAFTOVI is projected to secure a dominant market share, contributing substantially to the revenue of the BRAF inhibitors market.
• Regulatory Approvals: Recent FDA approvals and priority reviews are set to expand the drug's indications and market reach.

FAQs

Q: What is encorafenib used for?

Encorafenib is used to treat melanoma and other cancers characterized by the BRAF V600E or V600K mutations. It is also being investigated for use in BRAF V600E-mutant metastatic colorectal cancer.

Q: Which region dominates the encorafenib market?

North America dominates the encorafenib market, accounting for more than 45% of the revenue.

Q: What are the common formulations of encorafenib?

Encorafenib is available in tablet and capsule formulations.

Q: What are the key findings from the BEACON CRC trial?

The BEACON CRC trial showed significant improvements in overall survival and objective response rates for patients treated with the BRAFTOVI Triplet and BRAFTOVI Doublet combinations compared to standard care.

Q: What are the potential side effects of encorafenib?

Encorafenib can cause ocular toxicities such as serous retinopathy, retinal detachment, and macular edema.

Sources

1. We Market Research: "Encorafenib Market Size, Trends, Share, Industry Analysis & Forecast 2024-2034"
2. Pfizer: "U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab)"
3. DataIntelo: "Encorafenib Market Report | Global Forecast From 2023 To 2032"
4. BioPharma Reporter: "Pfizer's Braftovi to command 42% share of BRAF inhibitors market for melanoma by 2028"
5. Pfizer: "Pfizer Presents Interim Analysis Results from Phase 3 BEACON CRC Trial of BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab"

Last updated: 2024-12-16