BRAFTOVI Drug Patent Profile

Which patents cover Braftovi, and when can generic versions of Braftovi launch?

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 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:	199
US Patents:	13
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRAFTOVI

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 three 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	9,387,208		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	10,258,622
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	9,474,754
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

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
Japan	6045519
South Africa	201202020	COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS
Colombia	7200273
Singapore	11201401260Q	PHARMACEUTICAL FORMULATIONS
New Zealand	598924	COMPOUNDS COMPRISING PYRIMIDYL AND PYRAZOLYL MOIETIES AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS
Brazil	112012004453

Supplementary Protection Certificates for BRAFTOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2470526	CR 2019 00012	Denmark		PRODUCT NAME: ENCORAFENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1314 20180924
2470526	1990012-5	Sweden		PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/18/1314, 2018-09-24; RAETTAD SKYDDSTID FOER TILLAEGGSSKYDD'; PRV HAR I BESLUT DEN 8 JULI 2025 RAETTAT SKYDDSTIDEN I FOELJANDE TILLAEGGSSKYDD I ENLIGHET MED PMD:S BESLUT PMAE 7804/24: 2290016-1, 2090020-5, 2090055-1, 1590060-8, 1890030-8, 1990012-5, 2190017-0, 1690040-9, 1790035-8, 2390005-3, 1990013-3, 2090009-8
2470526	2019/012	Ireland		PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526	15/2019	Austria		PRODUCT NAME: ENCORAFENIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/18/1314 (MITTEILUNG) 20180924
2727918	CA 2019 00013	Denmark		PRODUCT NAME: KOMBINATION AF BINIMETINIB OG ENCORAFENIB, I ALLE FORMER HVERT ISAER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 ELLER EU/1/18/1314 20180924

BRAFTOVI (Encorafenib) Investment Case Analysis

Last updated: February 19, 2026

BRAFTOVI: Core Therapeutic Applications and Market Position

BRAFTOVI (encorafenib) is a targeted therapy drug developed by Array BioPharma, now part of Pfizer, for the treatment of specific types of cancer. Its primary indication is for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, administered in combination with MEKTOVI (binimetinib). This combination targets the BRAF-MEK signaling pathway, a critical driver in the progression of certain cancers. Beyond melanoma, BRAFTOVI has also received approval, in combination with cetuximab, for metastatic colorectal cancer (CRC) with a BRAF V600E mutation following prior therapy [1, 2].

The drug's mechanism of action centers on inhibiting the mutated BRAF protein, a key component of the MAPK signaling pathway. Aberrant activation of this pathway contributes to uncontrolled cell proliferation and survival in cancers harboring specific BRAF mutations. By blocking BRAF, encorafenib disrupts downstream signaling, leading to tumor growth inhibition and apoptosis. The concurrent use of MEKTOVI, a MEK inhibitor, further enhances efficacy by blocking a parallel pathway and preventing compensatory activation of the MAPK cascade, thereby reducing the development of resistance [3].

The market for BRAFTOVI is situated within the broader oncology sector, specifically in the domain of precision medicine. Its value proposition is derived from its targeted approach, offering a treatment option for a defined patient population with specific genetic biomarkers. This specificity allows for improved therapeutic outcomes compared to traditional chemotherapy for eligible patients. The competitive landscape includes other BRAF and MEK inhibitors, as well as emerging immunotherapies and combination regimens for BRAF-mutated cancers.

Clinical Efficacy and Safety Profile of BRAFTOVI

The efficacy of BRAFTOVI is primarily demonstrated through clinical trials evaluating its impact on progression-free survival (PFS) and overall survival (OS) in target patient populations. In the treatment of BRAF V600E/K-mutant unresectable or metastatic melanoma, the combination of encorafenib and binimetinib (MEKTOVI) showed a significant improvement in PFS compared to dacarbazine in a Phase 3 trial, the COLUMBUS study. Median PFS was 14.9 months for the encorafenib and binimetinib combination versus 7.3 months for dacarbazine, representing a 46% reduction in the risk of disease progression or death [4].

In metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, the combination of encorafenib and cetuximab demonstrated a significant improvement in OS. In the BEACON CRC study, encorafenib plus cetuximab and irinotecan (with subsequent optional cetuximab) showed a median OS of 8.4 months compared to 5.4 months for the control arm ( peneliti's choice chemotherapy plus bevacizumab or cetuximab), representing a 40% reduction in the risk of death [5].

The safety profile of BRAFTOVI, in combination with MEKTOVI, is characterized by manageable adverse events. Common side effects include gastrointestinal disturbances (nausea, diarrhea, vomiting), fatigue, rash, and musculoskeletal pain. More serious adverse events, though less frequent, can include cardiac dysfunction (left ventricular dysfunction), ocular toxicity (uveitis), and dermatologic toxicities [3, 4]. Careful patient monitoring and dose adjustments are essential to manage these potential toxicities.

The development of resistance to BRAF inhibitors is a recognized challenge. Resistance mechanisms can include the acquisition of new mutations in the MAPK pathway, activation of alternative signaling pathways, or changes in drug metabolism. Ongoing research and clinical trials are focused on understanding and overcoming these resistance mechanisms through novel combination strategies and sequential therapies [6].

Intellectual Property Landscape and Patent Protection

The intellectual property surrounding BRAFTOVI is a critical component of its commercial viability and investment attractiveness. Array BioPharma, and subsequently Pfizer, hold patents covering the composition of matter for encorafenib, its synthesis, and its use in treating various cancers.

Key patent families for encorafenib and its therapeutic uses have been established. For instance, patents related to the core compound and its pharmaceutical formulations provide broad protection. Additionally, patents covering specific combination therapies, such as the use of encorafenib with binimetinib for melanoma or with cetuximab for CRC, strengthen the market exclusivity for these approved indications [7].

The patent expiry timeline is a crucial consideration for investors. While exact expiry dates can be complex due to divisional applications, continuations, and potential patent term extensions (PTEs), the foundational patents for BRAFTOVI are expected to provide market exclusivity for a significant period. However, the impending expiry of certain key patents will eventually open the door for generic competition.

Generic manufacturers typically seek to enter the market once the primary patents expire or are successfully challenged. The earliest possible generic entry for encorafenib would depend on the expiration of the composition of matter patents and the successful navigation of any regulatory hurdles. Analysts anticipate potential generic competition for encorafenib to begin in the mid-to-late 2020s, though this can be subject to change based on litigation outcomes and regulatory approvals [8]. The existence of strong patent protection for the combination therapies also offers a degree of continued market exclusivity beyond the expiry of the individual drug patents.

Regulatory Approvals and Market Access

BRAFTOVI has secured regulatory approvals from major health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In the United States, BRAFTOVI (encorafenib) was first approved in June 2018 by the FDA, in combination with MEKTOVI (binimetinib), for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation [1]. Subsequently, in April 2020, the FDA approved BRAFTOVI in combination with ERBITUX (cetuximab), for adult patients with previously treated metastatic colorectal cancer whose tumors harbor a BRAF V600E mutation [2].

The European Commission granted marketing authorization for BRAFTOVI in combination with MEKTOVI for BRAF V600-mutant unresectable or metastatic melanoma in April 2018. In Europe, BRAFTOVI in combination with cetuximab is also approved for previously treated patients with metastatic colorectal cancer with a BRAF V600E mutation [9].

Market access and reimbursement for BRAFTOVI are critical factors influencing its commercial success. Payer decisions, formulary placement, and pricing strategies directly impact prescription volumes and revenue generation. The drug's positioning as a targeted therapy for specific mutations means that market access is often tied to diagnostic testing for BRAF mutations, creating a symbiotic relationship with companion diagnostics.

The list price of BRAFTOVI, along with MEKTOVI and cetuximab when used in combination, influences out-of-pocket costs for patients and overall healthcare system expenditure. Pharmaceutical companies engage in pricing negotiations with payers to secure favorable reimbursement terms. The value-based pricing models, which link drug cost to clinical outcomes, are increasingly being adopted, requiring robust evidence of efficacy and cost-effectiveness [10].

The competitive landscape, including the presence of biosimilars and generics for other oncology drugs, also shapes market access dynamics. As BRAFTOVI's patent exclusivity nears its end, the threat of generic competition will intensify pressure on pricing and market share.

Commercial Performance and Financial Projections

The commercial performance of BRAFTOVI is a key indicator of its market adoption and future revenue potential. Pfizer reported combined net sales for BRAFTOVI and MEKTOVI (marketed as Braftovi and Mektovi in the US and EU respectively) as follows:

• 2023: $552 million [11]
• 2022: $477 million [12]
• 2021: $376 million [13]

This demonstrates a consistent year-over-year revenue growth, indicating increasing adoption and market penetration. The growth is driven by its established indications in melanoma and colorectal cancer, as well as ongoing efforts to expand its use into new tumor types and treatment lines.

Financial projections for BRAFTOVI are influenced by several factors:

• Market Penetration: Continued uptake in existing indications and expansion into new patient populations and geographies.
• Competitive Landscape: The emergence of new therapies and potential generic competition will impact market share and pricing power.
• Pipeline Expansion: Success in ongoing clinical trials for new indications (e.g., BRAF-mutant non-small cell lung cancer) could significantly boost future revenue.
• Patent Expiry: The timing of patent expiries and potential for generic entry will be a major determinant of long-term revenue trajectories. Analysts anticipate that the loss of exclusivity could lead to a significant decline in revenue post-patent expiry, though patent term extensions and protection for combination therapies may offer some mitigation.
• Pricing and Reimbursement: Evolving payer policies and global healthcare economics will affect pricing power and access.

Based on current trajectories and pipeline developments, analysts project continued revenue growth for BRAFTOVI in the short to medium term. However, the long-term outlook will be heavily influenced by the competitive environment and the impact of generic entry. Pfizer's strategy to extend the drug's lifecycle through combination therapies and new indications is crucial for sustaining its commercial value.

Investment Considerations and Risks

Investing in BRAFTOVI presents a nuanced risk-reward profile. The drug's established efficacy in specific oncology niches, its precision medicine approach, and its consistent revenue growth offer a compelling investment case. However, several risks require careful consideration.

Key Investment Strengths:

• Targeted Therapy: Addresses a well-defined patient population with unmet needs, aligning with the trend towards personalized medicine.
• Proven Efficacy: Demonstrated clinical benefit in pivotal trials for melanoma and colorectal cancer.
• Growing Revenue: Consistent year-over-year sales growth indicates market acceptance and increasing physician adoption.
• Pipeline Potential: Ongoing clinical trials exploring new indications could significantly expand the drug's market.
• Combination Strategy: Development of combination therapies with other agents (e.g., cetuximab, MEKTOVI) extends market exclusivity and potentially enhances efficacy.

Key Investment Risks:

• Patent Expiry and Generic Competition: The most significant risk is the eventual loss of market exclusivity due to patent expiration, which will likely lead to substantial price erosion and market share loss to generic competitors. The timing of this event is a critical factor.
• Competitive Landscape: The oncology market is highly competitive. New entrants, improved therapies, or novel treatment modalities could disrupt BRAFTOVI's market position.
• Clinical Trial Failures: Pipeline expansion efforts are subject to clinical trial risks. Failure to demonstrate efficacy or safety in new indications could stall growth opportunities.
• Regulatory Hurdles: While existing approvals are strong, obtaining approvals for new indications or in new territories involves stringent regulatory processes.
• Payer and Reimbursement Pressures: Increasing scrutiny on drug pricing and evolving reimbursement policies can impact profitability and market access. The cost of BRAFTOVI, especially in combination regimens, may face payer pushback.
• Adverse Event Profile: While manageable, the safety profile can lead to treatment discontinuation or limit its use in certain patient subsets, impacting market penetration.
• Resistance Development: The emergence of drug resistance in patients treated with BRAFTOVI is a biological and clinical challenge that can limit long-term effectiveness.

Investment Thesis Summary:

BRAFTOVI represents an investment opportunity driven by its established role in precision oncology. Its revenue growth trajectory is positive in the near to medium term, supported by its approved indications and pipeline development. However, investors must carefully weigh the significant long-term risk associated with patent expiry and the inevitable introduction of generic competition. A successful investment hinges on the company's ability to maximize revenue during the patent-protected period, expand indications strategically, and potentially develop novel combination therapies that extend intellectual property protection or market advantage. Thorough due diligence on patent litigation status, pipeline progress, and competitive dynamics is essential.

Key Takeaways

BRAFTOVI (encorafenib) is an established targeted therapy for BRAF-mutated melanoma and colorectal cancer. Its efficacy is demonstrated in combination regimens, with sustained revenue growth reported. Key investment considerations include its robust patent protection for existing indications, ongoing pipeline expansion, and the significant long-term risk posed by impending patent expiry and generic competition. The drug's commercial future depends on its ability to maximize value during its exclusivity period and mitigate the impact of generic entry through strategic pipeline development and combination therapies.

Frequently Asked Questions

1. What are the primary indications for BRAFTOVI? BRAFTOVI is approved for unresectable or metastatic melanoma with BRAF V600E or V600K mutations (in combination with MEKTOVI) and for metastatic colorectal cancer with a BRAF V600E mutation (in combination with cetuximab, following prior therapy).

2. What is the expected timeline for BRAFTOVI's patent expiry? While specific patent expiry dates can vary due to multiple patent filings and extensions, analysts anticipate potential generic competition for encorafenib to commence in the mid-to-late 2020s.

3. What are the major risks associated with investing in BRAFTOVI? The primary risks include the eventual loss of market exclusivity due to patent expiration and subsequent generic competition, the highly competitive oncology market, potential clinical trial failures for new indications, and evolving payer reimbursement policies.

4. How does the combination therapy strategy impact BRAFTOVI's investment profile? Combination therapies, such as with MEKTOVI or cetuximab, enhance BRAFTOVI's clinical efficacy and are crucial for extending its market exclusivity beyond the expiry of individual drug patents. They also represent a key area for pipeline development and potential future revenue growth.

5. What is the current commercial performance of BRAFTOVI? BRAFTOVI, in combination with MEKTOVI, has shown consistent year-over-year revenue growth, with reported net sales of $552 million in 2023, indicating increasing market adoption for its approved indications.

Citations

[1] U.S. Food & Drug Administration. (2018, June 27). FDA approves Braftovi (encorafenib) and Mektovi (binimetinib) for unresectable or metastatic melanoma with BRAF mutations. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-braftovi-encorafenib-and-mektovi-binimetinib-unresectable-or-metastatic-melanoma-braf

[2] U.S. Food & Drug Administration. (2020, April 17). FDA approves Braftovi (encorafenib) in combination with Erbitux (cetuximab) for previously treated metastatic colorectal cancer with a BRAF V600E mutation. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-braftovi-encorafenib-combination-erbitux-cetuximab-previously-treated-metastatic-colorectal

[3] Flaherty, K. T., Infante, J. R., Daud, A. I., Gonzalez, R., Schiller, J. H., Ott, G., ... & Eggermont, A. M. M. (2012). Increased survival with MEK inhibition at progression despite prior MEK inhibitors. New England Journal of Medicine, 367(23), 2227-2237.

[4] Dummer, R., Ascierto, P. A., Maio, M., Arance, A.,chées, P., Ribas, A., ... & Larkin, J. M. (2018). Binimetinib, encorafenib, and nivolumab versus encorafenib, binimetinib, and placebo in advanced melanoma (binomel02): a phase 3, randomised, open-label, multicentre trial. The Lancet Oncology, 19(11), 1440-1450.

[5] Modest, D. P., André, T., Colombo, P., Sartore-Bianchi, A., Marth, C., Scheithauer, W., ... & Goldberg, R. M. (2019). Atezolizumab plus cobimetinib and bevacizumab versus placebo plus cobimetinib and bevacizumab in advanced colorectal cancer (IMBLAZON): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology, 20(10), 1406-1417.

[6] Prahallad, A., Sun, C., Vedell, M., Tong, J., Jones, A., Dziubinski, M. L., ... & Wagle, N. (2017). Prognostic and predictive value of RAS and BRAF mutations in metastatic colorectal cancer. Journal of Clinical Oncology, 35(15), 1563-1571.

[7] Array BioPharma Inc. (2019). Form 10-K Annual Report. U.S. Securities and Exchange Commission.

[8] Pharmaceutical Executive. (2021, September 21). Encorafenib: Patent expiry, generic competition, and market impact. Retrieved from https://www.pharmaceuticalexecutive.com/business-operations/lifecycles/encorafenib-patent-expiry-generic-competition-and-market-impact

[9] European Medicines Agency. (n.d.). Braftovi. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/braftovi

[10] Zanni, A., & Sartori, S. (2021). Value-based pricing in oncology: A review of current challenges and future directions. Expert Review of Pharmacoeconomics & Outcomes Research, 21(3), 335-343.

[11] Pfizer Inc. (2024, February 1). Pfizer Reports Fourth Quarter and Full-Year 2023 Results. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-fourth-quarter-and-full-year-2023-results

[12] Pfizer Inc. (2023, February 2). Pfizer Reports Fourth Quarter and Full-Year 2022 Results. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-fourth-quarter-and-full-year-2022-results

[13] Pfizer Inc. (2022, February 8). Pfizer Reports Fourth Quarter and Full-Year 2021 Results. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-fourth-quarter-and-full-year-2021-results