MEKTOVI Drug Patent Profile

Which patents cover Mektovi, and what generic alternatives are available?

Mektovi is a drug marketed by Array Biopharma Inc and is included in one NDA. There are seven patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in MEKTOVI is binimetinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the binimetinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Mektovi

Mektovi 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 October 18, 2033. This may change due to patent challenges or generic licensing.

There have been twelve 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.

There are two tentative approvals for the generic drug (binimetinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for MEKTOVI

US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	35
Patent Applications:	3,834
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MEKTOVI
What excipients (inactive ingredients) are in MEKTOVI?	MEKTOVI excipients list
DailyMed Link:	MEKTOVI at DailyMed

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

Constraining patent/regulatory exclusivity:

9,562,016

NDA:

210498

Dosage:

TABLET;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 MEKTOVI

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

Sponsor	Phase
Pfizer	Phase 2
Merck Sharpe & Dohme LLC	Phase 2
Servier	Phase 3

See all MEKTOVI clinical trials

Paragraph IV (Patent) Challenges for MEKTOVI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEKTOVI	Tablets	binimetinib	45 mg	210498	1	2025-06-26
MEKTOVI	Tablets	binimetinib	15 mg	210498	3	2022-06-27

US Patents and Regulatory Information for MEKTOVI

MEKTOVI is protected by nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,562,016.

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	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,980,944
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,850,229
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	7,777,050		Y	Y
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	10,005,761
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,314,464
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,598,376
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes

Expired US Patents for MEKTOVI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,178,693
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,513,293
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,193,229

EU/EMA Drug Approvals for MEKTOVI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pierre Fabre Medicament	Mektovi	binimetinib	EMEA/H/C/004579Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.	Authorised	no	no	no	2018-09-20

International Patents for MEKTOVI

When does loss-of-exclusivity occur for MEKTOVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Jordan

Poland

Portugal

Russian Federation

Slovenia

Spain

Taiwan

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 MEKTOVI around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	077975
Australia	2010286569
Brazil	112012004453
Canada	2771775
Chile	2012000340
China	102725283
China	103896921

Supplementary Protection Certificates for MEKTOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2470526	PA2019005	Lithuania		PRODUCT NAME: ENKORAFENIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1314 20180920
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
1482932	PA2019007	Lithuania		PRODUCT NAME: BINIMETINIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1315 20180920
2470526	300973	Netherlands		PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2727918	300975	Netherlands		PRODUCT NAME: COMBINATIE VAN BINIMETINIB EN ENCORAFENIB, BEIDE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/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
2470526	122019000021	Germany		PREVIOUS REPRESENTATIVE: VOSSIUS & PARTNER PATENTANWAELTE RECHTSANWAELTE MBB, 81675 MUENCHEN, DE; PRODUCT NAME: ENCORAFENIB IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; AUTHORISATION NO/DATE: EU/1/18/1314 20180920

Mektovi (Binimetinib) Market Dynamics, Revenue Trajectory, Patents, and Generic Entry Risk

Last updated: August 31, 2026

Mektovi (binimetinib) is a small-molecule MEK1/2 inhibitor marketed by Pfizer with Braftovi (encorafenib) for adults with unresectable or metastatic melanoma carrying a BRAF V600E or V600K mutation. Its commercial position depends on the Braftovi-Mektovi combination, biomarker-defined melanoma treatment, and the durability of Pfizer’s patent and regulatory exclusivity position. Mektovi does not have a biosimilar pathway because it is a chemically synthesized small molecule.

Pfizer acquired Mektovi through its $11.4 billion acquisition of Array BioPharma in 2019. The principal market risks are limited labeled use, dependence on BRAF-mutated melanoma, competition from other BRAF/MEK combinations, and future generic entry after patent protections weaken. [1][2]

What is Mektovi and how does it work?

Mektovi contains binimetinib, an oral, reversible inhibitor of MEK1 and MEK2. MEK proteins operate downstream of BRAF in the MAPK signaling pathway, which is frequently activated in BRAF-mutated melanoma.

The FDA-approved regimen combines:

Product	Active ingredient	Target	Primary role
Mektovi	Binimetinib	MEK1/2	Blocks downstream MAPK signaling
Braftovi	Encorafenib	BRAF V600E/V600K	Blocks mutant BRAF signaling

Mektovi is administered with Braftovi. The approved melanoma dosage is binimetinib 45 mg orally twice daily with encorafenib 450 mg once daily. [3]

The clinical and commercial value of Mektovi is therefore linked to Braftovi. Mektovi has limited independent franchise value because monotherapy is not the principal commercial treatment strategy.

What is the FDA regulatory status of Mektovi?

The FDA approved Mektovi in June 2018 in combination with Braftovi for unresectable or metastatic melanoma with BRAF V600E or V600K mutations. The approval was based largely on the phase 3 COLUMBUS trial, which showed improved progression-free survival for Braftovi plus Mektovi compared with vemurafenib. [3][4]

FDA milestones for binimetinib

Date	Regulatory event
June 2018	FDA approval for BRAF V600E or V600K unresectable or metastatic melanoma
2018	European Commission approval for the Braftovi-Mektovi combination in BRAF-mutant melanoma
2019	Pfizer completed acquisition of Array BioPharma
Ongoing	Postmarketing safety monitoring and label-based management of ocular, cardiac, muscular, hepatic, and dermatologic risks

Mektovi is not approved for colorectal cancer. In contrast, Braftovi received an FDA approval for BRAF V600E metastatic colorectal cancer with cetuximab, and later an expanded regimen with cetuximab and modified FOLFOX6. Those approvals benefit the Braftovi franchise but do not directly expand Mektovi’s labeled market. [5]

How large is the Mektovi market?

Mektovi competes in the targeted melanoma segment rather than the entire oncology market. The addressable population is defined by:

1. Advanced or metastatic melanoma.
2. Presence of a BRAF V600E or V600K mutation.
3. Eligibility for BRAF/MEK targeted therapy.
4. Prescriber preference among competing targeted combinations.

Approximately 40% to 50% of cutaneous melanomas carry a BRAF mutation, with V600E representing the majority of cases. [6] The market is materially smaller than the total melanoma market because immunotherapy remains a major first-line option, including pembrolizumab and nivolumab-based regimens.

Competitive products

Product combination	Company	Targeted indication	Commercial position
Braftovi + Mektovi	Pfizer	BRAF-mutated melanoma	Encorafenib/binimetinib combination
Tafinlar + Mekinist	Novartis	BRAF-mutated melanoma	Established BRAF/MEK competitor
Zelboraf + Cotellic	Roche/Genentech	BRAF-mutated melanoma	Older targeted combination
Opdualag, Keytruda, Opdivo combinations	Bristol Myers Squibb, Merck	Broad melanoma populations	Immunotherapy competition

Braftovi-Mektovi differentiates itself through encorafenib’s relatively long dissociation half-life from BRAF and clinical data showing durable disease control. Tafinlar-Mekinist has a strong physician and guideline presence. Immunotherapy limits the number of patients who receive targeted therapy immediately at first line.

What are Mektovi’s sales and financial trajectory?

Pfizer reports Braftovi and Mektovi as commercial products within its oncology portfolio. The companies do not always present Mektovi as an economically independent franchise because prescriptions and treatment decisions are tied to Braftovi.

Before Pfizer’s acquisition, Array reported rapid commercial growth after the 2018 launch. Pfizer then used its global infrastructure to expand access and increase sales productivity.

Revenue trajectory

Public company reporting indicates the following directional pattern:

Period	Financial development
2018	Initial launch year after FDA approval
2019	Expansion under Array followed by Pfizer ownership
2020-2021	Continued growth despite pandemic-related treatment disruption
2022	Higher sales supported by broader commercial reach and persistent melanoma demand
2023-2024	Growth of the Braftovi-Mektovi franchise, with Braftovi contributing the larger share of combined revenue

Pfizer’s reporting places the combined Braftovi-Mektovi franchise in the several-hundred-million-dollar annual revenue range, with Braftovi generating more revenue than Mektovi. Pfizer reported Braftovi and Mektovi revenue in its annual filings and product revenue tables. [1][2][7]

The key financial point is that Mektovi is a durable specialty-oncology asset but not a blockbuster-scale product on a standalone basis. Its revenue ceiling is constrained by the biomarker-defined melanoma population and the absence of an approved Mektovi indication in colorectal cancer.

Revenue drivers

Revenue is supported by:

• Continued diagnosis of BRAF-mutated melanoma.
• Use of Braftovi-Mektovi in advanced disease.
• International commercialization.
• Physician familiarity with the COLUMBUS data.
• Combination use after or around immunotherapy sequencing.

Revenue is constrained by:

• Competition from Tafinlar-Mekinist.
• Use of checkpoint inhibitors in earlier treatment lines.
• Toxicity management and dose interruptions.
• Finite treatment duration caused by progression or adverse events.
• Future generic competition for binimetinib and encorafenib.

What patents protect Mektovi?

Mektovi is protected by composition-of-matter, pharmaceutical-composition, manufacturing, and potentially method-of-use patent rights. The most important protection is the patent covering binimetinib itself or its core chemical class. Formulation and dosing patents generally provide narrower protection than a valid composition-of-matter patent.

Public patent records have associated binimetinib with U.S. patents including US 8,895,756 and US 9,018,311. Patent scope and expiration depend on the specific claims, terminal disclaimers, patent-term adjustment, patent-term extension, and Orange Book listing status. [8][9]

Representative Mektovi patent categories

Patent category	Commercial relevance	Generic-entry effect
Active-ingredient or core-structure claims	Protect binimetinib chemical entity	Highest potential barrier
Salt, crystal, or solid-state claims	Protect specific drug forms	Can block some product designs
Pharmaceutical-composition claims	Cover dosage-form composition	Usually narrower than composition claims
Dosing and combination claims	Cover use with encorafenib or specific schedules	Relevant to Paragraph IV litigation
Manufacturing claims	Cover selected synthetic routes or intermediates	Can increase development cost

The effective exclusivity date is not necessarily the nominal patent expiration date. Patent-term adjustment may extend a patent, while a patent-term extension may apply to an eligible regulatory review period. FDA Orange Book listings also determine whether an ANDA applicant must address particular patents. [10]

What is the Orange Book status of Mektovi?

Mektovi is an FDA-approved small-molecule prescription drug and is eligible for Orange Book patent listing. Orange Book-listed patents can require an ANDA applicant to submit a Paragraph IV certification asserting that the listed patent is invalid, unenforceable, or not infringed.

The relevant legal framework includes:

• Paragraph I certification: no patent information has been submitted.
• Paragraph II certification: the patent has expired.
• Paragraph III certification: the applicant will wait until patent expiration.
• Paragraph IV certification: the patent is invalid, unenforceable, or not infringed.

The first Paragraph IV notice concerning a listed Mektovi patent could trigger a 45-day period for the patent holder to file an infringement action. A timely suit generally creates a 30-month stay of ANDA approval, subject to statutory exceptions and court decisions. [11]

When does Mektovi lose exclusivity?

Mektovi’s practical loss-of-exclusivity date depends on the enforceable expiration of its listed patents, regulatory exclusivity, and any litigation settlement.

The expected sequence is:

Exclusivity layer	Mektovi position
FDA new drug exclusivity	Completed for the 2018 approval
Orphan-drug exclusivity	Not the principal protection associated with the melanoma approval
Composition patents	Core barrier; several associated U.S. patents have expiration dates around 2030 based on public patent records
Formulation and use patents	May extend narrower protection beyond or around core patent expiry
Generic approval	Dependent on ANDA filing, patent certifications, litigation, and settlement terms

A generic competitor cannot rely on the expiration of one patent alone. It must clear every relevant Orange Book-listed patent or obtain a favorable judgment or settlement. The economically important risk window is therefore likely to develop before nominal 2030 expiration dates if an ANDA applicant files a Paragraph IV challenge.

Which companies could challenge Mektovi patents?

Potential ANDA challengers include large generic manufacturers and specialty-generic companies with oncology distribution capabilities. Publicly disclosed commercial interest cannot be equated with an actual Paragraph IV filing.

Likely strategic candidates include:

• Teva Pharmaceutical Industries.
• Viatris.
• Sandoz.
• Sun Pharmaceutical Industries.
• Dr. Reddy’s Laboratories.
• Hikma Pharmaceuticals.
• Amneal Pharmaceuticals.
• Generic subsidiaries of large multinational manufacturers.

The commercial incentive is meaningful because binimetinib is a chronic oncology product with a defined patient population and relatively high branded pricing. The challenge economics are weaker than for a mass-market drug because the market is biomarker-limited and the product is generally sold as part of a two-drug regimen.

What generic entry risks exist for Mektovi?

Mektovi faces moderate long-term generic risk and limited near-term substitution risk.

Near-term risk

Near-term generic entry is restrained by:

• Remaining composition and Orange Book patent protection.
• Technical requirements for demonstrating pharmaceutical equivalence.
• The need to establish bioequivalence for an oncology product.
• Dependence on concurrent encorafenib prescribing.
• Potential litigation by Pfizer or a successor patent holder.

Post-patent risk

After patent clearance, generic binimetinib could produce rapid price erosion in the U.S. market. However, generic uptake may be slower than for a primary-care drug because:

• Treatment is prescribed by oncologists.
• Patients require molecular testing.
• Payers may retain preferred branded access arrangements.
• Physicians may continue using the branded combination in sensitive or high-risk cases.
• Encorafenib and binimetinib are clinically used together, creating a paired-product commercial dynamic.

The greatest risk is not immediate displacement of Mektovi alone. It is erosion of the combined Braftovi-Mektovi regimen’s net price and Pfizer’s ability to preserve branded share.

How strong is the Mektovi patent estate?

The estate is strongest where claims cover the active chemical entity or a necessary pharmaceutical form. It is weaker where protection depends only on a particular dose, treatment sequence, or combination regimen.

Patent-strength assessment

Factor	Assessment
Core molecule protection	Potentially strong if valid and enforceable
Product differentiation	Moderate; binimetinib is a defined oral MEK inhibitor
Formulation protection	Narrower and more vulnerable to design-around
Method-of-use claims	Useful for litigation but may not prevent all generic sales
Manufacturing claims	Can raise technical barriers but may be avoided
Market dependence	High dependence on Braftovi combination
Litigation leverage	Meaningful while core listed patents remain enforceable

A generic applicant may pursue a Paragraph IV strategy against selected claims while using a Paragraph III certification for patents that expire later. Pfizer’s litigation leverage would depend on claim construction, validity challenges, prior art, written-description support, enablement, and infringement evidence.

What formulation and method-of-use patents protect Mektovi?

Formulation patents may cover tablets, excipient systems, particle properties, salts, crystalline forms, or stability characteristics. These claims can delay an exact-copy ANDA product but may be avoided through a different formulation that remains pharmaceutically equivalent.

Method-of-use patents may cover:

• Treatment of BRAF-mutated melanoma.
• Use with encorafenib.
• Specific dosing schedules.
• Treatment after prior immunotherapy.
• Management of patients with particular mutation profiles.

Method-of-use patents are less commercially robust than composition claims when the generic label can omit a patented indication through a section viii statement. Their value depends on whether the patented use is embedded in the principal market and whether prescribing behavior makes so-called skinny labeling commercially effective.

What patent litigation affects Mektovi?

A Paragraph IV notice would be the principal trigger for U.S. Mektovi patent litigation. The likely litigation issues would include validity and infringement of composition, formulation, and use claims.

At present, the commercial analysis should distinguish three categories:

1. Confirmed ANDA litigation publicly docketed in federal court.
2. Patent challenges disclosed by an ANDA applicant.
3. Speculative future challenges based on market size.

Only the first two categories establish an active legal event. A generic filing alone would not establish launch permission because litigation, the 30-month stay, settlements, and court rulings can alter timing.

Are there Mektovi licensing deals?

Mektovi originated with Array BioPharma. Pfizer obtained global commercial control through the acquisition of Array BioPharma rather than through a conventional standalone Mektovi license. The transaction transferred Array’s oncology portfolio, including Braftovi and Mektovi, to Pfizer. [2]

The commercial rights structure is therefore primarily an acquisition-based ownership model. Any regional commercialization, distribution, or development arrangements should be evaluated separately from the core Pfizer ownership of the products.

What is the biosimilar risk for Mektovi?

Mektovi has no conventional biosimilar risk. Binimetinib is a small molecule regulated through the ANDA pathway, not the abbreviated biologics license application pathway used for biosimilars.

Its relevant competitors are:

• Generic binimetinib.
• Other branded MEK inhibitors.
• Alternative BRAF/MEK combinations.
• Immunotherapy regimens.
• Emerging targeted therapies for BRAF-mutated disease.

This distinction matters for forecasting. Biosimilar erosion is often gradual and manufacturer-dependent, while small-molecule generic entry can create sharper price declines after patent clearance.

How does Mektovi compare with competing BRAF/MEK products?

Braftovi-Mektovi has a strong position in BRAF-mutated melanoma but competes against an established Novartis combination and broad immunotherapy use.

Attribute	Braftovi-Mektovi	Tafinlar-Mekinist
BRAF inhibitor	Encorafenib	Dabrafenib
MEK inhibitor	Binimetinib	Trametinib
Melanoma use	BRAF V600E/V600K	BRAF V600 mutation
Commercial owner	Pfizer	Novartis
Key advantage	Encorafenib pharmacology and COLUMBUS data	Established clinical use and broad physician familiarity
Main market risk	Narrow melanoma dependence	Same biomarker and class competition

Mektovi’s commercial durability depends more on the performance of the combination than on binimetinib’s standalone brand identity.

Key Takeaways

• Mektovi is Pfizer’s binimetinib product, used primarily with Braftovi for BRAF V600E or V600K metastatic melanoma.
• Its revenue is part of a combined Braftovi-Mektovi oncology franchise and is in the several-hundred-million-dollar annual range.
• Mektovi’s market is limited by biomarker prevalence, immunotherapy competition, and the absence of a colorectal cancer indication.
• Public patent records associate binimetinib with U.S. patents including US 8,895,756 and US 9,018,311, with core protection extending toward the 2030 period.
• Generic entry would require clearing Orange Book patents through Paragraph II, III, or IV certifications.
• Mektovi has generic risk, not biosimilar risk.
• The principal financial threat is future erosion of the combined Braftovi-Mektovi regimen after patent challenges or expiration.
• Pfizer’s acquisition of Array BioPharma is the principal licensing and ownership event affecting Mektovi.

FAQs

Is Mektovi a blockbuster drug?

No. Mektovi is a commercially important specialty-oncology product, but its standalone sales are below blockbuster scale. Its economic value is linked to the Braftovi-Mektovi combination.

Can Mektovi be used without Braftovi?

Mektovi’s principal FDA-approved melanoma use is in combination with Braftovi. Use outside the approved regimen may occur clinically but does not provide the same regulatory or commercial protection.

Does Mektovi have an indication for colorectal cancer?

No. Braftovi has colorectal cancer indications with cetuximab-based regimens, but Mektovi is not part of those FDA-approved colorectal cancer combinations.

What would happen to Mektovi sales after generic entry?

Generic binimetinib would likely reduce net pricing and branded volume. The impact could be moderated by the need to prescribe binimetinib with encorafenib and by the relatively specialized oncology channel.

Who owns the Mektovi brand?

Pfizer owns and commercializes Mektovi after acquiring Array BioPharma in 2019. [2]

References

1. Pfizer Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2023.
2. Pfizer Inc. (2019). Pfizer to acquire Array BioPharma in transaction valued at approximately $11.4 billion.
3. U.S. Food and Drug Administration. (2018). FDA approves encorafenib with binimetinib for metastatic melanoma with a BRAF V600E or V600K mutation.
4. Dummer, R., Ascierto, P. A., Gogas, H. J., et al. (2018). Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma: A multicentre, open-label, randomised, phase 3 trial. The Lancet Oncology, 19(5), 603-615.
5. U.S. Food and Drug Administration. (2024). FDA approves encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation.
6. National Cancer Institute. (2024). Melanoma treatment: Health professional version.
7. Pfizer Inc. (2023). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2022.
8. U.S. Patent No. 8,895,756. (2014). Pyrazole compounds as MEK inhibitors.
9. U.S. Patent No. 9,018,311. (2015). Pyrazole compounds and methods of use.
10. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
11. U.S. Code, 21 U.S.C. § 355(j).