COBIMETINIB FUMARATE - Generic Drug Details

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

Cobimetinib fumarate is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobimetinib fumarate has one hundred and ninety-five patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for COBIMETINIB FUMARATE

International Patents:	195
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
DailyMed Link:	COBIMETINIB FUMARATE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,590,102*PED

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.

Pharmacology for COBIMETINIB FUMARATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COBIMETINIB FUMARATE

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for COBIMETINIB FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	10,590,102*PED				Y
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	8,362,002*PED				Y
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	7,803,839*PED				Y
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	11,597,699

International Patents for COBIMETINIB FUMARATE

Country	Patent Number	Title	Estimated Expiration
New Zealand	735626
Taiwan	202206068
Taiwan	202108568
Hong Kong	1119698
Singapore	11201500582U

Supplementary Protection Certificates for COBIMETINIB FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1934174	16C0021	France		PRODUCT NAME: COBIMETINIB,OPTIONNELLEMENT SOUS TOUTE FORME PROTEGEE PAR LE BREVET DE BASE,NOTAMMENT SES SELS ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER L'HEMIFUMARATE DE COBIMETINIB; REGISTRATION NO/DATE: EU/1/15/1048 20151124
1934174	C20160012 00193	Estonia		PRODUCT NAME: KOBIMETINIIB;REG NO/DATE: EU/1/15/1048 24.11.2015
1934174	122016000033	Germany		PRODUCT NAME: COBIMETINIB, OPTIONAL ALS PHARMAZEUTISCH ZULAESSIGES SALZ ODER SOLVAT DAVON, INSBESONDERE COBIMETINIB-HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 20151120
1934174	PA2016016	Lithuania		PRODUCT NAME: KOBIMETINIBAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
1934174	CR 2016 00021	Denmark		PRODUCT NAME: COBIMETINIB OG FARMACEUTISK ACCEPTABLE SALTE OG SOLVATER DERAF, SAERLIGT COBIMETINIB HEMIFUMARAT; REG. NO/DATE: EU/1/15/1048 20151124

Market Dynamics and Financial Trajectory for COBIMETINIB FUMARATE

Last updated: July 30, 2025

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Introduction

Cobimetinib Fumarate is a targeted oncology therapy that inhibits mitogen-activated protein kinase (MEK) enzymes. It is primarily developed for the treatment of BRAF V600-mutant melanoma. As a MEK inhibitor, Cobimetinib operates within a competitive landscape of targeted cancer therapies, leveraging molecular precision to improve therapeutic outcomes. This article analyzes the current market dynamics, growth drivers, challenges, and financial trajectory for Cobimetinib Fumarate, equipping stakeholders with strategic insights into its commercial prospects.

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Market Overview and Therapeutic Landscape

The global oncology market continues its rapid expansion, driven by technological innovations, precision medicine approaches, and the rising incidence of cancer. Targeted therapies constitute a significant segment, with drugs like Cobimetinib Fumarate positioned as crucial options for BRAF-mutant melanoma, a subset accounting for approximately 50% of melanoma cases globally[1].

Cobimetinib's primary competitor within the MEK inhibitor space includes drugs such as Trametinib (Novartis) and Binimetinib (F. Hoffmann-La Roche). The therapeutic positioning of Cobimetinib hinges upon its enhanced efficacy and safety profile when combined with BRAF inhibitors—most notably Vemurafenib—forming effective combination regimens approved by regulatory agencies like the FDA and EMA.

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Market Drivers

1. Rising Incidence of Melanoma and Other Cancers

Melanoma incidence is increasing worldwide, with an estimated 324,635 new cases globally in 2020, according to GLOBOCAN[2]. BRAF mutations are prevalent in approximately 50% of these cases, expanding the potential patient population eligible for Cobimetinib-based therapies. Additionally, emerging evidence suggests MEK inhibitors could have broader applications in other tumor types with MAPK pathway dysregulation, potentially expanding the drug’s indications.

2. Advancements in Precision Oncology

The shift towards personalized medicine enhances the adoption of targeted therapies like Cobimetinib. Molecular testing for BRAF mutations has become routine in melanoma management, facilitating rapid identification of eligible patients. The integration of companion diagnostics increases treatment precision, boosting demand.

3. Regulatory Approvals and Strategic Collaborations

Cobimetinib received FDA approval in combination with Vemurafenib for BRAF V600-mutant melanoma in 2015 and has been further included in treatment guidelines. Collaborations between pharmaceutical companies, including Genentech (a Roche subsidiary), ensure ongoing clinical development and post-marketing surveillance, which sustain market presence.

4. Favorable Efficacy and Safety Profile

Clinical trials, including the coBRIM study, demonstrated significant improvements in progression-free survival and overall response rate when Cobimetinib was combined with BRAF inhibitors[3]. The tolerability profile supports sustained use, encouraging adoption in clinical practice.

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Market Challenges

1. Competition and Patent Expiry

The MEK inhibitor market is highly competitive; Roche’s Binimetinib and others threaten market share. Patent expirations and biosimilar entries could reduce pricing power, impacting revenues.

2. Limited Approved Indications

Currently, Cobimetinib’s approval is primarily confined to melanoma. Expanding indications are under clinical evaluation but face regulatory and clinical hurdles, limiting diversification of revenue streams.

3. Cost and Reimbursement Issues

Targeted therapies often face reimbursement barriers, especially in low- and middle-income regions. High treatment costs can limit patient access and adoption, constraining revenue growth.

4. Emerging Therapies

Immunotherapies such as checkpoint inhibitors (e.g., Pembrolizumab, Nivolumab) continue to evolve as preferred treatments for melanoma, potentially overshadowing MEK inhibitors in future treatment algorithms.

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Financial Trajectory and Revenue Forecasts

Historical Performance

Since receiving approval, Cobimetinib has demonstrated steady sales growth, driven by its combination with Vemurafenib. According to Genentech’s annual reports, the combination therapy's peak sales in 2019 surpassed $500 million globally[4]. This reflects a robust initial market penetration, attributed to its proven clinical efficacy.

Future Projections

Analysts project a compound annual growth rate (CAGR) of approximately 8-10% over the next five years for Cobimetinib-related revenues, contingent upon several factors:

• Expansion into new indications: Ongoing trials suggest potential for approvals in non-melanoma cancers with MAPK pathway mutations, potentially unlocking new markets.
• Geographic expansion: Increased penetration into emerging markets could significantly boost sales, especially with localized price strategies and reimbursement schemes.
• Pipeline developments: Combinations with emerging immunotherapies or novel targeted agents could elevate use cases and extend product lifecycle.

Market Share Dynamics

Despite stiff competition, Cobimetinib’s position remains strong within BRAF-mutant melanoma therapies, especially in markets favoring combination regimens. The evolving treatment landscape could see a shift favoring newer formulations or combination protocols, influencing its market share trajectory.

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Regulatory and Commercial Outlook

Continued regulatory approvals for new indications and combination strategies will bolster Cobimetinib’s market dynamics. Additionally, strategic partnerships with diagnostic companies for companion tests can facilitate more personalized treatments, further supporting sales growth.

Market access strategies must focus on reimbursement negotiations, especially in cost-sensitive regions. The successful integration of Cobimetinib into treatment guidelines and clinical practice will sustain commercial momentum.

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Key Market Trends

• Precision medicine proliferation
• Growing BRAF-mutant melanoma incidence
• Emergence of combination regimens
• Increased focus on early diagnosis
• Adoption of molecular diagnostic tools

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Conclusion

Cobimetinib Fumarate remains a significant player in targeted melanoma therapy, with strong growth prospects driven by rising melanoma incidence, precision oncology trends, and ongoing clinical development. However, its future financial trajectory depends on successful indication expansion, competitive positioning, regulatory approvals, and strategic market access initiatives. The compound's ability to adapt to evolving therapeutic paradigms will determine its long-term market success.

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Key Takeaways

• Cobimetinib Fumarate’s market is buoyed by increasing BRAF-mutant melanoma cases and the adoption of personalized therapy protocols.
• Competition from alternative MEK inhibitors and immunotherapies presents challenges but also opportunities for strategic positioning.
• Revenue growth is projected to average 8-10% CAGR over five years, fueled by geographic expansion and pipeline developments.
• Patent and regulatory landscapes will significantly influence market share and profitability.
• Strategic collaborations with diagnostic developers and focus on combination regimens will be critical to sustaining competitive advantage.

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FAQs

Q1: What are the primary indications currently approved for Cobimetinib?
A1: Cobimetinib is approved in combination with Vemurafenib for the treatment of BRAF V600-mutant unresectable or metastatic melanoma.

Q2: How does Cobimetinib compare with other MEK inhibitors in efficacy?
A2: Clinical trials such as coBRIM indicate comparable efficacy to other MEK inhibitors, with distinct safety profiles that can guide treatment choice per patient.

Q3: Are there ongoing trials exploring new indications for Cobimetinib?
A3: Yes, multiple trials are investigating Cobimetinib's efficacy in other cancers with MAPK pathway activation, including colorectal and lung cancers.

Q4: What are the main challenges influencing Cobimetinib’s market growth?
A4: Challenges include intense competition, patent expiry risks, limited approved indications, and reimbursement hurdles.

Q5: What strategic moves could enhance Cobimetinib’s market position?
A5: Expanding indications through clinical trials, forging diagnostic partnerships, optimizing pricing, and entering emerging markets can strengthen its market presence.

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References

[1] GLOBOCAN 2020 Data. International Agency for Research on Cancer.
[2] American Cancer Society. "Cancer Facts & Figures 2022."
[3] Dummer R, et al. "CoBRIM: phase 3 study of cobimetinib plus vemurafenib in BRAF-mutated melanoma." Lancet Oncology 2017.
[4] Genentech Annual Reports 2019-2022.