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 eighty-four patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for COBIMETINIB FUMARATE

International Patents:	184
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
Patent Applications:	1
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	11,254,649*PED				Y
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	10,478,400*PED				Y
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	11,597,699
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	11,087,354*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

International Patents for COBIMETINIB FUMARATE

Country	Patent Number	Title	Estimated Expiration
Philippines	12015500186	COMBINATION THERAPIES FOR MELANOMA COMPRISING ADMINISTERING COBIMETINIB AND VEMURAFINIB
European Patent Office	3881833	COMPRIMÉS À LIBÉRATION IMMÉDIATE CONTENANT UN MÉDICAMENT ET PROCÉDÉS POUR FORMER LES COMPRIMÉS (IMMEDIATE-RELEASE TABLETS CONTAINING A DRUG AND PROCESSES FOR FORMING THE TABLETS)
New Zealand	567140	Azetidines as MEK inhibitors for the treatment of proliferative diseases
Mexico	2017017037	SAL DE FUMARATO CRISTALINA DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-YODO FENILAMINO) FENIL][3-HIDROXI-3-(PIPERIDIN-2-IL]AZETIDIN-1-IL]-META NONA. (CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODO PHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE.)
Japan	2021035967	（Ｓ）−［３，４−ジフルオロ−２−（２−フルオロ−４−ヨードフェニルアミノ）フェニル］［３−ヒドロキシ−３−（ピペリジン−２−イル）アゼチジン−１−イル］−メタノンの結晶性フマル酸塩 (CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE)
Japan	2020189882	ＭＥＫインヒビターおよびその使用方法 (MEK INHIBITORS AND METHOD FOR USING THE SAME)

Supplementary Protection Certificates for COBIMETINIB FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1934174	364 5005-2016	Slovakia		PRODUCT NAME: KOBIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1048/001 20151124
1934174	132016000050893	Italy		PRODUCT NAME: COBIMETINIB IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE, INCLUSI SALI E SOLVATI FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE COBIMETINIB EMIFUMARATO(COTELLIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1048, 20151124
1934174	93078	Luxembourg		PRODUCT NAME: COBIMETINIB, EVENTUELLEMENT SOUS TOUTE FORME PROTEGEE PAR LE BREVET DE BASE, Y COMPRIS LES SELS ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER HEMIFUMARATE DE COBIMETINIB; FIRST REGISTRATION DATE: 20151124
1934174	C 2016 018	Romania		PRODUCT NAME: SUPPLEMENTARY PROTECTION CERTIFICATE; NATIONAL AUTHORISATION NUMBER: C 2020 015; DATE OF NATIONAL AUTHORISATION: RO; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 2228064; DATE OF FIRST AUTHORISATION IN EEA: 20220530
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
1934174	C201630028	Spain		PRODUCT NAME: COBIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1048; DATE OF AUTHORISATION: 20151120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1048; DATE OF FIRST AUTHORISATION IN EEA: 20151120

COBIMETINIB FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cobimetinib Fumarate

Introduction

Cobimetinib fumarate, a MEK inhibitor, has been a significant player in the treatment of melanoma, particularly when used in combination with vemurafenib. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Overview

The global melanoma therapeutics market, within which cobimetinib fumarate operates, is projected to experience substantial growth. As of 2023, the global melanoma therapeutics market was valued at USD 8.65 billion and is expected to reach USD 19.87 billion by 2032, growing at a CAGR of 10.80%[4].

Key Players

The market for cobimetinib fumarate API is dominated by several key players:

• Alembic Pharma
• BOC Sciences
• AdooQ BioScience[1].

These companies play a crucial role in the production and distribution of cobimetinib fumarate, influencing the market's competitive landscape.

Applications and Types

Cobimetinib fumarate is primarily used in the treatment of:

• Melanoma: Specifically, it is used in combination with vemurafenib for patients with unresectable or metastatic melanoma with BRAF V600 mutations[2].
• Scientific Research: It is also utilized in various research settings to study its efficacy and safety[1].

The drug is available in different packaging types, including 5Kg/Bag and 10Kg/Bag[1].

Clinical Efficacy and Safety

The efficacy and safety of cobimetinib fumarate were established in a randomized, double-blind, active-controlled trial. The combination of cobimetinib with vemurafenib resulted in a statistically significant improvement in median progression-free survival (PFS) of 3.7 months compared to vemurafenib alone[2].

Pharmacokinetics

Cobimetinib fumarate exhibits linear pharmacokinetics with a mean absolute bioavailability of 46%. The median time to achieve peak plasma levels (Tmax) is approximately 2.4 hours, and the mean elimination half-life is around 44 hours[2].

Market Segmentation

The global melanoma therapeutics market, including cobimetinib fumarate, is segmented by:

• Cancer Type: Superficial spreading melanoma, nodular melanoma, lentigo maligna melanoma, acral lentiginous melanoma, amelanotic melanoma, and others[4].
• Geography: North America, Europe, Asia-Pacific, and LAMEA. North America is the largest market, while Europe is expected to be the fastest-growing region[4].

Regional Market Dynamics

• North America: This region is the most significant shareholder in the global melanoma therapeutics industry, driven by favorable reimbursement policies and a high prevalence of skin cancer[4].
• Asia-Pacific: The market in this region is expected to grow at a lucrative rate due to the abundance of clinical research facilities and government programs aimed at improving healthcare infrastructure[4].
• Europe: Expected to be the fastest-growing market, driven by increasing investment in novel therapeutics and a rising demand for effective treatments[4].

Financial Trajectory

The financial outlook for cobimetinib fumarate is promising, given the growing demand for melanoma therapeutics. Here are some key financial indicators:

• Market Growth: The US & Canada market for cobimetinib fumarate API is expected to grow at a significant CAGR from 2023 to 2029, although specific figures are not provided[1].
• Revenue Projections: The broader melanoma therapeutics market is projected to nearly triple from USD 8.65 billion in 2023 to USD 19.87 billion by 2032, indicating a robust financial trajectory for drugs like cobimetinib fumarate[4].

Competitive Landscape

The competitive landscape is characterized by the presence of major pharmaceutical companies investing heavily in research and development. The approval of new drugs, including cobimetinib fumarate, has significantly impacted the market's expansion. Companies are focusing on developing and releasing novel therapeutics, which is expected to stimulate market growth[4].

Regulatory Approvals

Recent regulatory approvals have been a key driver of market expansion. For instance, the FDA approval of cobimetinib fumarate in combination with vemurafenib in 2015 marked a significant milestone in the treatment of melanoma[2].

Challenges and Opportunities

Despite the positive outlook, there are challenges to consider:

• Competition: The entry of new competitors and the rise of generics and biosimilars could impact market dynamics[3].
• Regulatory Pressures: Demands to reduce drug prices and control healthcare costs in various regions could affect profitability[3].
• Innovation: The continuous need for innovation and the development of new modalities present both challenges and opportunities for growth[3].

Key Takeaways

• Growing Market: The global melanoma therapeutics market is expected to grow significantly, driven by increasing demand and regulatory approvals.
• Key Players: Companies like Alembic Pharma, BOC Sciences, and AdooQ BioScience are major players in the cobimetinib fumarate API market.
• Clinical Efficacy: Cobimetinib fumarate has demonstrated significant clinical efficacy when used in combination with vemurafenib.
• Financial Outlook: The financial trajectory for cobimetinib fumarate is positive, with the broader market projected to nearly triple by 2032.

FAQs

Q: What is the primary use of cobimetinib fumarate? A: Cobimetinib fumarate is primarily used in the treatment of unresectable or metastatic melanoma with BRAF V600 mutations, often in combination with vemurafenib[2].

Q: Who are the main players in the cobimetinib fumarate API market? A: The main players include Alembic Pharma, BOC Sciences, and AdooQ BioScience[1].

Q: What is the projected growth rate of the global melanoma therapeutics market? A: The global melanoma therapeutics market is projected to grow at a CAGR of 10.80% from 2023 to 2032[4].

Q: What are the key regions driving the growth of the melanoma therapeutics market? A: North America is the largest market, while Europe is expected to be the fastest-growing region. The Asia-Pacific region is also anticipated to grow at a lucrative rate[4].

Q: What are the challenges facing the cobimetinib fumarate market? A: Challenges include competition from new entrants, regulatory pressures to reduce drug prices, and the need for continuous innovation[3].

Sources

1. Global Cobimetinib Fumarate API Market Insights, Forecast to 2029 - Valuates Reports
2. Cobimetinib NDA 206192/0000 - FDA
3. Annual Report 2019 | CHUGAI PHARMACEUTICAL CO., LTD. - Chugai Pharmaceutical Co., Ltd.
4. Melanoma Therapeutics Market Size, Trends & Growth Analysis | 2032 - Straits Research