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COTELLIC Drug Patent Profile

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

Cotellic is a drug marketed by Genentech Inc and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and eighty-four patent family members in forty-three countries.

The generic ingredient in COTELLIC is cobimetinib fumarate. One supplier is listed for this compound. Additional details are available on the cobimetinib fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Cotellic

Cotellic was eligible for patent challenges on November 10, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for COTELLIC

International Patents:	184
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	35
Patent Applications:	1
Drug Prices:	Drug price information for COTELLIC
What excipients (inactive ingredients) are in COTELLIC?	COTELLIC excipients list
DailyMed Link:	COTELLIC at DailyMed

See drug prices for COTELLIC

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

Constraining patent/regulatory exclusivity:

10,590,102*PED

NDA:

206192

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 COTELLIC

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

Sponsor	Phase
University of Birmingham	Phase 2/Phase 3
Cancer Research UK	Phase 2/Phase 3
Royal Marsden NHS Foundation Trust	Phase 2/Phase 3

See all COTELLIC clinical trials

Pharmacology for COTELLIC

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

US Patents and Regulatory Information for COTELLIC

COTELLIC is protected by seven US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,590,102.

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
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	11,254,649*PED				Y

International Patents for COTELLIC

When does loss-of-exclusivity occur for COTELLIC?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

Taiwan

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 COTELLIC around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2020013162	COMPRIMIDOS DE LIBERACION INMEDIATA QUE CONTIENEN UN FARMACO Y PROCESOS PARA FORMAR LOS COMPRIMIDOS. (IMMEDIATE-RELEASE TABLETS CONTAINING A DRUG AND PROCESSES FOR FORMING THE TABLETS.)
Eurasian Patent Organization	019983	ИНГИБИТОРЫ MEK И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (MEK INHIBITORS AND METHODS OF USING SAME)
China	110251512	包括给药COBIMETINIB和威罗菲尼的黑色素瘤的组合疗法 (Combination therapies for melanoma comprising administering cobimetinib and vemurafinib)

Supplementary Protection Certificates for COTELLIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1934174	C01934174/01	Switzerland		PRODUCT NAME: COBIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65620 24.08.2015
1934174	22/2016	Austria		PRODUCT NAME: COBIMETINIB ALS EIN EINZELNES STEREOISOMER ODER ALS EINE MISCHUNG VON STEREOISOMEREN DAVON, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE UND SOLVATE, INSBESONDERE COBIMETINIB HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 (MITTEILUNG) 20151124
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

COTELLIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COTELLIC (Cobimetinib)

Introduction to COTELLIC

COTELLIC (cobimetinib) is a MEK inhibitor developed by Exelixis and Genentech, a member of the Roche Group. It is used in combination with vemurafenib to treat advanced melanoma with a BRAF V600E or V600K mutation. Here, we delve into the market dynamics and financial trajectory of COTELLIC.

Approval and Clinical Significance

COTELLIC was approved by the FDA for use in combination with vemurafenib based on the phase 3 coBRIM study. This study demonstrated that the combination of COTELLIC and vemurafenib significantly improved progression-free survival (PFS) and overall survival (OS) compared to vemurafenib alone. The combination reduced the risk of disease worsening or death by about half and increased the median PFS to 12.3 months, compared to 7.2 months with vemurafenib alone[1].

Market Position

Global MEK Inhibitors Market

The global MEK inhibitors market, which includes COTELLIC, is expected to surpass $3 billion by 2026. This growth is driven by increasing cancer prevalence, the unmet need for targeted therapies, a crowded pipeline of new drugs, and significant investments by pharmaceutical giants. The market is highly competitive, with key players including Roche, Pfizer, AstraZeneca, and Novartis[4].

Competitive Landscape

COTELLIC operates in a market dominated by targeted therapies, particularly in the treatment of melanoma and other cancers. The combination of COTELLIC with vemurafenib has differentiated itself through its clinical profile, showing improved PFS and OS rates. This differentiation helps in maintaining a competitive edge against other MEK inhibitors and BRAF inhibitors in the market[1].

Financial Performance

Revenue Streams

COTELLIC generates revenue through its sales in the United States and ex-US markets. In the U.S., Exelixis and Genentech co-promote the drug, with Exelixis receiving a share of the profits. Ex-US royalties are also a significant source of revenue. For example, in Q4 2023, Exelixis reported $2.5 million in U.S. profit share and $0.8 million in ex-US COTELLIC royalties[5].

Quarterly and Annual Financials

Exelixis has reported steady financial performance, with significant contributions from COTELLIC. In the third quarter of 2022, Exelixis reported total revenues of $411.7 million, which included net product revenues, license revenues, and collaboration services revenues. The company's GAAP net income for the quarter was $73.2 million, and non-GAAP net income was $102.0 million[2].

Milestone Payments and Licensing

Exelixis also receives milestone payments from its partners, such as Takeda and Ipsen, which contribute to its revenue. For instance, in Q2 2020, Exelixis received $40 million in milestone payments from Takeda and Ipsen related to the commercial sale and initiation of clinical trials[3].

Research and Development Expenses

Exelixis invests heavily in research and development, which includes ongoing and new clinical trials for COTELLIC and other pipeline drugs. In Q4 2023, the company's R&D expenses were $244.7 million, down from $336.8 million in Q4 2022, reflecting a strategic adjustment in spending[5].

Cash and Investments

Exelixis maintains a strong financial position with substantial cash and investments. As of September 30, 2022, the company had $2.1 billion in cash, cash equivalents, restricted cash equivalents, and investments. This financial stability supports ongoing research, development, and marketing efforts for COTELLIC and other products[2].

Market Trends and Growth Opportunities

Increasing Demand for Targeted Therapies

The demand for targeted therapies, including MEK inhibitors like COTELLIC, is increasing due to their specificity and lower side-effect profiles compared to conventional cancer treatments. This trend is expected to continue, driving growth in the MEK inhibitors market[4].

Combination Therapies

COTELLIC's success in combination with vemurafenib highlights the potential for MEK inhibitors in combination therapies. This approach is likely to expand into other cancer types, offering additional growth opportunities for COTELLIC and similar drugs[1].

Challenges and Future Outlook

Competition and Pipeline Dynamics

The MEK inhibitors market is highly competitive, with several key players and a crowded pipeline of new drugs. Exelixis must continue to innovate and differentiate COTELLIC through clinical trials and strategic partnerships to maintain its market position[4].

Regulatory and Reimbursement Environment

Favorable reimbursement policies in regions like the U.S. and Europe support the uptake of novel MEK inhibitors. However, changes in regulatory or reimbursement environments could impact the financial trajectory of COTELLIC[4].

Key Takeaways

• Clinical Significance: COTELLIC, in combination with vemurafenib, significantly improves PFS and OS in patients with advanced melanoma.
• Market Position: COTELLIC operates in a competitive MEK inhibitors market expected to surpass $3 billion by 2026.
• Financial Performance: Exelixis generates revenue from COTELLIC through U.S. profit share, ex-US royalties, and milestone payments.
• Research and Development: Exelixis invests heavily in R&D to support ongoing and new clinical trials.
• Market Trends: Increasing demand for targeted therapies and combination therapies drive growth opportunities for COTELLIC.

FAQs

What is COTELLIC used for?

COTELLIC (cobimetinib) is used in combination with vemurafenib to treat advanced melanoma with a BRAF V600E or V600K mutation.

Who are the key players in the MEK inhibitors market?

Key players in the MEK inhibitors market include Roche, Pfizer, AstraZeneca, Novartis, and Exelixis.

What are the financial highlights of Exelixis related to COTELLIC?

Exelixis reports revenue from COTELLIC through U.S. profit share, ex-US royalties, and milestone payments. In Q4 2023, the company reported $2.5 million in U.S. profit share and $0.8 million in ex-US COTELLIC royalties.

How does COTELLIC differentiate itself in the market?

COTELLIC differentiates itself through its clinical profile, showing improved PFS and OS rates when combined with vemurafenib compared to vemurafenib alone.

What are the growth opportunities for COTELLIC?

Growth opportunities for COTELLIC include increasing demand for targeted therapies and the potential for combination therapies in other cancer types.

Sources

1. FDA Approves COTELLIC™ (Cobimetinib) for use in Combination with Vemurafenib to Treat Advanced Melanoma - Exelixis IR.
2. Exelixis Announces Third Quarter 2022 Financial Results and Provides Corporate Update - Business Wire.
3. Second Quarter 2020 Financial Results - Exelixis IR.
4. Global MEK Inhibitors Market Drug Sales Clinical Trials Insight 2026 - BioSpace.
5. Fourth Quarter & Fiscal Year 2023 Financial Results - Exelixis IR.