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COMETRIQ Drug Patent Profile

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

Cometriq is a drug marketed by Exelixis 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 thirty-one countries.

The generic ingredient in COMETRIQ is cabozantinib s-malate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabozantinib s-malate profile page.

DrugPatentWatch^® Generic Entry Outlook for Cometriq

Cometriq was eligible for patent challenges on November 29, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 10, 2032. This may change due to patent challenges or generic licensing.

There have been five 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 COMETRIQ

International Patents:	184
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	169
Clinical Trials:	55
Patent Applications:	1,902
Drug Prices:	Drug price information for COMETRIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMETRIQ
What excipients (inactive ingredients) are in COMETRIQ?	COMETRIQ excipients list
DailyMed Link:	COMETRIQ at DailyMed

See drug prices for COMETRIQ

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

NDA:

203756

Dosage:

CAPSULE;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 COMETRIQ

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

Sponsor	Phase
Children's Oncology Group	Phase 2/Phase 3
National Cancer Institute (NCI)	Phase 2/Phase 3
OHSU Knight Cancer Institute	Phase 2

See all COMETRIQ clinical trials

Pharmacology for COMETRIQ

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

US Patents and Regulatory Information for COMETRIQ

COMETRIQ is protected by seven US patents.

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
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y	Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes			Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes			Y	Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes			Y	Y

International Patents for COMETRIQ

When does loss-of-exclusivity occur for COMETRIQ?

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

Argentina

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

South Africa

South Korea

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 COMETRIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I577664
Taiwan	I640509
Australia	2016262732	MALATE SALT OF N-(4-{[6,7-BIS(METHYLOXY)QUINOLIN-4-YL]OXY}PHENYL)-N'-(4 -FLUOROPHENYL) CYCLOPROPANE-1,1-DICARBOXAMIDE, AND CRYSTALLINE FORMS THEREOF FOR THE TREATMENT OF CANCER
China	103459373	Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Denmark	2392565
China	110818633	一种苹果酸盐及其晶型 (MALATE SALT AND CRYSTAL FORM THEREOF)

Supplementary Protection Certificates for COMETRIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	14C0067	France		PRODUCT NAME: CABOZANTINIB ET TOUTE FORME THERAPEUTIQUEMENT EQUIVALENTE COUVERTE PAR LE BREVET DE BASE,INCLUANT SES SELS PHARMACEUTIQUEMENT EQUIVALENTS.; REGISTRATION NO/DATE: EU/1/13/890 20140326
2213661	43/2014	Austria		PRODUCT NAME: CABOZANTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/890/001-003 (MITTEILUNG) 20140326
2213661	2014/052	Ireland		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
2213661	C 2014 036	Romania		PRODUCT NAME: CABOZANTINIB SI ORICE FORMA ECHIVALENTA TERAPEUTIC AACESTUIA, INCLUSIV SARURILE ACCEPT DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003; DATE OF FIRST AUTHORISATION IN EEA: 20140321 ABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003;
2213661	CA 2014 00039	Denmark		PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140321
2213661	PA2014033	Lithuania		PRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321

COMETRIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COMETRIQ

Introduction to COMETRIQ

COMETRIQ, also known as cabozantinib, is a tyrosine kinase inhibitor developed by Exelixis for the treatment of various types of cancer, including medullary thyroid cancer (MTC). Here, we delve into the market dynamics and financial trajectory of this significant oncology drug.

Market Size and Growth

The United States thyroid cancer drugs market, which includes COMETRIQ, has been experiencing steady growth. As of 2021, the market size was estimated at USD 120.32 million, increasing to USD 129.51 million in 2022. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 9.52% to reach USD 207.72 million by 2027[1].

Competitive Landscape

The competitive landscape for thyroid cancer drugs is analyzed through the Competitive Strategic Window, which helps vendors identify opportunities for growth. This includes strategies such as mergers and acquisitions, geography expansion, research and development, and new product introductions. COMETRIQ, being a key player in this market, benefits from its strong clinical trial data and approval for treating progressive, metastatic MTC[1].

Clinical Trial Data and Efficacy

Clinical trials have shown that COMETRIQ significantly improves progression-free survival (PFS) in patients with progressive, metastatic MTC. In the EXAM phase 3 pivotal trial, COMETRIQ-treated patients had a median PFS of 11.2 months compared to 4.0 months for those receiving placebo. This statistically significant prolongation in PFS, along with a higher objective response rate, solidifies COMETRIQ's position in the market[4].

Mechanism of Action

COMETRIQ works by inhibiting multiple receptor tyrosine kinases, including RET, MET, VEGFR2, KIT, and FLT3. This mechanism is crucial for its efficacy in treating cancers driven by these kinases, particularly in MTC where RET mutations are common[4].

Financial Performance of Exelixis

Exelixis, the company behind COMETRIQ, has seen significant financial growth driven by the success of its cabozantinib franchise. For the fiscal year 2023, Exelixis reported total revenues of $1,830 million, with net product revenues of $1,628.9 million. This represents an increase from the previous year, primarily due to higher sales volume and an increase in the average net selling price[2].

Quarterly Financial Highlights

• For the fourth quarter of 2023, Exelixis reported net product revenues of $429.3 million, up from $377.4 million in the comparable period in 2022.
• GAAP net income for the fourth quarter of 2023 was $85.5 million, or $0.28 per share, compared to a net loss of $(30.2) million, or $(0.09) per share, in the same period of 2022[2].

Financial Guidance for 2024

Exelixis has provided financial guidance for 2024, which includes:

• Net product revenues expected to be between $1.650 billion and $1.750 billion.
• Cost of goods sold estimated at 4% to 5% of net product revenues.
• Research and development expenses projected between $925 million and $975 million.
• Selling, general, and administrative expenses expected between $425 million and $475 million[2].

Impact of COVID-19

The COVID-19 pandemic has had a profound impact on various industries, including the pharmaceutical sector. The market for thyroid cancer drugs, including COMETRIQ, has seen changes in consumer behavior, demand, and supply chain dynamics. However, the long-term effects of COVID-19 are expected to be managed through ongoing research and strategic adjustments by companies like Exelixis[1].

Market Rewards for Clinical Benefit

The market rewards drugs that offer significant clinical benefits. In the case of oncology drugs like COMETRIQ, the cumulative sales are exponentially higher compared to other therapy areas. For instance, the average cumulative 9-quarter sales for oncology drugs are $1,041 million, significantly higher than other drug cohorts[3].

Safety and Efficacy

The safety and efficacy of COMETRIQ were assessed in the EXAM trial, an international, multi-center, randomized double-blinded controlled trial. The trial demonstrated a statistically significant prolongation in PFS and a higher objective response rate among patients treated with COMETRIQ compared to those receiving placebo[4].

Future Prospects

Given the strong clinical data and financial performance, COMETRIQ is poised for continued growth. The drug's ability to improve PFS in various genetically defined subgroups of MTC patients makes it a valuable treatment option. As Exelixis continues to expand its product portfolio and navigate market dynamics, COMETRIQ is likely to remain a key contributor to the company's financial success.

Key Takeaways

• Market Growth: The U.S. thyroid cancer drugs market, including COMETRIQ, is projected to grow at a CAGR of 9.52% to reach USD 207.72 million by 2027.
• Clinical Efficacy: COMETRIQ significantly improves PFS in patients with progressive, metastatic MTC.
• Financial Performance: Exelixis has seen substantial revenue growth driven by the cabozantinib franchise.
• COVID-19 Impact: The pandemic has affected market dynamics, but long-term strategies are in place to manage these effects.
• Market Rewards: Oncology drugs offering significant clinical benefits, like COMETRIQ, are rewarded with higher sales.

FAQs

What is COMETRIQ used for?

COMETRIQ, or cabozantinib, is used for the treatment of progressive, metastatic medullary thyroid cancer (MTC) and other types of cancer.

How effective is COMETRIQ in treating MTC?

COMETRIQ has been shown to significantly improve progression-free survival (PFS) in patients with progressive, metastatic MTC, with a median PFS of 11.2 months compared to 4.0 months for placebo[4].

What is the financial performance of Exelixis related to COMETRIQ?

Exelixis reported total revenues of $1,830 million for the fiscal year 2023, with net product revenues of $1,628.9 million, driven largely by the success of its cabozantinib franchise[2].

How has COVID-19 impacted the market for thyroid cancer drugs?

COVID-19 has affected consumer behavior, demand, and supply chain dynamics, but companies like Exelixis are managing these effects through ongoing research and strategic adjustments[1].

What are the future prospects for COMETRIQ?

Given its strong clinical data and financial performance, COMETRIQ is expected to continue growing as a valuable treatment option for MTC and potentially other cancers.

Sources

1. United States Thyroid Cancer Drugs Market Research Report 2022 - ResearchAndMarkets.com
2. Exelixis Announces Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Corporate Update - Biospace
3. Antimicrobial Drugs Market Returns Analysis - ASPE
4. Exelixis Presents COMETRIQ™ (cabozantinib) Clinical Trial Data in Patients with Progressive, Metastatic Medullary Thyroid Cancer - Exelixis
5. Exelixis Announces Third Quarter 2023 Financial Results and Provides Corporate Update - Business Wire