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CABOMETYX Drug Patent Profile

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

Cabometyx is a drug marketed by Exelixis Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-one patent family members in thirty-two countries.

The generic ingredient in CABOMETYX 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 Cabometyx

Cabometyx 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 six 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 CABOMETYX

International Patents:	231
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	84
Patent Applications:	410
Drug Prices:	Drug price information for CABOMETYX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CABOMETYX
What excipients (inactive ingredients) are in CABOMETYX?	CABOMETYX excipients list
DailyMed Link:	CABOMETYX at DailyMed

See drug prices for CABOMETYX

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

Constraining patent/regulatory exclusivity:

11,298,349

NDA:

208692

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 CABOMETYX

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

Sponsor	Phase
Jun Zhang, MD, PhD	Phase 2
Kura Oncology, Inc.	Phase 1
Mirati Therapeutics Inc.	Phase 1

See all CABOMETYX clinical trials

Pharmacology for CABOMETYX

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for CABOMETYX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CABOMETYX	Tablets	cabozantinib s-malate	20 mg, 40 mg and 60 mg	208692	1	2019-08-16

US Patents and Regulatory Information for CABOMETYX

CABOMETYX is protected by fifteen US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,298,349.

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 Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No	11,091,440		Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes	11,091,440		Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes	11,298,349		Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No	11,091,439			Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No	8,877,776		Y	Y

Expired US Patents for CABOMETYX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016	8,497,284
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016	8,497,284
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016	8,497,284

International Patents for CABOMETYX

When does loss-of-exclusivity occur for CABOMETYX?

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 CABOMETYX around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4019498	PROCÉDÉS DE PRÉPARATION DE COMPOSÉS DE QUINOLÉINE ET COMPOSITIONS PHARMACEUTIQUES CONTENANT CES COMPOSÉS (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
China	110818633	一种苹果酸盐及其晶型 (MALATE SALT AND CRYSTAL FORM THEREOF)
Australia	2020273307	PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
New Zealand	761931	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
Portugal	2213661
China	106420743	C‑MET调节剂药物组合物 (C-MET modulator pharmaceutical compositions)

Supplementary Protection Certificates for CABOMETYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	583	Finland
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	C20140029 00117	Estonia		PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
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	SPC/GB14/052	United Kingdom		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/13/890/001-006 20140326
2213661	1490053-4	Sweden		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/13/890 20140326

CABOMETYX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CABOMETYX

Introduction to CABOMETYX

CABOMETYX, developed by Exelixis, is a targeted therapy that contains the active ingredient cabozantinib. It is approved for the treatment of various types of cancer, including renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and radioactive iodine-refractory differentiated thyroid cancer. Here, we delve into the market dynamics and financial trajectory of CABOMETYX.

Financial Performance of CABOMETYX

Revenue Figures

In the fiscal year 2023, the cabozantinib franchise, which includes CABOMETYX and COMETRIQ, achieved approximately $1.630 billion in U.S. net product revenues. This figure includes $429 million for the fourth quarter of 2023 alone[1][3][5].

Quarterly and Annual Revenues

The strong performance of CABOMETYX has been consistent, with quarterly net product revenues showing significant growth. For instance, in the second quarter of 2023, Exelixis reported nearly $410 million in net revenue, an 18% increase from the prior-year period[2].

Total Revenues and Guidance

For the fiscal year 2023, Exelixis reported total revenues of $1,830 million. The company has provided financial guidance for fiscal year 2024, expecting net product revenues to range between $1,650 million and $1,750 million[3][5].

Market Drivers

Clinical Success and Label Expansions

The success of CABOMETYX is partly due to its strong clinical performance. Recent trials, such as the Phase 3 CABINET and CONTACT-02 trials, have presented encouraging results, which could lead to label expansions into new indications like advanced pancreatic and extra-pancreatic neuroendocrine tumors (NET) and metastatic castration-resistant prostate cancer (mCRPC)[1].

Patent Protection and Generic Delay

Exelixis has successfully settled patent disputes, delaying generic entry for CABOMETYX until 2031. This extension is crucial for maintaining revenue streams and protecting the company's market share[4].

Challenges and Risks

Patent Expirations

Despite the current patent protection, the key patent covering cabozantinib’s composition of matter is set to expire in 2026. This poses a significant risk of declining sales due to generic competition[2].

Market Competition

Exelixis operates in crowded oncology indications, which means CABOMETYX faces competition from other branded drugs. This competition, combined with pricing pressure, could impact future sales[2].

Pipeline and Future Developments

Pipeline Progress

Exelixis is advancing its pipeline with new assets such as zanzalintinib and XB002. These candidates are in various stages of clinical development and offer potential for growth beyond the cabozantinib franchise[3][4].

Clinical Trials and Collaborations

The company is involved in several clinical trials and collaborations, including the evaluation of zanzalintinib in combination with other therapies. These efforts aim to expand the treatment options for patients and drive future revenue growth[1][3].

Financial Health and Strategic Initiatives

Cash Reserves and Investments

Exelixis maintains a healthy financial position, with approximately $1.3 billion in cash and short-term investments as of the second quarter of 2023. This financial strength supports ongoing research and development efforts as well as external business development opportunities[2].

Corporate Restructuring

Exelixis is implementing corporate restructuring to focus research and development resources on clinical-stage and IND-enabling activities. This strategy aims to maximize pipeline success and operational efficiency[3].

Stock Performance and Market Valuation

Stock Surge

Exelixis' stock has surged 51% since July 2023, outperforming broader markets and breaking out of a five-year stagnation. This growth is largely attributed to the strong performance of CABOMETYX and positive pipeline developments[4].

Fair Value Estimate

Despite the strong stock performance, analysts maintain a fair value estimate of $18.90 per share, reflecting a High Uncertainty Rating and no economic moat rating due to the risks associated with patent expirations and market competition[2].

Expert Insights and Market Analysis

Analyst Views

Analysts appreciate Exelixis' financial health and pipeline progress but highlight the risks associated with reliance on a single active ingredient and approaching patent expirations. The combination of these factors supports a High Uncertainty Rating and no-moat rating[2].

Market Outlook

The market outlook for CABOMETYX remains positive in the short term, driven by its strong clinical performance and delayed generic entry. However, long-term success will depend on the company's ability to expand its pipeline and mitigate the risks associated with patent expirations and market competition[4].

Key Takeaways

• Strong Revenue Performance: CABOMETYX has achieved significant revenue growth, with $1.630 billion in U.S. net product revenues for fiscal year 2023.
• Clinical Success: Positive results from clinical trials could lead to label expansions into new indications.
• Patent Protection: Delayed generic entry until 2031 protects revenue streams.
• Pipeline Progress: Exelixis is advancing new assets to diversify its revenue base.
• Financial Health: The company maintains a strong financial position to support R&D and business development.
• Risks and Challenges: Approaching patent expirations and market competition pose significant risks.

Frequently Asked Questions (FAQs)

What are the primary indications for CABOMETYX?

CABOMETYX is approved for the treatment of renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and radioactive iodine-refractory differentiated thyroid cancer.

How has CABOMETYX performed financially in recent years?

CABOMETYX has achieved strong financial performance, with $1.630 billion in U.S. net product revenues for fiscal year 2023 and a quarterly revenue increase of 18% in the second quarter of 2023.

What are the key risks facing CABOMETYX?

The key risks include approaching patent expirations, generic competition, and market competition from other branded drugs.

Is Exelixis expanding its pipeline beyond CABOMETYX?

Yes, Exelixis is advancing new assets such as zanzalintinib and XB002, and is involved in several clinical trials and collaborations to expand its treatment options.

How has Exelixis' stock performed recently?

Exelixis' stock has surged 51% since July 2023, outperforming broader markets and breaking out of a five-year stagnation.

Sources:

1. Exelixis Announces Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Corporate Update - Exelixis IR.
2. Exelixis Earnings: Cabometyx Achieves Strong Sales and Pipeline Makes Progress, Shares Fairly Valued - Morningstar.
3. Exelixis Announces Preliminary Fiscal Year 2023 Financial Results, Provides 2024 Financial Guidance, and Outlines Key Priorities and Milestones for 2024 - Exelixis IR.
4. Exelixis Stays Strong With Cabometyx While New Assets Approach Key Trials - Seeking Alpha.
5. Exelixis Announces Preliminary Fiscal Year 2023 Financial Results, Provides 2024 Financial Guidance, and Outlines Key Priorities and Milestones for 2024 - Business Wire.