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.

The generic ingredient in CABOMETYX is cabozantinib s-malate. There is one drug master file entry 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 March 26, 2032. This may change due to patent challenges or generic licensing.

There have been nineteen 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

US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	85
Patent Applications:	1,663
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:

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH PREVIOUSLY TREATED, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC, WELL-DIFFERENTIATED PANCREATIC NEUROENDOCRINE TUMORS (PNET)

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
Mirati Therapeutics Inc.	Phase 1
Kura Oncology, 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 twenty US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH PREVIOUSLY TREATED, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC, WELL-DIFFERENTIATED PANCREATIC NEUROENDOCRINE TUMORS (PNET).

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			Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes			Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes			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	208692-001	Apr 25, 2016
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016

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

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

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
Argentina	082252
Argentina	122724
Australia	2011278950

Supplementary Protection Certificates for CABOMETYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	C300678	Netherlands		PRODUCT NAME: CABOZANTINIB EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
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

Cabometyx (cabozantinib) market dynamics and financial trajectory: exclusivity, competition, and revenue-risk map

Last updated: May 26, 2026

Executive summary: Cabometyx (cabozantinib) remains one of the highest-revenue oncology TKI franchises in the US and EU, with revenue supported by multiple label expansions (RCC and later-line settings), penetration in metastatic renal cell carcinoma (mRCC) and other approved indications, and continued payer/physician uptake versus older VEGF-targeted standards. Financial trajectory hinges on (1) remaining patent and exclusivity barriers to generic entry, (2) payer contracting dynamics as new VEGF/IO combinations and next-generation TKIs compete, and (3) ongoing dose and line-of-therapy positioning, especially where Cabometyx is used as a preferred oral option after checkpoint inhibitor exposure.

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What is Cabometyx (cabozantinib) and what are its key approved indications driving revenue?

Cabometyx is an oral small-molecule tyrosine kinase inhibitor (TKI) of VEGFR and other kinases. Its commercial base is driven by metastatic renal cell carcinoma (mRCC) use patterns and label expansion into earlier treatment lines and specific clinical settings where it can be positioned around sequencing with immunotherapy.

Which indications matter most for Cabometyx sales?

Core revenue drivers typically include:

• Metastatic renal cell carcinoma (mRCC) across approved lines of therapy in US and major ex-US markets.
• Additional oncology approvals outside RCC where the drug has established clinical differentiation and/or favorable payer acceptance.

How does sequencing affect Cabometyx’s market share?

Cabometyx’s uptake is sensitive to:

• Post-immunotherapy sequencing in mRCC.
• Choice between VEGF TKIs (cabozantinib, axitinib, tivozanib, lenvatinib-based regimens).
• Local practice patterns shaped by guideline adoption, reimbursement rules, and center-level formulary decisions.

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What market dynamics shape Cabometyx demand in mRCC and other oncology settings?

Competition: how Cabometyx stacks up against other mRCC TKIs and IO regimens

mRCC treatment is structurally competitive. Cabometyx competes against:

• Other VEGF-directed TKIs used after or between checkpoint inhibitors (for example axitinib and tivozanib).
• Combination regimens that pair immunotherapy and VEGF inhibitors (where available and where payers cover combinations).

Market share dynamics typically follow:

• Evidence hierarchy by line of therapy and measurable outcomes (OS/response).
• Physician comfort with oral TKIs and toxicity management.
• Payer preference programs that reward preferred brands or require step edits.

Payer and formulary dynamics

Key commercial levers:

• Net price pressure from biosimilar IO and generic VEGF TKIs where applicable.
• Tendering and reference pricing in ex-US markets.
• Prior authorization and step therapy rules for oral oncology TKIs.

Geographic effects

• US typically supports the highest unit economics but is also exposed to faster price erosion where exclusivity ends for comparable competitors.
• EU and other regions are more sensitive to launch timing, reimbursement approvals, and price negotiations.

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What is the financial trajectory for Cabometyx: revenue growth, margins, and trend drivers?

Cabometyx’s financial trajectory is best described as a multi-year S-curve story driven by label growth and uptake, followed by plateau/pressure phases driven by competition and net price erosion.

Revenue trajectory drivers

1. Label expansion and treatment-line penetration
   • New approvals that widen the eligible patient pool increase addressable revenue.
2. Payer adoption
   • Contracts with large payers can accelerate coverage, while unfavorable reimbursement increases delays.
3. Competition and sequencing shifts
   • When newer TKIs or combination strategies gain guideline or payer traction, Cabometyx can face share loss.
4. Ongoing real-world utilization
   • Real-world dosing patterns affect P&L via wastage, dose reductions, and adherence.

Margin and cost structure

Cabometyx is an oncology brand with:

• High cost-to-serve for specialty channels.
• Manufacturing and supply chain obligations for oral oncolytics.
• Ongoing R&D spend supporting new line expansions and new trial readouts.

What to monitor for near-term revenue inflections

• Changes in US and EU prescribing rates versus alternative TKIs.
• Net price changes from contracting.
• Reimbursement coverage shifts tied to adverse event profiles, dose interruptions, and patient management.

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When does Cabometyx lose exclusivity, and what are the generic entry risks?

Cabometyx generic risk is assessed through two layers:

1. Regulatory exclusivity (new chemical entity and/or other exclusivity periods tied to FDA approvals)
2. Patent estate (Orange Book-listed patents and unexpired claims)

Why exclusivity timing matters to revenue

Generic entry typically triggers:

• Rapid share erosion through wholesale and specialty pharmacy switching.
• Net price declines due to competitive bids, rebate changes, and channel pressure.

How to map exclusivity to revenue risk windows

Use a risk window approach:

• Pre-expiration anticipation: settlement or “at-risk” marketing rumors can shift payer behavior early.
• Filing-to-launch lag: ANDA filing timing can foreshadow launch.
• Launch readiness: manufacturing scale-up and distribution agreements drive how fast pricing resets.

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What patents protect Cabometyx, and how strong is the patent estate?

How the patent estate is typically structured

Cabometyx’s IP umbrella generally includes:

• Composition of matter patents (active ingredient and/or salt forms).
• Formulation patents (tablet composition, polymorphs, delivery characteristics).
• Method-of-use patents (indications, specific dosing regimens, line-of-therapy claims).
• Process/manufacturing patents (production routes, intermediates).

Featured snippet answer

Cabometyx’s patent strength is evaluated by the presence of:

• Multiple Orange Book-listed unexpired patents by jurisdiction.
• Additional continuation claims that extend coverage.
• Active litigation or prosecution that narrows generic entry pathways.

How to assess “strength” beyond expiration dates

• Number of concurrently expiring patents (clustering reduces generic leverage).
• Claim scope overlap with generic proposed labeling.
• Likely outcomes in Paragraph IV disputes based on claim construction history.

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What Paragraph IV challenges and FDA Orange Book status affect Cabometyx generics?

Orange Book status: what it indicates

Orange Book listings show:

• Which patents are listed for the approved drug product.
• Whether patents are tied to specific dosage forms or use codes.

Paragraph IV impact

A Paragraph IV notice signals:

• A generic company believes patents are invalid, unenforceable, or not infringed.
• Potential for 180-day exclusivity for the first-filer.
• Litigation-driven stay periods that can shift actual launch dates.

Commercial implication

Even when patents remain, perceived launch probability affects:

• Payer formularies (pre-emptive preferencing of likely entrants).
• Inventory decisions by wholesalers.
• Contract renegotiations with the brand.

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What Cabometyx patent litigation affects time-to-generic and settlement outcomes?

Patent litigation can determine:

• Whether a generic launch is blocked by injunctions or stays.
• Whether settlements enable “design-around” entry dates.
• Whether a generic launches “at risk” before final resolution.

How to interpret settlement-driven market changes

When settlements occur, brand revenue impact often includes:

• Delayed launch from the settlement end date.
• A negotiated entry market share allocation through agreed launch timelines and labeling carve-outs.
• A faster payer transition to competitor products than the generic’s FDA launch date might suggest.

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What formulation patents and dosing/regimen claims can block generic tablets or label substitutes?

Formulation barriers

Formulation patents can slow generic:

• If claim scope covers specific excipients, manufacturing parameters, or stability profiles.
• If polymorph or particle-size distributions are claimed.
• If bioequivalence is affected by formulation differences.

Method-of-use barriers

Method-of-use claims block:

• Generics that must label around patented indications.
• Substitutions that would still infringe under a “carve-out” label strategy.

Dose and regimen claims

• If patents claim specific dosing schedules, generic labeling must avoid those instructions.
• Real-world substitution practices can still create indirect exposure risk if physicians prescribe patented regimens.

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Is biosimilar risk relevant for Cabometyx?

Cabometyx is a small molecule TKI, not a biologic. Biosimilar frameworks do not apply in the standard sense.

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How does Cabometyx compare with competing therapies: market share risks by line of therapy?

Comparison set for mRCC

• Other oral VEGF TKIs (axitinib, tivozanib).
• Combination regimens with immunotherapy and VEGF inhibitors.
• Sequencing alternatives after first-line checkpoint inhibitor strategies.

Decision points that shift prescribing

• Toxicity profiles and manageability (hand-foot syndrome, diarrhea, hypertension, thrombosis risk).
• Clinician preferences for adverse event profiles that align with patient comorbidities.
• Payer access rules tied to documentation of prior therapy.

Net revenue exposure from share loss

Cabometyx revenue is sensitive to incremental share changes because:

• Oncology brands face steep net-to-gross compression when competitors gain formulary placement.
• Oral TKI adherence patterns affect realized demand versus trial populations.

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What are the FDA regulatory milestones and label status that shape Cabometyx uptake?

FDA label breadth affects:

• Eligible patient populations.
• Clinical guidelines inclusion.
• Payer reimbursement approvals tied to specific indications.

How label status translates into uptake

• Broader label indications reduce restriction barriers.
• Earlier-line approval increases patient pool and can lift average yearly treatment counts.

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Where do generics and new entrants face manufacturing and IP barriers for Cabometyx?

Generic feasibility depends on:

• Formulation and process claims.
• Patent scope that covers specific dosage forms.
• Whether generics can seek label carve-outs without losing meaningful commercial value.

Practical barriers

• Bioequivalence challenges tied to formulation differences.
• Litigation risk affecting financing and launch planning.
• Distribution channel commitments with limited upside if label carve-outs restrict use.

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Key financial and market milestones to track for Cabometyx (timeline)

[No source-cited dates were provided in the prompt; timelines below are structural placeholders.]

Timeline phase	What to watch	Revenue impact signal
Current year	Formulary wins/losses, contracting, net price trends	Net-to-gross compression or rebound
Pre-expiration	Generic ANDA filings, Paragraph IV notices	Payer pre-emptive shifting
Litigation window	Claim construction rulings, settlement announcements	Launch delays or accelerated competitive pressure
Launch readiness	Stability of pricing in specialty channels	Immediate share erosion upon launch
Post-launch	Channel switching and rebate renegotiation	Sustained revenue decline trajectory

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Key takeaways

• Cabometyx demand is driven mainly by mRCC sequencing and label breadth, with payer contracting and competitive TKI selection shaping net sales more than headline list price.
• Revenue trajectory is influenced by patent/exclusivity timing and whether Paragraph IV challenges trigger earlier competitive entry dynamics.
• The highest commercial risk is share erosion from new or preferred mRCC standards plus net price pressure tied to contracting once perceived generic/competition timelines tighten.
• IP risk is typically concentrated in composition, formulation, and method-of-use claims; settlements and FDA Orange Book-driven litigation outcomes dictate whether generic launches are delayed or effectively enabled.

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FAQs

1. How do Paragraph IV ANDA challenges typically affect Cabometyx net price before any generic launches?
2. What parts of Cabometyx’s patent estate most often delay generic entry: composition, formulation, or method-of-use claims?
3. Does Cabometyx face meaningful competitive pressure from combination immunotherapy-VEGF regimens, or mainly from other TKIs?
4. How can payer prior authorization criteria change Cabometyx utilization in second-line mRCC?
5. What real-world dosing and adherence factors most influence Cabometyx revenue versus clinical trial persistence?

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. FDA Drug Approval Reports and label information for Cabometyx (cabozantinib). FDA.
3. U.S. FDA. Regulatory information on exclusivity and ANDA/PARAGAPH IV frameworks. FDA.
4. Company filings (public annual reports and quarterly earnings materials for Cabometyx marketer, Ipsen, and any relevant co-development or distribution partners).

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