COMETRIQ Drug Patent Profile

When do Cometriq patents expire, and what generic alternatives are available?

Cometriq is a drug marketed by Exelixis and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and ninety 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 January 15, 2030. This may change due to patent challenges or generic licensing.

There have been eighteen 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:	190
US Patents:	8
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMETRIQ

US Patents and Regulatory Information for COMETRIQ

COMETRIQ is protected by eight 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	Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			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

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 COMETRIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	075025
Australia	2010204619
Australia	2013203780

Supplementary Protection Certificates for COMETRIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	SPC/GB14/052	United Kingdom		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/13/890/001-006 20140326
2213661	132014902289810	Italy		PRODUCT NAME: CABOZANTINIB(COMETRIQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/890/001,002,003, 20140326
2213661	CR 2014 00039	Denmark		PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326

COMETRIQ (cabozantinib): Investment scenario and fundamentals analysis for the pharmaceutical drug

Last updated: July 26, 2026

Executive summary: COMETRIQ (cabozantinib) is an established oncology asset with meaningful remaining commercial utility, but the investment case is driven by (1) residual patent and exclusivity headwinds for branded supply, (2) ongoing competitive pressure from other VEGFR/RET TKIs and sequencing standards, and (3) the ability to defend or monetize differentiated labeling, formulations, and regional rights through a tightening generic/biosimilar window. The next phase of upside is less about new mechanism discovery and more about protecting market access and sustaining payer coverage while managing patent litigation and launch timing risk across jurisdictions.

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What is COMETRIQ cabozantinib used for and what market does it serve?

COMETRIQ is a cabozantinib brand used in oncology under FDA-approved indications for RET-driven and advanced thyroid cancers, positioned around RET inhibition with multi-kinase activity (VEGFR2/VEGFR3, MET, AXL and others). It sits in the wider treatment landscape for differentiated thyroid cancer with RET alterations and for medullary thyroid cancer (MTC).

Which indications drive revenue exposure

• Medullary thyroid cancer (MTC)
• RET-mutant advanced/metastatic differentiated thyroid cancer (DTC) in the FDA-labeled context for cabozantinib

How COMETRIQ compares with competing RET/thyroid oncology standards

COMETRIQ competes with:

• Lenvatinib and pazopanib in thyroid cancer treatment ecosystems (disease-state and line-dependent)
• Selpercatinib and pralsetinib for RET-mutant disease depending on indication and sequencing
• Other multi-kinase VEGFR inhibitors depending on payer policies and local standard of care

Investment implication: COMETRIQ’s fundamental value is tied to line placement and payer willingness to fund cabozantinib versus RET-selective competitors, which often win on tolerability and response durability in biomarker-defined settings.

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What is the FDA approval and Orange Book status of COMETRIQ?

COMETRIQ is marketed as an oral oncology therapy with FDA labeling built on clinical efficacy in thyroid cancer populations. Its exclusivity and patent posture are evaluated through:

• FDA approval history and post-marketing labeling changes
• Orange Book patent listings for the branded drug and any granted exclusivities

How to read the Orange Book investment signal

For branded revenue defense, the market impact generally maps to:

• Composition of matter patents (core molecule protection)
• Method-of-use patents (label-related)
• Formulation and dose regimen patents (e.g., dosing schedule, capsule formulation strategy)
• Any pediatric exclusivity or other exclusivity extensions

Investment implication: If Orange Book shows continuing method-of-use or formulation patents that remain enforceable, branded manufacturers can delay generic entry or secure settlements that extend revenues. If listings are thin or litigated early, generics tend to compress price faster.

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When does COMETRIQ lose exclusivity and what patent expiration dates matter most?

The investment timetable is determined by:

1. The end of any statutory exclusivity periods
2. The expiration of key Orange Book-listed patents
3. Patent-by-patent litigation outcomes that trigger earlier generic entry
4. Country-specific exclusivity regimes

What to track for the next generic entry risk window

• Expiration of core cabozantinib molecule patents
• Expiration of specific dosing regimen patents (if listed)
• Expiration and litigation status of method-of-use patents aligned to labeled indications

Investment implication: Generic risk is front-loaded by method-of-use patent challenges if generic manufacturers seek “label carve-outs.” The net effect for investors is a step-down in branded ASP and volume share once full-coverage generics enter.

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What patents protect COMETRIQ (cabozantinib) and how many are in the estate?

COMETRIQ’s protection typically spans multiple patent families that can include:

• Composition of matter for cabozantinib
• Salts, polymorphs, or crystal form claims
• Formulation and manufacturing method claims for oral dosing
• Method-of-use claims for thyroid cancer indications and RET-defined subgroups

How many patents usually drive the risk profile

The practical risk is rarely the raw count of patents, but the subset that:

• is Orange Book-listed
• is enforced or litigated in the U.S.
• blocks generic entry via Paragraph IV or settlement restrictions

Investment implication: A dense estate that is heavily litigated and upheld provides revenue duration. A large estate with weak enforceability or near-expiry improves generic entry odds.

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How strong is the patent estate for COMETRIQ and what is the litigation-driven downside?

What matters for “strength” in an investment model

For COMETRIQ, the estate strength should be judged by:

• Whether key Orange Book patents survive legal scrutiny
• Whether the branded party secured settlements that delay launch
• Whether courts narrow claim scope that allows partial label entry
• Whether generic challengers gain leverage through obviousness or non-infringement findings

Litigation structure that changes revenue outcomes

Common pathways that compress revenue:

• Paragraph IV filings leading to 30-month stays and later launch
• Final invalidation of method-of-use patents, enabling broader label generics
• Settlement agreements that cap at a date, then generic entry occurs immediately at the cap

Investment implication: The steepest downside typically comes when method-of-use exclusivity collapses while composition patents are already near expiry, allowing generics to enter with fewer label carve-outs.

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Which companies are challenging COMETRIQ with Paragraph IV and what does that imply for launch timing?

Paragraph IV challenges are the key measurable leading indicator for:

• Generic launch calendars
• Settlement likelihood
• Payer switching speed post-launch

What to map in an investment scenario

• Challenger identity (U.S. filings are directly tied to Orange Book listings)
• Which patents were challenged (composition vs method-of-use vs formulation)
• Dates of filing, FDA acceptances, and litigation milestones
• Whether a settlement triggered a negotiated launch delay

Investment implication: The earliest challengers tend to set the earliest plausible generic entry date. If the case targets method-of-use patents, the label scope of the generic at launch is critical for revenue recovery.

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What settlement agreements affect COMETRIQ generic entry risk?

Settlements are the bridge between patent litigation and market entry. The primary investment-relevant variables are:

• Effective launch dates
• Scope restrictions (territory, dosage forms, or labeling)
• Payment terms (often not fully disclosed in publicly accessible documents, but can be inferred from timing patterns)
• “Design-around” permissions that allow entry earlier at reduced label coverage

Investment implication: Settlement terms determine whether investors should underwrite revenue durability or model earlier price compression.

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What formulations and dosing regimens are protected for COMETRIQ?

COMETRIQ’s investment relevance extends beyond the API because:

• Oral tyrosine kinase inhibitor formulations affect manufacturing cost and bioavailability
• Dosing regimens and tablet/capsule strength can be the basis for formulation or regimen patents

Key formulation patent categories to track

• Capsule or tablet formulation IP
• Active ingredient particle properties (if claimed)
• Manufacturing method protections (process patents)
• Dosing schedule and regimen claims

Investment implication: Even after composition expiry, formulation and regimen protections can delay full generic switching if label or dosing claims are blocked.

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How does COMETRIQ compare with other cabozantinib brands and competitors in the thyroid cancer market?

Cabozantinib has multi-indication relevance across oncology, but COMETRIQ’s economics are tied to thyroid cancer label. Competitive pressure comes from:

• RET-selective agents (selpercatinib, pralsetinib) with biomarker-defined targeting
• Multi-kinase VEGFR inhibitors where payer policy may prefer lowest-cost options

Competitive positioning levers

• Tolerability management and dose interruption strategies
• Response rates and progression outcomes in labeled populations
• Sequencing evidence and guideline placement in MTC and RET-mutant DTC contexts

Investment implication: If payer behavior shifts toward RET-selective agents in first-line or earlier lines, COMETRIQ volume growth becomes harder even if generic entry does not occur immediately.

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What is the generic entry scenario for COMETRIQ and how fast does revenue typically decline?

Revenue compression mechanics

Post-generic entry, branded performance depends on:

• Portion of patients remaining on branded due to tolerability, clinician preference, or switching inertia
• Pharmacy benefit manager contracts and rebate changes
• Differences in dose accuracy and patient handling of oral TKIs

Modelable scenarios for investors

• Full label generic entry: faster ASP compression, near-linear volume migration over 6 to 18 months
• Label carve-out entry (method-of-use blocked): slower migration; branded retains higher share in indications not covered by generic label
• Settlement-based early entry controls: revenue decline starts at the settlement launch date, not earlier

Investment implication: The highest volatility is around the transition from brand-only to full generic coverage, because payer switching and contract renegotiation accelerate quickly after the first generic launch.

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What FDA regulatory milestones and post-marketing changes matter for COMETRIQ?

Investment tracking should include:

• Label updates that expand or restrict eligible patients
• Changes to dosing guidance that may affect generic design-around strategies
• Safety-related label changes that can influence switchability and utilization management

How regulatory changes affect IP and competition

• Label expansion can sustain method-of-use coverage longer if new claims map to updated indications
• Restriction or narrowing may reduce remaining generic threats by limiting covered patient populations, but also can reduce peak sales potential

Investment implication: Regulatory milestones can shift both commercial upside and legal leverage.

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What is the competitive landscape for RET-mutant and medullary thyroid cancer therapies?

COMETRIQ sits inside a high-evidence, biomarker-driven market where:

• RET mutations correlate with selection pressure toward RET-specific agents
• MTC treatment patterns depend on prior VEGFR/multi-kinase exposure and patient performance status

Investment-relevant competitive axes

• Time-on-therapy and dose manageability
• Real-world adherence and discontinuation rates
• Payer coverage policies for oral oncology agents

Investment implication: COMETRIQ’s commercial resilience depends on clinician preference and payer reimbursement stability, even before generic entry occurs.

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How do manufacturing and IP barriers affect COMETRIQ generic competition?

Oral oncology manufacturing is a capability test, but IP can still be a barrier even when API patents near expiry. Investors should consider:

• Whether a challenger can produce bioequivalent cabozantinib capsule formulations without crossing protected formulation/regimen claims
• Whether process patents have enforceable coverage that slows generic process development
• Whether compendial substitution is blocked by brand-specific requirements

Investment implication: Strong enforceable manufacturing/process IP can slow competition, extending the period before meaningful price compression.

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Country and jurisdiction analysis: where is COMETRIQ most at risk?

Generic entry risk varies by:

• Strength and duration of local patents
• Litigation venue strategy and settlement prevalence
• Local regulatory requirements and reimbursement dynamics

Investment model approach

• Underwrite a base case where U.S. entry drives the global brand price corridor
• Apply higher risk to jurisdictions where U.S. patent outcomes translate quickly through local practice
• Model longer protection in markets with robust patent enforcement or where method-of-use claims are more durable

Investment implication: U.S. is typically the earliest and most liquid signal; it sets expectation for global pricing and contract dynamics.

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Key Takeaways

• COMETRIQ’s investment case is dominated by patent and exclusivity timelines tied to Orange Book-listed protections, especially method-of-use and formulation/régimen claims that gate generic label entry.
• The downside catalyst is early or broad generic entry following Paragraph IV challenges or settlement-triggered launch dates, which can drive rapid ASP and volume compression.
• The upside catalyst is sustained commercial differentiation via labeled use-case strength, payer coverage retention, and any surviving patent scope that limits generic substitutability.
• Competitive pressure from RET-selective TKIs constrains growth even before generic entry, so revenue durability relies on sequencing and reimbursement stability.

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FAQs

1. What drives the fastest generic displacement for COMETRIQ, label scope or price?
2. How do method-of-use patent outcomes for COMETRIQ affect whether generics can launch with full indication coverage?
3. What settlement structures most often extend branded COMETRIQ revenues, and how can investors detect them from case timelines?
4. How do safety or dose guidance label updates influence generic switching behavior for oral TKIs like cabozantinib?
5. Which competitive therapies most directly compete with COMETRIQ in RET-mutant differentiated thyroid cancer and medullary thyroid cancer?

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References

1. FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. FDA.
2. U.S. Food and Drug Administration. Drug approval and labeling information for COMETRIQ (cabozantinib).
3. FDA. Drug patent and exclusivity information (Hatch-Waxman exclusivity resources).