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 eight patents protecting this drug.

The generic ingredient in COMETRIQ 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 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

US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	55
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 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
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes			Y

Expired US Patents for COMETRIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012

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
Australia	2016262732

Supplementary Protection Certificates for COMETRIQ

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
2213661	C20140029 00117	Estonia		PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014

COMETRIQ Market Dynamics, Patent Estate, Exclusivity and Financial Trajectory

Last updated: September 24, 2026

COMETRIQ is Exelixis Inc.’s capsule formulation of cabozantinib for progressive or metastatic medullary thyroid cancer (MTC). Its commercial value has declined as the broader cabozantinib franchise shifted toward CABOMETYX, the tablet formulation approved for renal cell carcinoma, hepatocellular carcinoma and differentiated thyroid cancer. COMETRIQ remains commercially protected by formulation and composition-of-matter patents, but its market is narrow, competition has intensified, and Exelixis does not separately disclose material COMETRIQ revenue in its public financial reporting.

What is COMETRIQ and how large is its market?

COMETRIQ contains cabozantinib, a multikinase inhibitor targeting MET, VEGFR2, AXL, RET and other kinases. The FDA approved COMETRIQ in November 2012 for patients with progressive metastatic medullary thyroid cancer.[1]

The approved starting dose is 140 mg orally once daily. Dose reductions to 100 mg and 60 mg are permitted to manage adverse events. Common toxicities include diarrhea, palmar-plantar erythrodysesthesia, weight loss, decreased appetite, nausea, fatigue and hypertension.[1]

The commercial market is limited for four reasons:

1. MTC is a rare thyroid cancer.
2. COMETRIQ is generally used in advanced disease after progression or when local treatment is unsuitable.
3. The capsule formulation is less commercially important than CABOMETYX.
4. Selective RET inhibitors provide targeted alternatives for patients with RET-altered disease.

The principal competitive products are:

Product	Active ingredient	Company	Relevant setting	Competitive effect
COMETRIQ	Cabozantinib capsules	Exelixis	Progressive metastatic MTC	Original cabozantinib product
CAPRELSA	Vandetanib	Sanofi	Symptomatic or progressive MTC	Established multikinase competitor
RETEVMO	Selpercatinib	Eli Lilly	RET-mutated advanced MTC	Targeted alternative with strong biomarker positioning
GAVRETO	Pralsetinib	Rigel, formerly Blueprint	RET-altered thyroid cancer	Additional RET-directed option, with commercial restructuring
CABOMETYX	Cabozantinib tablets	Exelixis	RCC, HCC and differentiated thyroid cancer	Larger cabozantinib franchise; not interchangeable with COMETRIQ

RETEVMO has changed treatment sequencing in RET-driven MTC because it is designed specifically for RET-altered tumors. COMETRIQ retains relevance where RET-directed therapy is unsuitable, unavailable, not tolerated or no longer effective.

When does COMETRIQ lose exclusivity?

COMETRIQ’s regulatory exclusivity expired years ago, while patent protection extends beyond the original FDA exclusivity periods.

Protection type	Milestone	Status
FDA approval	November 29, 2012	Active product approval
New chemical entity exclusivity	Approximately November 2017	Expired
Orphan-drug exclusivity	Approximately November 2019	Expired
Core cabozantinib patent protection	Mid-2020s, subject to patent-specific terms	Relevant to generic entry
Later formulation or use patents	Potentially later dates	Scope and enforceability depend on claim coverage

The five-year new chemical entity period expired in 2017. The seven-year orphan-drug exclusivity period expired in 2019. Those protections prevent certain FDA approvals during the statutory periods but do not themselves determine current generic entry.

The practical exclusivity question is now patent-driven. A generic applicant may file an Abbreviated New Drug Application with a Paragraph IV certification challenging listed patents before all listed patents expire. The outcome would depend on the patents certified, the timing of litigation, and whether any settlement permits an earlier launch.

What patents protect COMETRIQ?

The COMETRIQ patent estate includes patents covering cabozantinib compounds, pharmaceutical compositions, salt forms and therapeutic uses. Public FDA Orange Book data should be used for the current listed-patent record because listing status and expiration dates can change through corrections, pediatric extensions or patent-term adjustments.[2]

The central patent categories are:

Composition-of-matter patents

Composition patents provide the strongest protection because they can cover the active molecule rather than a particular indication or dosage form. Cabozantinib’s early patent family includes U.S. Patent No. 7,579,473, which is associated with kinase-inhibitor compounds and has a listed expiration in the mid-2020s, subject to applicable adjustments and extensions.

A successful challenge to a valid composition patent would materially reduce the barrier to generic cabozantinib. A later-entry generic could still face separate formulation or method-of-use patents, but those protections are usually narrower.

Formulation and salt patents

COMETRIQ is a capsule formulation, while CABOMETYX is a tablet formulation. The products are not automatically substitutable because they have different dosage forms, strengths, excipients and labeled uses.

Formulation patents can protect:

• Specific cabozantinib salt forms.
• Capsule compositions.
• Tablet compositions.
• Stability characteristics.
• Manufacturing processes.
• Dissolution or bioavailability profiles.

Formulation patents can delay an exact generic product but may not prevent a non-infringing alternative formulation if the active-ingredient patent has expired.

Method-of-use patents

Method patents may cover cabozantinib treatment of specific cancers, patient populations, dosing regimens or combinations. Their commercial value is lower when physicians can prescribe a generic product for an unpatented use and the generic label omits the protected indication.

For COMETRIQ, method-of-use protection is less powerful than composition protection because MTC is a narrow indication and cabozantinib’s broader commercial value lies in CABOMETYX indications.

What is the Orange Book status of COMETRIQ?

COMETRIQ is an FDA-approved small-molecule drug listed in the Orange Book. The Orange Book identifies approved products, therapeutic-equivalence information and patents submitted by the NDA holder.[2]

The relevant legal points are:

• COMETRIQ is not a biologic and therefore is not subject to the biosimilar pathway.
• A generic applicant would generally use the ANDA pathway.
• Paragraph IV certifications can trigger patent litigation.
• An ANDA approval does not automatically establish commercial entry if an injunction, settlement or regulatory exclusivity remains in effect.
• The capsule formulation and labeled MTC indication may create a narrower generic target than cabozantinib tablets used in other cancers.

Public regulatory records do not establish a current FDA-approved generic COMETRIQ launch. Patent litigation and settlement terms must be reviewed against current court dockets and Orange Book updates because a future generic filing can change the risk profile quickly.

Which companies challenge COMETRIQ exclusivity?

The most likely challengers are generic manufacturers with oncology distribution and controlled-substance-free oral oncology infrastructure. Potential entrants would evaluate:

• The remaining composition patent term.
• Whether a Paragraph IV challenge can invalidate or narrow the core patent.
• Whether the capsule formulation can be designed around.
• The commercial return from a small MTC-only market.
• Whether a generic applicant can obtain a label that avoids patented uses.
• Manufacturing complexity, including active-pharmaceutical-ingredient supply and low-volume capsule production.

Unlike high-volume drugs, COMETRIQ may not attract many generic filers because the addressable market is small and the product requires oncology-focused distribution. A first filer could still obtain substantial commercial value if it secures 180-day generic exclusivity, but that value is constrained by the size of the MTC market.

What patent litigation affects COMETIQ generic entry?

The principal litigation risk is an ANDA patent case involving the listed cabozantinib patents. Under the Hatch-Waxman framework, Exelixis could sue after receiving a Paragraph IV notice, generally triggering a 30-month stay of ANDA approval unless the case is resolved earlier.[3]

The most important litigation scenarios are:

Scenario	Commercial effect
Core composition patent upheld	Generic entry delayed until expiry or settlement date
Core patent invalidated	Accelerated generic launch risk
Formulation patent upheld but composition patent expires	Possible non-infringing generic formulation
Method patent only	Label carve-out may permit partial generic entry
Settlement with licensed launch date	Predictable but potentially earlier entry
No viable ANDA challenge	Continued branded pricing, although demand remains limited

No widely reported settlement should be treated as dispositive without checking the current court docket, FDA Orange Book and Exelixis SEC filings. Patent expiry dates alone do not prove that generic entry will occur on the following day.

How does COMETRIQ compare with CABOMETYX?

CABOMETYX is the economically dominant cabozantinib product. The products share the same active ingredient but address different commercial markets.

Attribute	COMETRIQ	CABOMETYX
Dosage form	Capsule	Tablet
Initial FDA indication	Progressive metastatic MTC	RCC
Key later indications	MTC market	RCC, HCC and differentiated thyroid cancer
Commercial market	Narrow	Broad specialty-oncology market
Main competitors	RETEVMO, CAPRELSA	Opdivo combinations, Lenvima, Stivarga and others
Strategic role	Legacy and niche product	Core Exelixis growth asset

The distinction matters in patent analysis. A generic COMETRIQ launch would not necessarily create automatic substitution for CABOMETYX. A challenger would need to obtain approval for the relevant dosage form, strength and indications. Exelixis can also maintain separate patent strategies for tablet formulations and later oncology uses.

What is COMETRIQ’s financial trajectory?

Exelixis has shifted its financial center of gravity from COMETRIQ to CABOMETYX. The company’s public filings report total product revenue and emphasize CABOMETYX as the primary commercial driver. COMETRIQ is not presented as a major separately reported revenue segment in the company’s recent annual reporting.[4]

The financial trajectory has four phases:

2012 to 2016: launch and initial expansion

COMETRIQ entered the market as a treatment for advanced MTC. Revenue was supported by orphan-drug pricing and the absence of RET-selective competitors.

2017 to 2019: franchise diversification

Cabozantinib gained additional value through CABOMETYX approvals in renal cell carcinoma and later liver cancer. Exelixis began relying on the tablet product for larger markets.

2020 to 2023: COMETRIQ becomes a niche asset

RET-directed products entered the MTC market. CABOMETYX generated the overwhelming majority of cabozantinib franchise value, while COMETRIQ remained a smaller legacy product.

2024 onward: patent and portfolio management

COMETRIQ’s value is primarily defensive and incremental. The asset can generate cash flow while patents remain enforceable, but long-term growth depends on CABOMETYX indications, lifecycle management and international partnerships rather than MTC volume expansion.

Exelixis reported 2023 total revenue of approximately $1.83 billion, with product revenue dominated by CABOMETYX and collaboration revenue from its global partners.[4] The company’s financial disclosures do not support treating COMETRIQ as an independent growth platform.

What licensing deals affect COMETRIQ?

Exelixis has used regional licensing arrangements for cabozantinib. Ipsen obtained commercial rights in territories outside the United States, Canada and Japan under a 2016 agreement. Takeda has held Japanese rights under a separate arrangement.[5][6]

These agreements affect:

• Regional commercialization.
• Royalty and milestone economics.
• Local regulatory approvals.
• Geographic patent enforcement.
• The distribution of generic-entry risk.

The United States remains the key market for direct Exelixis control over COMETRIQ. Outside the United States, local launch timing depends on regional approvals, patent status, license terms and partner strategy.

How strong is the COMETRIQ patent estate?

The estate is moderate to strong in the near term but weaker as a long-term growth barrier.

Strengths include:

• A historically important composition-of-matter patent.
• FDA-approved orphan oncology status.
• A regulated capsule product with specialized distribution.
• Limited incentive for generic companies to pursue a small market.
• Separate cabozantinib formulations and indications across the franchise.

Weaknesses include:

• Expired FDA exclusivity.
• Narrow MTC patient population.
• RET-directed competition.
• Expected pressure as core patents approach expiration.
• Potential design-around options for formulation claims.
• Limited incremental revenue available from price increases or broader penetration.

The most important variable is whether the core cabozantinib patent survives challenge through its effective expiration date. Secondary formulation and method patents can extend friction but are less likely to preserve broad market exclusivity by themselves.

What generic launch scenarios exist for COMETRIQ?

Earliest-entry scenario

A Paragraph IV challenger invalidates or avoids the key composition patent and receives FDA approval before the expected expiry date. This would create rapid price erosion and could reduce Exelixis’ U.S. COMETRIQ revenue substantially.

Settlement scenario

Exelixis settles with a generic applicant and grants a license for an agreed launch date. The settlement could preserve branded revenue until the licensed date while eliminating litigation costs.

Delayed-entry scenario

The core patent is upheld, and no generic enters until expiry. COMETRIQ continues producing niche revenue, but demand remains constrained by RETEVMO and other alternatives.

Limited-use generic scenario

A generic launches with a restricted label that excludes patented indications. In MTC, the commercial value of a carve-out may be limited because the product’s principal approved use is itself the relevant market.

What is the FDA regulatory status of COMETRIQ?

COMETRIQ remains FDA-approved for progressive metastatic MTC. It is not a biologic, does not qualify for biosimilar competition and is regulated as a small-molecule oncology drug. Any generic entrant would generally need to demonstrate pharmaceutical equivalence and bioequivalence through an ANDA rather than repeat the full clinical development program.[1][3]

The regulatory status is stable, but the product’s commercial relevance is declining relative to CABOMETYX and RET-selective therapies.

Key Takeaways

• COMETRIQ is cabozantinib capsules for progressive metastatic MTC.
• FDA new chemical entity exclusivity expired around 2017; orphan-drug exclusivity expired around 2019.
• Patent protection, rather than regulatory exclusivity, controls near-term generic-entry risk.
• U.S. Patent No. 7,579,473 is a central cabozantinib composition patent associated with mid-2020s protection, subject to current Orange Book terms and adjustments.
• RETEVMO and other RET-directed therapies have reduced COMETRIQ’s growth potential.
• CABOMETYX is the economically important cabozantinib product for Exelixis.
• Exelixis does not separately disclose COMETRIQ as a material standalone revenue contributor in recent public filings.
• The most credible generic risks are a Paragraph IV challenge, a formulation design-around or a negotiated settlement.
• COMETRIQ is not exposed to biosimilar competition because it is a small-molecule drug.
• The asset’s value is now primarily defensive cash flow, patent preservation and franchise support.

FAQs About COMETRIQ Patents, Generic Entry and Market Value

Is COMETRIQ the same drug as CABOMETYX?

Both contain cabozantinib, but they are different FDA-approved products with different dosage forms, strengths and labeled indications. COMETRIQ is a capsule for MTC; CABOMETYX is a tablet used in several larger oncology markets.

Can a generic company substitute CABOMETYX for COMETRIQ?

No. Automatic substitution depends on FDA therapeutic-equivalence determinations and the specific approved product. A generic CABOMETYX tablet would not automatically substitute for COMETRIQ capsules.

Does COMETRIQ have biosimilar risk?

No. Biosimilars apply to biological products. COMETRIQ is a small-molecule drug and faces conventional generic, not biosimilar, competition.

Which drug has the strongest competitive position in RET-mutated MTC?

RETEVMO has the clearest biomarker-specific positioning for RET-altered MTC. COMETRIQ remains relevant for patients who are not candidates for RET-selective treatment or who require another line of therapy.

What would most reduce COMETRIQ’s commercial value?

The largest risks are invalidation or expiration of the core cabozantinib patent, a successful Paragraph IV challenge, and continued displacement by RET-selective therapies. A generic launch would likely cause faster price erosion than additional branded competition.

References

1. U.S. Food and Drug Administration. (2023). Cometriq (cabozantinib) capsules prescribing information. FDA.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355(j).

4. Exelixis, Inc. (2024). Annual report for the fiscal year ended December 31, 2023, Form 10-K. U.S. Securities and Exchange Commission.

5. Ipsen. (2016). Ipsen and Exelixis enter into exclusive licensing agreement for cabozantinib outside the United States. Ipsen corporate release.

6. Takeda Pharmaceutical Company Limited. (2017). Takeda and Exelixis announce Japanese development and commercialization collaboration for cabozantinib. Takeda corporate release.