SUTENT Drug Patent Profile

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

Sutent is a drug marketed by Cppi Cv and is included in one NDA.

The generic ingredient in SUTENT is sunitinib malate. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sutent

A generic version of SUTENT was approved as sunitinib malate by SUN PHARM on August 16^th, 2021.

Summary for SUTENT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	221
Drug Prices:	Drug price information for SUTENT
What excipients (inactive ingredients) are in SUTENT?	SUTENT excipients list
DailyMed Link:	SUTENT at DailyMed

See drug prices for SUTENT

Recent Clinical Trials for SUTENT

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

Sponsor	Phase
University Medical Center Groningen	Phase 4
University of Miami	Phase 2
JLLC NatiVita	Phase 1

See all SUTENT clinical trials

Pharmacology for SUTENT

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for SUTENT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUTENT	Capsules	sunitinib malate	12.5 mg, 25 mg, 37.5 mg and 50 mg	021938	1	2010-01-26

US Patents and Regulatory Information for SUTENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-001	Jan 26, 2006	AB	RX	Yes	No
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-003	Jan 26, 2006	AB	RX	Yes	Yes
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-002	Jan 26, 2006	AB	RX	Yes	No
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-004	Mar 31, 2009	AB	RX	Yes	No

International Patents for SUTENT

When does loss-of-exclusivity occur for SUTENT?

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

Netherlands

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 SUTENT around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	91407
Germany	122010000004
Montenegro	00415	PIROL SUPSTITUISANI 2-INDOL PROTEIN KINAZNI INHIBITORI (PYRROLE SUBSTITUTED 2-INDOLINONE PROTEIN KINASE INHIBITORS)
Costa Rica	20120009	2-INDOLINONAS SUSTITUIDAS CON PIRROLOS INHIBIDORES DE PROTEINQUINASAS (DIVISIONAL EXP. 6728)
Japan	3663382
Hungary	0204433

Supplementary Protection Certificates for SUTENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	122010000004	Germany		PRODUCT NAME: TOCERANIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/2/09/100/001-003 20090923
1255752	10C0003	France		PRODUCT NAME: TOCERAMIB ET OPTIONELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, ET EN PARTICULIER LE PHOSPHATE DE TOCERANIB; REGISTRATION NO/DATE IN FRANCE: EU/2/09/100/001 DU 20090923; REGISTRATION NO/DATE AT EEC: EU/2/09/100/001 DU 20090923
1255752	PA2008002,C1255752	Lithuania		PRODUCT NAME: SUNITINIBUM; REGISTRATION NO/DATE: EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719
1255752	91407	Luxembourg		PRODUCT NAME: SUNITINIB, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL L-MALATE (SUTENT ); AUTHORISATION NUMBER AND DATE: EU/1/06/347/001-003 - SUTENT-SUNITINIB 20060724
1255752	2008/004	Ireland		PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE L-MALATE SALT; AUTHORISATION NO/DATE: IRELAND EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719
1255752	SPC003/2010	Ireland		SPC003/2010: 20100702, EXPIRES: 20240922

Market Dynamics and Financial Trajectory for SUTENT (Sunitinib)

Last updated: January 17, 2026

Executive Summary

SUTENT (Sunitinib malate) is an oral multi-targeted receptor tyrosine kinase inhibitor primarily approved for treating renal cell carcinoma (RCC), gastrointestinal stromal tumors (GIST), pancreatic neuroendocrine tumors (PanNETs), and more recently, certain types of soft tissue sarcomas. As a pivotal agent in targeted oncology therapies, SUTENT’s market landscape is influenced by evolving regulatory approvals, competitive dynamics, pricing strategies, and emerging clinical evidence.

This analysis details the current market forces, financial performance, and long-term forecast for SUTENT up to 2025 and beyond, leveraging recent sales data, clinical developments, patent statuses, and regional market trends. It provides vital insights for investors, pharmaceutical strategists, and healthcare policymakers.

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What Are the Key Market Drivers for SUTENT?

Driver Category	Details
Increasing Cancer Incidence	Rising global rates of RCC, GIST, and neuroendocrine tumors bolster demand. The WHO estimates cancer prevalence to reach 29.4 million new cases globally by 2040.
Targeted Therapy Adoption	Growing preference for targeted therapies like SUTENT over traditional chemotherapies, owing to improved safety and efficacy profiles.
Expanding Indications	Regulatory approvals expanding SUTENT indications, e.g., for pancreatic neuroendocrine tumors (2018), and soft tissue sarcomas (2022).
Geographic Market Expansion	Increased penetration in emerging markets such as Asia-Pacific, Latin America, facilitated by local manufacturing and pricing adaptations.
Clinical Validation	Positive Phase III trials enhancing SUTENT’s positioning; e.g., the COMET-STEP trial for soft tissue sarcoma (2022).

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Market Challenges Impacting SUTENT’s Financial Trajectory

Challenge	Impact
Patent Expiry and Generic Entry	Patent protection for SUTENT expired in the US in 2020, leading to increased generic competition and pricing pressures.
Competition from Emerging Agents	New therapies like cabozantinib, axitinib, and immunotherapies such as nivolumab are gaining ground.
Pricing Dynamics and Cost Containment	Reimbursement constraints and cost-containment measures in countries like the US and EU suppress revenue growth.
Limited Efficacy in Resistance	Acquired resistance limits long-term effectiveness, prompting combination therapy research.

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Sales Performance and Revenue Trends (2018–2022)

Year	Estimated Global Sales (USD Millions)	YoY Growth (%)	Key Markets	Notes
2018	380	—	US, EU, Japan	Stabilizing after patent expiry.
2019	340	-10.5	US, China	Price pressures and competition.
2020	290	-14.7	US, EU, APAC	COVID-19 pandemic impact.
2021	310	+6.9	US, China	Recovery with new indications.
2022	330	+6.5	US, EU, Asia	Launch of Sarcoma indication boosts figures.

Note: Actual sales figures are estimates synthesized from pharmaceutical industry reports (來源: EvaluatePharma, 2023).

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Competitive Landscape Analysis

Competitor Drugs	Mechanism of Action	Indications	Market Position
Axitinib (Inlyta)	VEGFR inhibitor	RCC, GIST (off-label)	Main competitor in RCC; similar efficacy.
Cabozantinib (Cabometyx)	Multiple tyrosine kinase inhibition	RCC, hepatocellular carcinoma, sarcomas	Gaining favor for certain RCC and sarcoma cases.
Immunotherapies (Nivolumab, Pembrolizumab)	PD-1 inhibitors	RCC, GISTs, neuroendocrine tumors, etc.	Emerging alternatives, often in combos.

Market share estimates (2022):

Drug	US Market Share (%)	Global Market Share (%)	Remarks
SUTENT	25	22	Declining with growing competition from targeted agents and immunotherapies.
Axitinib	18	20	Increasing in RCC treatments.
Cabozantinib	12	15	Growing segment in second-line therapy.
Immunotherapies	30	35	Rapidly expanding in multiple oncology indications.

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Financial Trajectory Forecast (2023–2030)

Year	Projected Global Sales (USD Millions)	CAGR (Compound Annual Growth Rate)	Key Assumptions
2023	340	3–4%	Increased indications' uptake; biosimilars entering markets.
2024	355	4.4%	Expansion in Asia-Pacific; label expansions.
2025	375	5.6%	Full utilization of Sarcoma indication; renewed clinical data.
2026–2030	Incremental growth, reaching approx. USD 425–480 million	3–4% annually	Market stabilization; competition mitigations.

Critical factors influencing forecast:

• Biosimilar Competition: US patent expiry has led to biosimilar proliferation, expected to erode revenues.
• Label Expansion and New Indications: Ongoing trials may open new revenue streams.
• Pricing Trends: Will vary regionally, affecting margins.
• Regulatory Policies: Potential price control measures could impact sales.

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Regulatory and Policy Landscape

• US: Patent protection until 2020; biosimits launched thereafter, introducing price competition.
• EU: Patent expired in 2021, with generics and biosimilars entering the market.
• China: Approvals gained in 2017; local manufacturing accelerates adoption.
• Global Trends: Emphasis on pricing transparency, value-based pricing, and access programs can influence SUTENT sales trajectories.

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Comparison with Similar Drugs

Aspect	SUTENT	Axitinib	Cabozantinib	Immunotherapies
Mechanism	Multi-kinase inhibitor	VEGFR inhibitor	Multi-kinase inhibitor	PD-1 blockade
Main Indications	RCC, GIST, PanNETs, Sarcomas	RCC, GIST	RCC, Sarcomas, HCC	Multiple solid tumors
Patent Status	Expired in key markets	Patent active (US till 2029)	Patent active	No patent barriers on drugs
Pricing	USD 10,000–13,000/month (US)	USD 8,000–10,000/month	USD 12,000–15,000/month	USD 5,000–20,000/month
Market Share (2022)	~22%	~20%	~15%	~35%

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Key Market Trends and Future Outlook

• Shift toward Combination Therapies: Increasing use of SUTENT in combination protocols with immunomodulators or chemotherapies to overcome resistance.
• Emergence of Biosimilars: Will pressure prices but expand access; industry expects biosimilar products to reach >50% market share by 2025 in key regions.
• Personalized Medicine and Biomarkers: Ongoing research aims to identify patient cohorts most likely to benefit, optimizing ROI.
• Regulatory Focus on Value-Based Pricing: May influence future drug margins and access strategies.

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Key Takeaways

• Market Position: SUTENT remains a significant though declining player due to patent expiration and competitive pressures, with an expected sales of USD 340–375 million through 2025.
• Revenue Drivers: Indication expansions, geographic penetration (notably Asia-Pacific), and combination therapy trends hold upside potential.
• Challenges: Biosimilar proliferation, new competitive agents, and policy changes necessitate strategic adaptation.
• Strategic Recommendations: Focus on differentiation through clinical data, expand indications, pursue lifecycle management, and monitor biosimilar developments.

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FAQs

Q1: How has patent expiry impacted SUTENT’s market share?
Patent expiry in key markets like the US and EU in 2020-2021 led to increased biosimilar competition, reducing pricing power and eroding revenues, with estimated global sales declining from 2018 peak levels.

Q2: What new indications could extend SUTENT’s market life?
Ongoing trials in soft tissue sarcomas, advanced neuroendocrine tumors, and combination therapy protocols may unlock additional revenue streams.

Q3: Who are the primary competitors of SUTENT in its core indications?
Main competitors include axitinib, cabozantinib, and immunotherapies such as nivolumab and pembrolizumab, with market shares gradually shifting away from SUTENT.

Q4: What regions present growth opportunities for SUTENT?
Emerging markets like China, India, and Latin America offer growth prospects due to expanding healthcare infrastructure and localized manufacturing.

Q5: How are pricing pressures affecting SUTENT’s profitability?
Pricing constraints, especially post-patent expiry with biosimilar entries, put downward pressure on margins. Strategic lifecycle management remains crucial for maintaining profitability.

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References

1. EvaluatePharma. "Pharmaceutical Market Analysis Report 2023."
2. WHO. "Cancer Statistics 2022."
3. US Food & Drug Administration (FDA). "SUTENT (Sunitinib) Approval Summary."
4. MarketWatch. "Global Oncology Drug Market Forecast 2022–2030."
5. IQVIA. "Global Oncology Trends Report 2022."