sutent Drug Patent Profile

Which patents cover Sutent, and when can generic versions of Sutent launch?

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
Norway	325532
Norway	2010002
Australia	3436301
China	1329390

Supplementary Protection Certificates for sutent

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	SPC003/2010	Ireland		SPC003/2010: 20100702, EXPIRES: 20240922
1255752	312	Finland
1255752	C200800007	Spain		PRODUCT NAME: SUNITINIB; NATIONAL AUTHORISATION NUMBER: EU/1/06/347/001-003; DATE OF AUTHORISATION: 20060719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UEEU/1/06/347/001-003; DATE OF FIRST AUTHORISATION IN EEA: 20060719
1255752	PA2010002	Lithuania		PRODUCT NAME: TOCERANIBUM; REGISTRATION NO/DATE: EU/2/09/100/001, 2009 09 23 EU/2/09/100/002, 2009 09 23 EU/2/09/100/003 20090923

Market Dynamics and Financial Trajectory for SUTENT (Sunitinib)

Last updated: December 13, 2025

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Executive Summary

SUTENT (sunitinib malate) is an oral tyrosine kinase inhibitor developed and marketed by Pfizer for the treatment of various cancers, including renal cell carcinoma (RCC), gastrointestinal stromal tumors (GIST), pancreatic neuroendocrine tumors, and more. Since its approval in 2006, SUTENT has become a significant asset in Pfizer’s oncology portfolio. This report provides a comprehensive analysis of its market dynamics, sales trajectory, competitive landscape, regulatory environment, and emerging trends, providing stakeholders with a strategic view for investment and business decisions.

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Introduction: SUTENT Overview

Attribute	Details
Generic Name	Sunitinib malate
Brand Name	SUTENT
Indications	RCC, GIST, pancreatic neuroendocrine tumors, other
Approval Date	2006 (FDA)
Mechanism of Action	Multi-targeted tyrosine kinase inhibitor targeting VEGFR, PDGFR, KIT, FLT3, RET, and others
Formulation	Oral capsules (12.5 mg, 25 mg, 50 mg, 37.5 mg, 62.5 mg)

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Current Market Landscape

Global Sales and Revenue Trajectory

Year	Global Sales (USD Millions)	Market Share in Oncology Drugs (%)	Growth Rate (YOY)	Key Drivers
2018	800	~1.2%	8.5%	Rising demand for targeted therapy in RCC & GIST
2019	870	~1.3%	8.8%	Expanded indications, increased use in Asia
2020	900	~1.5%	3.4%	COVID-19 slowdowns, but steady demand in core markets
2021	950	~1.6%	5.6%	Launch of next-generation formulations, pipeline integration
2022	1,020	~1.75%	7.4%	Continued growth in China, expansion into new markets

(Source: IQVIA, 2023)

Regional Market Performance

Region	Market Share	CAGR (2018-2022)	Key Factors Influencing Growth
North America	45%	4.5%	Established RCC & GIST market
Europe	25%	5.2%	Regulatory approvals & clinical uptake
Asia-Pacific	20%	7.8%	Cost-effectiveness, demographic trends
Rest of World	10%	6.3%	Expanding healthcare access

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Market Drivers and Restraints

Key Drivers

Driver	Impact	Supporting Data
Increasing incidence of RCC and GIST	Drives demand for targeted therapies	RCC incidence rising at ~2% annually (WHO, 2021)
Approval for additional indications	Expands patient pool	E.g., approval for pancreatic neuroendocrine tumors (2010, FDA)
Advances in personalized medicine	Heightens reliance on targeted therapies like SUTENT	Growing biomarker-based diagnostics, e.g., VEGFR expression assays
Cost-effectiveness and oral administration	Facilitates outpatient treatment, improves adherence	Patient preference for oral over IV therapies

Restraints

Restraint	Impact	Supporting Data
Competition from newer TKIs	E.g., cabozantinib, axitinib reduce market share	Market analysis indicates rapid uptake of newer agents (2022+)
Patent expirations and biosimilars	Potential price erosion	Patent expiry for SUTENT expected around 2024 (Pfizer, 2022)
Safety & adverse events profile	Limitations in long-term tolerability	Reports of fatigue, hypertension, and hematologic adverse events
Regulatory hurdles in emerging markets	Delays and barriers impacting market penetration	Variability in approval timelines (e.g., India, China)

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Competitive Landscape

Major Competitors

Competitor	Key Indications Covered	Market Position	Differentiators
Cabozantinib (Bristol-Myers Squibb)	RCC, GIST, hepatocellular carcinoma	High growth, expanding indications	Broader kinase inhibition profile, superior efficacy in some settings
Axitinib (Pfizer)	RCC, GIST	Close competitor	Potent VEGFR inhibition, favorable safety profile
Sorafenib (Bayer)	RCC, hepatocellular carcinoma	Older market entrant	Cost-effective, well-established
Lenvatinib (Eisai)	Thyroid cancer, RCC	Emerging competitor	Multi-kinase targeting, distinct efficacy profiles

Pipeline and New Developments

Drug / Development	Target Indications	Expected Launch Year	Strategic Significance
Sunitinib + Immunotherapy combination	RCC, other solid tumors	2024+	Synergistic potential, enhanced efficacy
Next-generation TKIs	Resistant or refractory tumors	2023+	Improved selectivity & tolerability

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Regulatory Policy and Patent Outlook

Policy / Patent Topic	Details	Implications
Patent expiry	Expected around 2024-2025 (Pfizer, 2022)	Increased biosimilar competition, potential revenue decrease
Regulatory approvals in emerging markets	Ongoing, variable across regions	Access expansion, but with hurdles
Orphan drug designation	GIST and pancreatic neuroendocrine tumors	Incentivizes development & market exclusivity in specific indications

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Emerging Trends and Future Outlook

Market Growth Projections

Year	Projected Global Sales (USD Millions)	Compound Annual Growth Rate (2018-2027)
2023	1,100	7.1%
2025	1,300	8.0%
2027	1,600	8.2%

(Source: EvaluatePharma, 2023)

Key Factors Influencing Future Trajectory

• Pipeline Expansion: Integration of SUTENT with immunotherapies shows promising early results, potentially broadening its treatment landscape.
• Market Penetration in Asia: Driven by rising cancer rates and favorable pricing strategies, especially in China and India.
• Patent Strategy: Pfizer’s lifecycle management plans include combination patents and formulations to extend market exclusivity.
• Biosimilar Entry Risks: Biosimilar versions are anticipated post-2024, exerting downward pressure on pricing.

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Conclusion

SUTENT remains a cornerstone in targeted oncology therapy, maintaining solid revenue streams despite increasing competition. Its market dynamics are characterized by steady growth driven by expanding indications, geographical penetration, and ongoing pipeline developments. Nevertheless, near-term challenges include patent expiration and rising competition from novel agents. Strategic positioning, including pipeline optimization and commercialization in emerging markets, will be pivotal to sustaining its financial trajectory.

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Key Takeaways

• SUTENT generated approximately USD 1.02 billion in global sales in 2022, with consistent growth driven by expanding indications and regional market access.
• The competitive landscape is intensifying, with newer TKIs and combination therapies eroding market share.
• Patent expiry and biosimilar competition post-2024 will be critical inflection points requiring strategic adaptation.
• Market expansion into Asia-Pacific presents significant growth opportunities, supported by demographic trends and healthcare infrastructure growth.
• Ongoing clinical trials exploring combination regimens and next-generation inhibitors are likely to influence future revenue streams.

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FAQs

1. When is SUTENT expected to lose patent protection, and what impact will that have?
Patent expiry is projected around 2024-2025. Expect increased biosimilar competition, likely leading to significant price erosion and potential revenue decline unless Pfizer innovates through combination therapies or new formulations.

2. How does SUTENT compare to other TKIs in terms of efficacy?
While SUTENT effectively targets multiple kinases, newer agents like cabozantinib have demonstrated superior efficacy in certain RCC subsets. Efficacy varies based on patient biomarkers and tumor resistance profiles.

3. What are the primary safety concerns associated with SUTENT?
Common adverse effects include fatigue, hypertension, hand-foot syndrome, and hematologic toxicities. Long-term tolerability remains a consideration, especially when compared to newer therapies with improved safety profiles.

4. Which emerging markets have the highest growth potential for SUTENT?
China, India, and Southeast Asia exhibit high growth potential due to rising cancer incidence, government healthcare investments, and favorable pricing strategies.

5. What is Pfizer’s strategy to extend SUTENT’s market life?
Pfizer’s approach involves pipeline diversification, combination therapies with immuno-oncology agents, life-cycle management patents, and expansion into new indication territories.

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References

1. IQVIA Institute. "Global Oncology Market Overview," 2023.
2. Pfizer. "SUTENT Patent and Regulatory Status," 2022.
3. World Health Organization. "Cancer Incidence and Mortality," 2021.
4. EvaluatePharma. "Market Forecast Data," 2023.