SUTENT Drug Patent Profile

When do Sutent patents expire, 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. Ten 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

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

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
Argentina	034118	COMPUESTOS DE 2-INDOLINONAS SUSTITUIDAS CON PIRROLES INHIBIDORAS DE PROTEINQUINASAS; SUS COMPOSICIONES FARMACEUTICAS E INTERMEDIARIOS DE SINTESIS
Austria	369359
Australia	2001239770

Supplementary Protection Certificates for SUTENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	C 2010 003	Romania		PRODUCT NAME: (Z)-5-[(5-FLUORO-2-OXO-1,2-DIHIDRO-3H-INDOL-3-ILIDEN)METIL}-2,4-DIMETIL-N-(2-PIROLIDIN-1-ILETIL)-1H-PIROL-3-CARBOXAMIDA - TOCERANIB, INCLUSIV SUB FORMA DE FOSFAT; NATIONAL AUTHORISATION NUMBER: RO EU/2/09/100/001, RO EU/2/09/100/002, RO EU/2/09/100/003; DATE OF NATIONAL AUTHORISATION: 20090923; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/2/09/100/001, EMEA EU/2/09/100/002, EMEA EU/2/09/100/003; DATE OF FIRST AUTHORISATION IN EEA: 20090923
1255752	2010C/009	Belgium		PRODUCT NAME: TOCERANIB; AUTHORISATION NUMBER AND DATE: EU/2/09/100/001 20090923
1255752	C01255752/02	Switzerland		PRODUCT NAME: TOCERANIB; REGISTRATION NO/DATE: SWISSMEDIC 60121 09.07.2010

Last updated: February 3, 2026

What Is the Market and Financial Profile of SUTENT?

SUTENT (sunitinib malate) is a targeted cancer therapy developed by Pfizer. It is an oral tyrosine kinase inhibitor approved mainly for renal cell carcinoma (RCC), gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors (pNET). Its global sales peaked at approximately $770 million in 2019 before declining due to market saturation and generic competition.

How Has SUTENT Performed Financially?

Pfizer reports consistent sales of SUTENT, with recent figures in the range of $450–$550 million annually. Post-patent expiry in key markets, generic competition has eroded margins, reducing revenue growth. The drug's patent expired or faced imminent expiry in major markets such as the U.S. and Europe by 2021–2022.

Pfizer's R&D pipeline includes next-generation kinase inhibitors aiming to improve efficacy and resistance profiles, which could impact SUTENT's market share.

What Are the Key Market Drivers and Risks?

Market Drivers

• Increasing prevalence of RCC and GIST results in sustained demand.
• Advances in targeted therapy improve treatment outcomes and expand indications.
• Regulatory approvals for combination therapies are expanding SUTENT's clinical utility.

Market Risks

• Patent expiry and resulting generic competition affect pricing and sales.
• Emergence of next-generation therapies with superior efficacy.
• Pricing pressures from healthcare systems and payers.
• Potential safety issues or market withdrawals due to adverse effects.

What Is the Competitive Landscape?

SUTENT faces competition from other tyrosine kinase inhibitors like axitinib, cabozantinib, and newer agents such as immunotherapies (e.g., nivolumab). Unlike SUTENT, immunotherapies are often associated with durable responses in RCC, challenging reliance on kinase inhibitors.

How is the Patent and Regulatory Environment Evolving?

SUTENT's core patent has expired or is about to expire in key markets as of 2022. Pfizer has secured some patents related to specific formulations or combination uses, but these offer limited protection. Regulatory agencies are approving biosimilars or generic versions in multiple regions, accelerating exposure to price competition.

What Is the Investment Outlook Based on Fundamentals?

SUTENT's revenue outlook depends on:

• The longevity of existing indications.
• Market share retention amid competition.
• Growth in secondary indications or combination regimens.
• Success of Pfizer's pipeline candidates in mesothelioma, liver cancers, or other solid tumors.

Current valuations suggest a declining revenue trajectory post-generic entry unless Pfizer innovates or secures new indications.

How Should Investors Approach SUTENT?

Investors should consider:

• A declining revenue profile due to patent expiry.
• The potential for pipeline successes to offset sales erosion.
• Pfizer’s strategy to defend market share through line extensions or combination therapies.
• The impact of biosimilars and generics on future profitability.

Due diligence should include monitoring patent litigations, regulatory filings for new indications, and competitive developments in RCC and GIST treatments.

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Key Takeaways

• SUTENT, once a blockbuster drug, faces revenue decline after patent expiration.
• The drug’s core market is shrinking; competition from immunotherapies and generics intensifies.
• Pfizer’s pipeline and strategic initiatives will influence future valuation.
• Market growth hinges on expanding indications and combination use.
• Investors must weigh the drug's declining legacy against pipeline prospects and market positioning.

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FAQs

1. When did Pfizer's patent protections for SUTENT expire?
Major patents in the U.S. and Europe expired around 2021–2022, enabling biosimilar and generic competition.

2. What are the primary indications for SUTENT?
Renal cell carcinoma, gastrointestinal stromal tumors, and pancreatic neuroendocrine tumors.

3. How does SUTENT compare to immunotherapies in RCC?
Immunotherapies such as nivolumab show higher durability of response but may be used in different patient populations or in combination with kinase inhibitors like SUTENT.

4. What pipeline assets could impact SUTENT's market?
Pfizer's forthcoming kinase inhibitors and immunotherapies may supplement or replace SUTENT in treatment lines if approved and more effective.

5. How does biosimilar competition affect pricing?
Biosimilars typically reduce prices by 20–40%, pressuring revenues for original branded drugs like SUTENT.

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References

[1] Pfizer Annual Reports, 2019–2022.
[2] IQVIA Data, 2022.
[3] FDA and EMA Regulatory Filings.