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
Lithuania	PA2008002
Poland	211834
Germany	60129794
Poland	361209
Australia	784266

Supplementary Protection Certificates for SUTENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	91657	Luxembourg		91657, EXPIRES: 20240923
1255752	2010C/009	Belgium		PRODUCT NAME: TOCERANIB; AUTHORISATION NUMBER AND DATE: EU/2/09/100/001 20090923
1255752	5/2008	Austria		PRODUCT NAME: SUNITINIB, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES L-MALAT-SALZES; REGISTRATION NO/DATE: EU/1/06/347/001- EU/1/06/347/003 20060719
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	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

SUTENT (sunitinib): Market dynamics and financial trajectory

Last updated: April 24, 2026

What is SUTENT and where does it fit in the oncology market?

SUTENT is the brand name for sunitinib, an oral small-molecule multi-target tyrosine kinase inhibitor (TKI) used in multiple cancers. In commercial terms, SUTENT’s trajectory reflects the classic pattern of an oncology launch that (1) scales with initial uptake, (2) holds share against competing TKIs, and (3) declines as later-generation therapies, combination regimens, and branded/generic entry compress pricing and volumes.

Key commercial characteristics that shape market dynamics:

• Oral oncology TKI category exposure: SUTENT competes in a crowded TKIs landscape where clinical positioning and tolerability drive sequencing.
• Multi-indication footprint: Revenue is sensitive to label strength, guideline inclusion, and prescriber preference by cancer type.
• Patent and exclusivity-driven price compression: Sunitinib is now off-patent in major markets, shifting the market structure toward generic penetration and brand discounting.

How has the brand’s revenue evolved over time?

SUTENT’s financial trajectory is captured in Pfizer’s segment disclosures and product-level reporting (where available). Across the period when SUTENT was a meaningful contributor, revenue scaled early and then fell as competitors and generics took share.

Representative financial trajectory from Pfizer filings

Public Pfizer reporting shows SUTENT as a legacy oncology franchise with declining sales in later years.

Fiscal year (Pfizer reporting basis)	SUTENT net revenues	Directional read-through
Early-to-mid life cycle	Material franchise revenue	Expansion phase with multi-indication use
Later life cycle	Declining net revenues	Share erosion from competition and product aging
Post-branded life cycle	Lower, then largely replaced	Generic pressure drives brand erosion

Pfizer’s Form 10-K disclosures list SUTENT within a set of product net revenues (and have historically shown SUTENT as declining versus peak years) (source: Pfizer annual report product tables) [1][2][3].

Why did SUTENT’s market dynamics shift?

SUTENT’s decline is consistent with four market mechanisms that repeatedly affect oral oncology brands:

1. Generic entry and channel pull-through

   • Sunitinib has long been subject to generic competition in major markets.
   • Once generic availability expands, payer behavior typically shifts toward lowest-cost supply, and brand revenue erodes quickly.

2. Competition within the TKI class

   • The oncology TKI market added multiple “next-step” drugs and refined treatment sequences.
   • Prescribers increasingly optimize first-line and later-line treatment choice by tumor context and toxicity profile.

3. Combination regimen substitution

   • Over time, oncology standard of care increasingly uses combinations with checkpoint inhibitors and other targeted agents.
   • This can reduce the addressable patient population for standalone TKI strategies even when TKIs remain clinically relevant.

4. Indication-level saturation

   • As a drug matures, incremental growth slows even without competitive displacement.
   • Without new, high-growth indications, the remaining addressable population declines with aging and disease incidence dynamics.

What do payer and procurement incentives imply for SUTENT’s brand economics?

Once generics dominate, SUTENT’s brand economics face structural constraints:

• Wholesale and formulary pressure: Formularies often prefer generics unless SUTENT retains a distinctive differentiation in coverage terms or contracting.
• Price-volume tradeoff: Brand discounts can buy time but generally cannot offset generic price benchmarks long term.
• Net-to-gross compression: Higher discounting to maintain channel access can accelerate margin erosion even where volume holds briefly.

These forces are visible across legacy branded products in oncology after patent expiry, and they align with Pfizer’s product reporting pattern for older franchises like SUTENT (source: Pfizer annual report product revenue tables) [1][2][3].

How did litigation and regulatory status influence the timeline?

SUTENT’s commercial course also reflects the patent and regulatory landscape typical for branded oncology drugs. Sunitinib’s path to generic availability required patent challenge outcomes and regulatory approvals that determined when lower-cost competitors could enter.

• Pfizer’s SEC filings for legacy oncology brands summarize material legal proceedings, including the effect of patent status on commercialization and potential royalty or settlement implications (source: Pfizer annual filings legal proceedings context and product-level reporting) [1][2][3].

What are the main competitors and how do they affect substitution risk?

In practice, SUTENT faces substitution within:

• RCC (renal cell carcinoma) treatment lines, where multiple TKIs and immuno-oncology combinations compete for the same patient treatment windows.
• GIST (gastrointestinal stromal tumor) sequencing, where newer TKIs and lines of therapy can shift use away from sunitinib depending on prior exposure and tolerability.
• Other solid tumors where TKIs historically had label scope but later clinical standards broadened across modalities.

Competitive pressure does not require complete therapeutic replacement. It can operate through:

• Earlier line displacement (patient counts move to new standards),
• Later line crowding (fewer eligible patients reach sunitinib),
• Dose intensity and tolerability tradeoffs that shift patient-specific selection.

This substitution dynamic is consistent with how Pfizer reports declining net revenues for legacy products in its annual product tables (source: Pfizer annual reports) [1][2][3].

What does the brand lifecycle imply for future cash flow?

Given the generic reality of sunitinib in major markets, SUTENT’s future financial contribution is typically characterized by:

• Limited upside from volume growth (generic substitution caps brand share),
• Residual revenue from remaining branded preference, contracting, or supply continuity needs,
• Ongoing margin erosion as incentives tighten.

Cash flow profile usually shifts from “growth franchise” to “legacy line item,” with operating focus shifting to newer pipeline assets.

Is SUTENT still economically material for Pfizer?

The available public financial context positions SUTENT as a legacy oncology product rather than a primary growth driver. Pfizer’s product net revenue reporting over time shows aging franchises as smaller components of the portfolio, with the company’s strategic emphasis moving to newer products in subsequent reports (source: Pfizer annual product revenue tables and segment reporting) [1][2][3].

Key market dynamics summary for investors

SUTENT’s market behavior tracks a predictable post-launch curve for branded oncology TKIs:

• Peak and scale driven by label breadth and TKI standard-of-care inclusion,
• Erosion from (a) generic entry, (b) TKI competition, and (c) shift toward combination regimens,
• Stabilization at a lower base if branded supply retains some contracted usage, then eventual “legacy-only” status.

Key Takeaways

• SUTENT’s commercial curve is consistent with an oncology TKI that scaled early and then declined under generic penetration, TKI competition, and changing treatment sequences.
• Pfizer’s public reporting shows SUTENT as a legacy franchise with declining net revenues versus peak years (source: Pfizer annual reports product tables) [1][2][3].
• Post-exclusivity economics are structurally constrained by payer and procurement incentives that favor generics.

FAQs

1) What is the core reason SUTENT revenues declined?

Generic competition plus substitution within oncology treatment sequences compressed both volume and net price over time, consistent with Pfizer’s declining product revenue reporting for legacy brands [1][2][3].

2) Does SUTENT face competition from within the same drug class?

Yes. SUTENT competes against other oral oncology TKIs used in overlapping indications, and prescribers can shift choice based on sequencing, tolerability, and guideline updates [1][2][3].

3) Can brand discounting prevent revenue erosion after generic entry?

It can slow decline temporarily, but it generally cannot fully offset generic benchmark pricing and formulary switching, which is reflected across legacy branded oncology products’ revenue patterns in Pfizer filings [1][2][3].

4) Is SUTENT’s financial trajectory still investable as a growth story?

The public financial trajectory frames SUTENT as legacy exposure rather than a growth engine, with portfolio focus moving to newer assets as reflected in Pfizer’s later product mixes [1][2][3].

5) Where does market sensitivity show up most for SUTENT?

Primarily in indication mix shifts and in payer coverage decisions as competitive standards evolve, which drive patient eligibility and persistence and show up in product net revenue tables over successive years [1][2][3].

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References (APA)

[1] Pfizer Inc. (2017). Form 10-K: Annual report. U.S. Securities and Exchange Commission. https://www.sec.gov/
[2] Pfizer Inc. (2021). Form 10-K: Annual report. U.S. Securities and Exchange Commission. https://www.sec.gov/
[3] Pfizer Inc. (2023). Form 10-K: Annual report. U.S. Securities and Exchange Commission. https://www.sec.gov/