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. 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
Finished Product Suppliers / Packagers:	1
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
Argentina	034118	COMPUESTOS DE 2-INDOLINONAS SUSTITUIDAS CON PIRROLES INHIBIDORAS DE PROTEINQUINASAS; SUS COMPOSICIONES FARMACEUTICAS E INTERMEDIARIOS DE SINTESIS
Austria	369359
Australia	2001239770
Australia	3977001
Belgium	2010C009
Bulgaria	107078

Supplementary Protection Certificates for SUTENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2008002	Lithuania		PRODUCT NAME: SUNITINIBUM; REG. NO/DATE: EU/1/06/347/001-003 20070808
1255752	300332	Netherlands		PRODUCT NAME: SUNITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET L-MALAATZOUT; REGISTRATION NO/DATE: EU/1/06/347/001-003 20060724
1255752	CA 2008 00015	Denmark		PRODUCT NAME: SUNITINIB EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER L-MALEATSALTET
1255752	SPC004/2008	Ireland		SPC004/2008: 20081105, EXPIRES: 20210718
1255752	08C0002	France		PRODUCT NAME: SUNITINIB MALATE; REGISTRATION NO/DATE: EU/1/06/347/001 20060724

SUTENT (sunitinib): Market dynamics and financial trajectory, exclusivity-driven pricing pressure, and the generic/biosimilar competitive outlook

Last updated: June 23, 2026

SUTENT (sunitinib malate) remains a legacy oncology cash flow asset but is in sustained volume decline in most developed markets due to multiple generic entries and prior patent expiry. The revenue profile is now dominated by low-to-mid single-digit remaining share in select geographies, continued ASP pressure from generic mix, and life-cycle interventions around dosing, patient support, and formulation/manufacturing continuity rather than new therapeutic exclusivity.

What is SUTENT (sunitinib) and what cancers drive its historical and current demand?

SUTENT is an oral small-molecule tyrosine kinase inhibitor targeting VEGFRs and PDGFRs. Commercial demand historically concentrated on:

• Metastatic renal cell carcinoma (mRCC)
• Gastrointestinal stromal tumor (GIST) after imatinib failure or intolerance
• Pancreatic neuroendocrine tumors (pNET) (where approved, typically later line)
• Additional label refinements by region and regulatory history

Featured snippet answer (demand driver): mRCC and GIST are the main historical revenue anchors, with pNET adding incremental demand later.

How do label boundaries affect market size and prescribing behavior?

Oncologists use sunitinib where benefit-risk and prior therapies align. Demand is sensitive to:

• Sequencing against newer standards of care (IO-IO and IO-TKI regimens in mRCC)
• Post-imatinib and post-other TKIs lines in GIST (with evolving choice among TKIs)
• Treatment discontinuation rates due to adverse events and dose modifications

When do generic versions of SUTENT start to pressure revenue, and how fast does ASP erosion hit?

SUTENT’s revenue trajectory follows a classic originator decline pattern: patent expiry followed by rapid generic penetration and then slower remaining share erosion. The speed of erosion depends on:

• Number of approved ANDA entrants
• Tender and hospital formulary adoption rates
• Wholesale channel stocking and price reset cycles
• Availability of multiple strengths and pack formats

Featured snippet answer (timing): Generic entry typically causes a step-down in net sales followed by a continued decline driven by generic mix, with a slower residual decline after major price resets.

What is the typical financial shape after SUTENT generic launches?

Originators often see:

• A near-term sales drop at launch-year
• Gross-to-net compression due to rebates and reimbursement dynamics
• Margin compression from lower ASP and higher competitive advertising spend
• Product transfer or manufacturing cost reallocation to maintain supply stability

How many patents protected SUTENT and what categories shaped the launch-to-expiry window?

SUTENT’s protection landscape historically spanned several layers: compound, formulation, dosing regimens, and crystalline/polymorph or salt-related claims, depending on jurisdiction and family design. Market access and legal leverage usually came from:

• Composition of matter coverage on sunitinib malate
• Formulation and manufacturing-method improvements
• Method-of-use claims tied to oncology treatment regimens
• Additional patent terms or extensions where available

Featured snippet answer (estate impact): SUTENT’s late-stage market dynamics are driven less by new patent grants and more by the exhaustion of compound and life-cycle claims, enabling widespread generic competition.

Which patent estate segments most impact market exclusivity in oncology TKIs?

For oral oncology drugs like sunitinib, the most commercially relevant segments are:

• Composition-of-matter (core longevity)
• Formulation/process (can delay “at-risk” launches in some cases)
• Method-of-use (may support settlement leverage during ANDA litigation)

What Orange Book status did SUTENT have, and how does Orange Book listing correlate with generic entry risk?

In US practice, Orange Book listings are a proxy for:

• Which patents are listed for each NDA product/strength
• Which patents can be attacked via Paragraph IV (P-IV)
• Which patents can trigger 30-month stay logic and settlement-driven delays

Featured snippet answer (risk link): Orange Book-listed patents for each strength drive the practical risk of generic launch timing.

How do multiple strengths change competitive dynamics?

SUTENT is commonly marketed in multiple tablet strengths. Each strength can have:

• Separate Orange Book listings
• Different generic approval timelines
• Different stocking patterns at wholesalers
• Different tender pricing, which changes effective market share

What Paragraph IV challenges were filed for SUTENT, and how do they affect launch timing?

Where ANDA sponsors file P-IV certifications against listed patents, the economic effect is typically:

• Triggering litigation
• Creating the possibility of a 30-month stay if triggered by final court outcomes
• Leading to consent judgments or settlement agreements that cap launch timing or design-around approaches

Featured snippet answer (economic effect): P-IV filings drive the litigation-based window that can delay initial generic commercialization, but do not usually stop long-run competition once core protections expire.

How do settlements typically shape SUTENT market outcomes?

Common settlement terms that affect financial trajectory include:

• Launch date carve-outs
• Patent licensing for certain products
• Restrictions on design-around claims
• Agreements on non-infringement positions and dismissal schedules

What drug pricing and reimbursement dynamics determine SUTENT profitability during generic competition?

SUTENT profitability under generic competition depends on:

• Net price versus ASP and wholesaler reimbursement dynamics
• The magnitude of rebates, discounts, and patient assistance spend
• Payer formulary status for generic sunitinib versus competing TKIs/IO-TKI combinations
• Availability of patient assistance for lower-cost generics (limited post-entry leverage)

How does hospital formulary behavior accelerate decline?

Once generic sunitinib is entrenched, oncology pathways shift to:

• Payer-preferred TKIs and lower acquisition cost options
• Use of generics for maintenance where clinical equivalence is established
• Substitution at dispensing points, including across multiple strengths

How does SUTENT compare with competing mRCC and GIST therapies in financial exposure?

SUTENT faces two distinct competitive layers.

mRCC competition: displacement by IO-based regimens

In mRCC, the originator’s market share erodes as IO-TKI combinations and other modern regimens become preferred first-line choices. That shifts:

• New patient starts away from sunitinib
• Treatment sequencing away from older VEGFR TKIs
• Overall duration of sunitinib exposure per patient

GIST competition: multi-TKI landscape

In GIST, sunitinib remains a line-based option but competes with:

• Post-imatinib TKIs and more recent sequencing options
• Different regional guideline preferences
• Tolerability-driven switching patterns

Which companies sell generic sunitinib, and how does entrant count change market share velocity?

Generic market dynamics scale with:

• Number of ANDA approvals
• Availability of supply across strengths
• Price and rebate strategy
• Contracting and tender wins

Featured snippet answer (entrant count effect): The more ANDA entrants and multi-source availability, the faster price convergence and the steeper long-run share erosion for the originator.

What contracting mechanics typically decide SUTENT-originator survival time?

Key determinants:

• GPO and hospital group contracting
• National/region tender schedules
• Pharmacy benefit manager (PBM) formulary tiering
• Wholesale acquisition cost tracking and pass-through pricing

How did SUTENT’s manufacturing and supply chain continuity influence revenues during competition?

Even in generic markets, originators can maintain limited share when:

• Supply stability is strong
• Quality and packaging consistency are entrenched
• Patient continuity matters due to tolerability history

SUTENT’s financial trajectory has been affected by:

• Continued supply assurance
• Dose interruption and modification dynamics, which can influence patient adherence and perceived tolerability
• Channel stability ahead of and during generic launches

What litigation or settlement events affected SUTENT market entry timelines?

Patent litigation and settlements affect revenue mainly through:

• Delay of first generic sales
• Control of which strengths enter at launch
• Timing of additional entrants after early settlements

Featured snippet answer (revenue impact): Litigation can slow initial generic penetration but typically does not reverse multi-year decline once core protections and remaining listed patents exhaust.

What FDA status does SUTENT have now, and how do approvals shape commercial prospects?

SUTENT is an established FDA-approved product with mature labeling and long post-approval history. Commercial prospects are driven less by new approvals and more by:

• Ongoing label consistency in oncology treatment standards
• Generic absorption of routine prescribing
• Any region-specific label changes that expand or restrict use

Does SUTENT face any regulatory rollover risks?

For legacy small molecules, regulatory risk is generally tied to:

• Manufacturing site compliance
• Label revisions affecting reimbursement and clinical use
• Post-marketing safety updates that can alter clinician prescribing thresholds

What is SUTENT’s biosimilar risk profile?

As a small-molecule, SUTENT does not have a biosimilar pathway. Competitive risk comes from ANDAs for generic sunitinib, not biologics. The practical “launch risk” is patent/ANDA-driven rather than biologics comparability-driven.

What financial trajectory is consistent with long-run generic pressure for legacy TKIs like SUTENT?

A typical pattern for legacy oncology TKIs after generic entry:

1. Originator net sales peak then plateau into late exclusivity
2. Generic launch year triggers a sharp decline
3. Subsequent years show continued but slower decline as generics capture remaining share
4. Revenue stabilizes at a lower run-rate where originator supply, contracts, or clinical continuity persist

Featured snippet answer (trajectory): sustained decline post-early generics with residual demand in specific contracting and continuity pockets.

Key market-dynamics table: what to watch in SUTENT revenue going forward

Market driver	What changes it	Expected effect on originator revenue
Generic sunitinib multi-source availability	Additional ANDA entrants	Faster ASP convergence, share loss
PBM and payer formulary placement	Tiering decisions, prior auth	Reduced originator net sales
Hospital tender cycles	Contract renewals	Step-down each cycle if lowest-cost generic wins
Competitor IO-TKI standards in mRCC	Guideline and evidence shifts	Fewer new sunitinib starts
Patient adherence and tolerability	Dose modification patterns	Limited persistence on originator in continuity cases
Supply stability	Manufacturing disruptions	Volatility in originator sales, not long-term reversal

Key Takeaways

• SUTENT’s market dynamics are dominated by generic sunitinib competition and displacement by newer mRCC standards and multi-TKI pathways in GIST.
• Financial trajectory is consistent with long-run originator decline: steep early erosion after generic entry, followed by slower residual share loss tied to contracting, supply continuity, and patient treatment continuity.
• Exclusivity-driven events (Orange Book listings, P-IV challenges, litigation, settlements) affect launch timing but do not typically change the multi-year economics once core protections expire.
• Competitive pressure is structural: additional generic entrants and payer/hospital procurement rules compress pricing and reduce originator relevance in routine prescribing.

FAQs

1. What happens to SUTENT net sales after each major generic tender cycle?
2. Which SUTENT strengths face the fastest generic share capture and why?
3. How do IO-TKI mRCC treatment guidelines reduce sunitinib initiation rates?
4. What settlement terms most influence which generic strengths launch first?
5. How do rebates and patient assistance programs change once generics dominate the market?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
3. FDA. (n.d.). Generic Drug User Fee Amendments and ANDA framework background. U.S. Food and Drug Administration. https://www.fda.gov/

DrugChatter Q&A for SUTENT

What are the benefits of Sutent?