STIVARGA Drug Patent Profile

When do Stivarga patents expire, and when can generic versions of Stivarga launch?

Stivarga is a drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-eight patent family members in forty-nine countries.

The generic ingredient in STIVARGA is regorafenib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the regorafenib profile page.

DrugPatentWatch^® Generic Entry Outlook for Stivarga

Stivarga was eligible for patent challenges on September 27, 2016.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for STIVARGA

International Patents:	168
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	84
Patent Applications:	4,588
Drug Prices:	Drug price information for STIVARGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STIVARGA
What excipients (inactive ingredients) are in STIVARGA?	STIVARGA excipients list
DailyMed Link:	STIVARGA at DailyMed

See drug prices for STIVARGA

Recent Clinical Trials for STIVARGA

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

Sponsor	Phase
Asan Medical Center	PHASE1
Mirror Biologics, Inc.	PHASE2
Great Novel Therapeutics Biotech & Medicals Corporation	Phase 1/Phase 2

See all STIVARGA clinical trials

Pharmacology for STIVARGA

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inhibitors Kinase Inhibitors UGT1A1 Inhibitors UGT1A9 Inhibitors

Paragraph IV (Patent) Challenges for STIVARGA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STIVARGA	Tablets	regorafenib	40 mg	203085	2	2016-09-27

US Patents and Regulatory Information for STIVARGA

STIVARGA is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes			Y	Y
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes			Y

Expired US Patents for STIVARGA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012

EU/EMA Drug Approvals for STIVARGA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer Pharma AG	Stivarga	regorafenib	EMEA/H/C/002573Stivarga is indicated as monotherapy for the treatment of adult patients with:metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy;unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib;hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.	Authorised	no	no	no	2013-08-26

International Patents for STIVARGA

When does loss-of-exclusivity occur for STIVARGA?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Denmark

Dominican Republic

Ecuador

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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 STIVARGA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2129376	Traitement de cancers à résistance acquise aux inhibiteurs KIT (Treatment of cancers with acquired resistance to KIT inhibitors)
Israel	144030	OMEGA- CARBOXYARYL SUBSTITUTED DIPHENYL UREAS, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM AND THEIR USE FOR THE PREPARATION OF MEDICAMENTS FOR INHIBITING RAF KINASE
Portugal	1690853

Supplementary Protection Certificates for STIVARGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140840	SPC/GB07/004	United Kingdom		PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1140840	CA 2007 00002	Denmark		PRODUCT NAME: SORAFENIB TOSYLAT
1140840	PA 2006 008, C 1140840	Lithuania		PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719

STIVARGA (regorafenib): Market dynamics and financial trajectory

Last updated: April 24, 2026

What is STIVARGA’s market structure and why does it matter?

STIVARGA (regorafenib) is a small-molecule multikinase inhibitor marketed for metastatic and unresectable cancers across multiple lines of therapy. Its commercial profile is shaped by four recurring forces: (1) label expansion across distinct oncology indications, (2) competitive pressure from newer targeted agents and immuno-oncology combinations, (3) pricing and reimbursement intensity across major markets, and (4) manufacturing and supply ramp dynamics following major approvals and formulation lifecycle changes.

Commercial outcomes typically track three measurable variables: (a) total addressable patient starts across approved settings, (b) net price after rebates and payer contracting, and (c) share erosion when guideline-preferred regimens shift.

How has STIVARGA performed financially in the market?

The most decision-relevant financial signals for STIVARGA come from the manufacturer’s oncology segment reporting and biannual portfolio commentary rather than isolated product-level disclosures. STIVARGA is marketed in the US and key international territories by Bayer (brand) and has historically been disclosed within Bayer’s Pharmaceuticals segment and oncology franchise narratives.

Because STIVARGA is not separately reported in most annual financial tables in a way that supports clean quarter-by-quarter modeling, the practical approach for investors is to triangulate using:

• Bayer’s disclosed Pharmaceuticals and oncology franchise revenue trends
• indication-specific uptake and guideline positioning (seen through trial readouts, label changes, and competitive launches)
• payer policy signals (step edits, prior authorization tightening, preferred formulary placement)

Snapshot: where STIVARGA fits in oncology spending

Regorafenib is an “oral, later-line” option in multiple tumor types. That placement typically creates a revenue profile that is:

• Less volatile than frontline immuno-oncology in the short term
• More exposed to guideline shifts when preferred sequences change
• Sensitive to payer restrictions because later-line use depends on prior treatment documentation and clinical criteria

What has driven growth or contraction by indication?

STIVARGA’s market dynamics are best understood by mapping label breadth to patient flow and then adjusting for competition in each tumor type. The label history below reflects the commercial “coverage map” that supports the addressable base.

Key approved uses that drive patient starts

STIVARGA has approvals in multiple settings including (examples below reflect major commercial use cases):

• Metastatic colorectal cancer (mCRC) previously treated with standard therapies
• Gastrointestinal stromal tumor (GIST) after prior kinase inhibitor therapy
• Hepatocellular carcinoma (HCC) after prior sorafenib
• Renal cell carcinoma (RCC) after prior VEGF and immune therapies (where applicable to label and region)

These approvals create a portfolio that can offset softness in any one tumor type when other indications hold up.

The main “market drift” risks

In each indication, revenue durability is challenged by:

• Sequence displacement: earlier lines adopt newer agents, reducing later-line volume
• Payer tightening: more rigid criteria for “eligible after prior therapy” documentation
• Toxicity and discontinuation: oral multikinase inhibitors have discontinuation sensitivity that translates into reduced effective duration and lower patient exposure

How do competitive launches affect STIVARGA’s revenue trajectory?

STIVARGA’s commercial exposure is unusually high to “standard of care drift.” In oncology, guideline updates often move clinicians away from older multikinase inhibitors when targeted or immuno-based strategies improve outcomes earlier in the sequence.

Competitive pressure tends to appear in two waves:

1. Short-cycle pressure when new agents gain uptake in earlier lines, shrinking later-line patient pools.
2. Mid-cycle pressure when payer policy shifts to preferentially cover newer products first, pushing regorafenib to narrower patient subsets.

That dynamic is particularly relevant for later-line assets because patient flow depends on prior regimen history. When preferred regimens expand, the proportion of patients reaching regorafenib criteria falls even if absolute disease incidence remains stable.

What pricing, reimbursement, and access dynamics shape net sales?

For oral oncology drugs, net sales in practice are defined by net price and utilization. Even without a product-level net price table, the determinants are consistent across major markets:

• Formulary placement: preferred vs non-preferred status changes persistence and volume capture
• Rebate and discount intensity: affects net price and can compress growth even when gross demand rises
• Prior authorization step edits: constrain use to strict prior therapy sequences and documented eligibility
• Dose intensity and adherence realities: multikinase inhibitors face dose interruptions and discontinuations; payer policies sometimes tie authorization to expected clinical appropriateness

These factors translate into a common financial pattern for STIVARGA: periods of label-driven sales growth followed by flattening as contracting and competition intensify.

What role does supply chain and lifecycle management play?

STIVARGA’s commercial performance also depends on manufacturing continuity and distribution reliability. Oral small molecules can scale supply faster than biologics, but revenue still depends on:

• Batch availability during demand inflections
• Distribution channel stability
• Formulation lifecycle changes
• Global coordination for major seasonal demand swings driven by treatment starts

In practice, supply shocks would show up as reduced patient starts rather than as later-line reimbursement differences. For investment underwriting, supply risk typically has lower tail impact than competitive and payer risks.

How does regulatory and clinical evidence influence ongoing market adoption?

In later-line oncology, market adoption tracks evidence that supports both:

• Clinical benefit vs current standard sequences
• Safety manageability that affects persistence

For STIVARGA, acceptance also depends on label alignment with real-world practice criteria and the presence of clinician confidence in managing adverse events.

When label expansions occur, they can widen the patient pool quickly. When expansions do not occur or when confirmatory evidence fails to shift guideline placement, revenue typically stabilizes and then erodes.

What financial trajectory is most consistent with STIVARGA’s market dynamics?

Given STIVARGA’s later-line profile across multiple tumor types, the trajectory most consistent with typical market behavior is:

• Growth driven by incremental label uptake and broadening physician comfort
• Flattening as payer restrictions and competitive sequencing compress market share
• Ongoing decline if newer regimens repeatedly displace later-line multikinase use

This pattern is consistent with how multikinase inhibitor brands typically behave once the bulk of addressable patient population shifts earlier in the treatment path.

Where does STIVARGA stand today in portfolio terms?

From an investor perspective, STIVARGA’s relevance depends less on “peak sales potential” and more on:

• Whether regorafenib maintains meaningful share in at least two anchor indications
• Whether guideline positioning keeps regorafenib in the patient journey
• Whether net price erosion is offset by stable starts

In oncology portfolios, these factors determine whether the product contributes as a stabilizer or becomes a declining cash flow contributor.

What are the biggest upside and downside levers?

Upside levers

• Expanded or strengthened label positioning within high-volume tumor settings
• Evidence that improves persistence and reduces discontinuations through manageable safety regimens
• Improved payer access outcomes, including reduced step-edit friction

Downside levers

• Guideline shifts that move more eligible patients to earlier-line regimens
• Payer restrictions tightening “after prior therapy” documentation requirements
• Share erosion driven by therapies with stronger efficacy or better tolerability in the same sequencing space

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Key Takeaways

• STIVARGA’s market is built on later-line oncology positioning across multiple tumor types, which makes patient starts sensitive to sequence displacement and payer criteria.
• Financial trajectory typically follows label-driven adoption followed by flattening and then decline as newer agents shift treatment standards and reduce eligible later-line volume.
• Net sales are dominated by net price and utilization (starts and persistence), not by gross incidence.
• Competitive and reimbursement dynamics are the primary drivers of mid-term revenue outcomes; supply and lifecycle issues are usually secondary.

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FAQs

1. Is STIVARGA a frontline oncology drug?
   No. STIVARGA is generally positioned in metastatic, advanced, or post-prior-therapy settings, so its commercial volume depends heavily on treatment sequencing.

2. What most determines STIVARGA’s net sales over time?
   The combination of patient starts reaching eligibility criteria and net price after payer contracting, plus persistence shaped by adverse event management.

3. How does competition affect regorafenib brands like STIVARGA?
   Competition affects the size of the later-line patient pool and share by moving standard care earlier and tightening formulary and authorization policies.

4. What is the biggest risk to STIVARGA’s revenue trajectory?
   Continued displacement of later-line multikinase inhibitor use by newer regimens and payer policies that preferentially cover those therapies first.

5. What is the primary source of demand for STIVARGA?
   Ongoing oncology patient flow in approved tumor types, driven by clinician treatment decisions aligned to guideline sequencing and payer coverage rules.

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References

[1] U.S. Food and Drug Administration. (2024). STIVARGA (regorafenib) prescribing information. FDA. https://www.accessdata.fda.gov
[2] Bayer. (annual). Annual Report and Form 20-F / Investor Relations materials. Bayer AG. https://www.bayer.com/en/investors
[3] European Medicines Agency. (2024). STIVARGA product information and assessment reports. EMA. https://www.ema.europa.eu