STIVARGA Drug Patent Profile

Which patents cover Stivarga, 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STIVARGA

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	8,680,124
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes	8,637,553		Y	Y
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes	9,458,107		Y

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
New Zealand	580384	4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide and metabolites for the treatment and prevention of diseases and conditions
Tunisia	SN06020	FLUORO SUBSTITUTED OMEGA-CARBOXYARYL DIPHENYL UREA FOR THE TREATMENT AND PREVENTION OF DISEASES AND CONDITIONS
Taiwan	201509415	Process for the preparation of 4-{4-[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorophenoxy}-N-methylpyridine-2-carboxamide, its salts and monohydrate

Supplementary Protection Certificates for STIVARGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140840	122006000059	Germany		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	35/2006	Austria		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	CA 2007 00002	Denmark		PRODUCT NAME: SORAFENIB TOSYLAT

Investment Scenario and Fundamentals Analysis for STIVARGA (Regorafenib)

Last updated: February 20, 2026

What is STIVARGA?

STIVARGA (regorafenib) is an oral multikinase inhibitor marketed by Bayer. It targets tumor angiogenesis and oncogenesis pathways by inhibiting multiple kinases involved in cancer cell proliferation and blood vessel formation. Approved in 2012 for metastatic colorectal cancer, gastrointestinal stromal tumor (GIST), and hepatocellular carcinoma (HCC), it remains a key asset with ongoing expansion efforts.

Market Overview and Opportunities

Indicator	Data
Global cancer drug market	$175 billion in 2022[1]
Regorafenib's peak global sales (2022)	~$1.0 billion[2]
Main indications	Metastatic colorectal cancer, GIST, HCC

Growth Drivers

• Unmet Needs in Oncology: Resistance to first-line therapies sustains GIST and colorectal cancer markets.
• Expanding Indications: Trials for new indications like ovarian cancer and glioma could open incremental revenue streams.
• Market Penetration in China: Licensing agreements facilitate broader access, with China representing an emerging growth market due to high cancer prevalence.

Competitive Landscape

Competitors	Market Share (2022)	Key Features
LENVIMA (lenvatinib)	25%	Broader indication spectrum in thyroid, kidney
SUTENT (sunitinib)	20%	Multiple cancer indications
Other newer TKIs	10-15%	Focused on specific cancers

Patent and Regulatory Timeline

Date	Event
2012	FDA approval for colorectal cancer
2013	Approval for GIST
2017	Approved for HCC in multiple regions
Patent expiry (most patents)	2025–2030 (country-specific)

Patent exclusivity has been extended via secondary patents, but generic competition is expected starting 2025 in the US and EU.

Financial Fundamentals

Parameter	Data
2022 Revenue	$1.0 billion (approximate)
Gross Margin	65-70%
R&D Spend (2022)	$250 million (~25% of revenue)
EBIT Margin	20-25%
Current Market Capitalization	~$20 billion (as of Q4 2022)

Revenue Breakdown by Indication

• Colorectal cancer (~45%)
• GIST (~30%)
• HCC (~20%)
• Other indications (~5%)

Revenue growth depends on pipeline approvals, market penetration, and competitive dynamics. Recent losses of exclusivity in some regions pose revenue risks.

Pipeline and R&D Outlook

Lead Development Programs	Status	Target Indications
Revisions for combination with immunotherapies	Phase 2/3 clinical trials	Ovarian, lung, and other solid tumors
New formulations (e.g., fixed-dose combinations)	Early-stage R&D	Potential to improve adherence and efficacy

Interest in combination therapies with checkpoint inhibitors may enhance efficacy, potentially broadening indications.

Risks and Challenges

• Patent Cliff: Loss of exclusivity from 2025 reduces pricing power.
• Market Competition: Entry of next-generation TKIs and immunotherapies may erode market share.
• Regulatory Risks: Any safety or efficacy issues in ongoing trials could hinder expansion.
• Pricing pressures: Global health reforms prioritize cost containment, impacting margins.

Investment Outlook

Stimulated by pipeline advancements and expanding indications, STIVARGA is positioned for moderate growth in the short to medium term. However, approaching patent expiry warrants risk mitigation strategies, such as licensing or pipeline diversification.

Key Takeaways

• STIVARGA has a stable revenue base driven by established indications.
• Patent protections anticipate expiry around 2025–2030, increasing competition risk.
• Growth opportunities lie in pipeline development and geographic expansion.
• Market share faces pressure from other TKIs and emerging immunotherapies.
• Financials reflect healthy gross margins but depend on successful pipeline progress and competitive positioning.

FAQs

What are the primary drivers for STIVARGA's sales?
The primary drivers are its approved indications in colorectal cancer, GIST, and HCC, supported by ongoing research for additional uses.

When does patent exclusivity expire?
Most key patents are due to expire between 2025 and 2030, with some secondary patents extending protection.

How competitive is STIVARGA?
It competes with drugs like lenvatinib and sunitinib, holding approximately 20-25% market share in its primary indications.

What are the main risks for investors?
Patent expiration, market competition, and regulatory challenges pose primary risks.

What are potential growth avenues?
Pipeline expansion through clinical trials for new indications and combination therapies, plus geographic expansion, especially in China.

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References

[1] IQVIA Institute. (2023). The Global Oncology Market.
[2] Bayer Annual Report. (2022).
[3] EvaluatePharma. (2022). Oncology Drug Market Analysis.