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
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
Honduras	2000000007	UREAS DIFENIL - CARBOXIARIL SUSTITUIDAS COMO INHIBIDORES DE RAFQUINASA.
China	101547903	4-[4-({[4-chloro-3-(trifluoromethyl)phenyl)]carbamoyl}amino)-3-fluorophenoxy]-n-methylpyridine-2-carboxamide monohydrate
China	102947271	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
Denmark	1690853
Czech Republic	20012489
Eurasian Patent Organization	200600317	ПРОИЗВОДНЫЕ ОМЕГА-КАРБОКСИАРИЛДИФЕНИЛМОЧЕВИНЫ (ВАРИАНТЫ), ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ И ПРЕДУПРЕЖДЕНИЯ ЗАБОЛЕВАНИЙ И СОСТОЯНИЙ С ИХ ИСПОЛЬЗОВАНИЕМ (ВАРИАНТЫ)
South Korea	101800041

Supplementary Protection Certificates for STIVARGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663978	2013C/067	Belgium		PRODUCT NAME: STIVARGA-REGORAFENIB; AUTHORISATION NUMBER AND DATE: EU/1/13/858 20130829
1663978	SPC/GB13/076	United Kingdom		PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTERED: UK EU/1/13/858/001 20130829; UK EU/1/13/858/002 20130829
1140840	91280	Luxembourg		91280, EXPIRES: 20210720
1663978	2013/050	Ireland		PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826
1140840	SZ 35/2006	Austria		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
1140840	PA2006008,C1140840	Lithuania		PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	06C0034	France		PRODUCT NAME: SORAFENIB TOSYLATE, ET AUTRES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE SORAFENIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/342/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/342/001 DU 20060719

Market Dynamics and Financial Trajectory for STIVARGA (Regorafenib)

Last updated: January 1, 2026

Executive Summary

STIVARGA (regorafenib) is an oral multikinase inhibitor approved for multiple oncological indications, including metastatic colorectal cancer (mCRC), gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma (HCC). Since its FDA approval in 2012, STIVARGA has faced intense competition alongside evolving treatment paradigms. This comprehensive analysis evaluates the current market landscape, key drivers, competitive pressures, and projected financial trajectory over the next five years.

Overview of STIVARGA (Regorafenib)

Attribute	Details
Generic Name	Regorafenib
Brand Name	STIVARGA
FDA Approval Date	September 2012
Indications	mCRC, GIST, HCC
Mechanism of Action	Multikinase inhibitor targeting VEGFR, TIE2, RAF, and others
Formulation	Oral tablets
Dosage	Various, typically 160 mg daily for initial dosing

Market Landscape and Dynamics

1. Current Market Size and Segmentation

Indication	Market Valuation (USD billion, 2022)	Estimated Growth Rate ( CAGR, 2022-2027)	Key Competitors
Metastatic Colorectal Cancer	1.2	4.5%	Regorafenib, TAS-102, Bevacizumab, Cetuximab
Gastrointestinal Stromal Tumors	0.4	3.8%	Imatinib, Sunitinib, Ripretinib
Hepatocellular Carcinoma	0.75	6.2%	Sorafenib, Lenvatinib, Atezolizumab + Bevacizumab

Source: IQVIA, 2022; industry reports.

2. Drivers of Market Growth

• Expanding Indications: Recent approvals and ongoing trials aim to expand regorafenib's use, including in unresectable biliary tract cancers.
• Unmet Medical Needs: Increasing incidence of colorectal and liver cancers, especially in aging populations, sustains demand.
• Evolving Treatment Paradigms: Combining regorafenib with immunotherapies or other targeted agents may enhance efficacy, creating new revenue streams.
• Regulatory Approvals: Fast-track designations in certain markets accelerate approval processes, broadening access.

3. Challenges and Barriers

Challenge	Impact
Competition from newer agents (e.g., Ripretinib)	Market share erosion
Side effect profile (e.g., hypertension, hand-foot skin reaction)	Limits patient tolerability
Biosimilar penetration (if applicable)	Price erosion and reduced margins
Development pipeline delays	Opportunity costs and strategic uncertainty

4. Competitive Landscape

Competitor	Mechanism of Action	Origin	Approval Year	Market Share (est.)	Key Differentiators
Regorafenib	Multikinase inhibitor	Bayer AG	2012	50% (mCRC segment)	Broad kinase targeting, multiple pathways
Lenvatinib	VEGFR inhibitor	Eisai Co. Ltd.	2018	20%	Higher efficacy in HCC
Ripretinib	Kinase inhibitor (TKI)	Deciphera Pharmaceuticals	2020	10%	Selectivity for KIT/PDGFRA mutations
TAS-102 (Trifluridine, Tipiracil)	Chemotherapy + enzyme inhibitor	Taiho Pharmaceutical	2015	8%	Different mechanism targeting DNA synthesis

Note: Market shares are estimated based on sales volume and prescribing trends; exact figures are proprietary.

Financial Trajectory and Outlook

1. Revenue Projections (2023-2027)

Year	Estimated Global Revenue (USD billion)	% CAGR	Key Assumptions
2023	0.75	—	Base market, steady repeat sales
2024	0.81	8.0%	Uptake in additional indications, improved market access
2025	0.87	7.4%	Expansion in emerging markets
2026	0.94	8.0%	Introduction of combination therapy approvals
2027	1.02	8.5%	Growing adoption, entry into new therapeutic areas

Note: These projections incorporate potential market expansion, patent expiry impact (if any), and competitive landscape shifts.

2. Pricing and Reimbursement Landscape

Region	Average Wholesale Price (USD per 160 mg tablet)	Reimbursement Policy Impact
US	$150-$200	Insurance coverage, prior authorization constraints
Europe	€130-€180 (~$145-$200)	National reimbursement schemes
Asia-Pacific	$100-$160	Variable, often lower due to generic competition

3. Patent and Regulatory Status

• Patent Life: The original composition patent expired in 2020 in key markets, prompting generic entry.
• Biologics and Biosimilars: Not applicable; regorafenib is a small molecule.
• Regulatory Trends: Accelerated approval pathways and orphan drug designations may influence future approvals.

Comparative Analysis: Key Similar Drugs

Attribute	STIVARGA (Regorafenib)	Lenvatinib	Ripretinib	TAS-102
Indications	mCRC, GIST, HCC	HCC, thyroid cancer	GIST, melanoma	mCRC
Approval Year	2012	2018	2020	2015
Mechanism	Multikinase	VEGFR, FGFR inhibitors	Switch-control kinase	DNA synthesis inhibitor
Approximate Price	$150-200/ tablet	$180-220/ tablet	$200/ tablet	$50/ tablet
Market Share (2022)	50% in mCRC	20% in HCC	10% in GIST	8% in mCRC

Strategic Opportunities and Risks

Opportunities

• Combination Therapies: Trials incorporating regorafenib with immuno-oncology agents (e.g., pembrolizumab) can extend indications.
• Biomarker Development: Personalizing therapy selection could optimize response rates.
• Market Expansion: Growing incidence in Asia and Latin America enhances growth potential.

Risks

• Biosimilar and Generic Competition: Patent expiry impacts pricing power.
• Adverse Event Management: Toxicity constrains dosage and adherence.
• Strategic Shifts: Emergence of novel agents with superior efficacy may displace regorafenib.

Key Regulatory and Policy Trends

Policy Area	Notable Developments
Pricing Regulations	Heightened scrutiny on drug prices in US, EU
Patent Laws	Patent term extensions in some jurisdictions
Approval Pathways	Accelerated pathways for oncology drugs
Reimbursement Policies	Value-based pricing models gaining prominence

Key Takeaways

• Market Maturity: Since its 2012 approval, STIVARGA maintains a significant revenue base but faces aggressive competition and patent cliffs.
• Growth Drivers: Expansion into new indications and combination regimens is essential for sustained growth.
• Pricing Dynamics: Price erosion from biosimilars and generics pressures margins, necessitating cost-effective manufacturing and strategic partnerships.
• Market Opportunities: Asia-Pacific growth and biomarker-driven patient selection present substantial upside potential.
• Strategic Risks: Emergence of next-generation kinase inhibitors or immunotherapies could erode STIVARGA’s market share.

FAQs

1. How does STIVARGA compare to other targeted therapies in oncology?
STIVARGA offers a broad kinase inhibition profile, targeting multiple pathways involved in tumor angiogenesis and growth. Its efficacy varies across indications, but newer agents with higher specificity and better tolerability are emerging, challenging its dominance.

2. What is the outlook for generic versions of regorafenib?
Generic entries are expected following patent expiration, particularly from generic manufacturers in India and China. While they will reduce prices and margins, brand-name compounds may retain market share in premium segments through clinical differentiation and dosing convenience.

3. Are there ongoing trials that could extend STIVARGA’s indications?
Yes. Several phase II and III trials explore regorafenib in other cancers, including biliary tract and ovarian cancers, potentially broadening its therapeutic scope if successful.

4. How might combination therapies affect regorafenib’s market trajectory?
Combining regorafenib with immunotherapies (e.g., checkpoint inhibitors) or other targeted agents can improve efficacy, leading to new approved indications and increased revenue streams.

5. What regulatory strategies could maximize STIVARGA’s longevity?
Secure fast-track approvals, expand indications via accelerated pathways, and invest in biomarker research to personalize therapy and justify premium pricing.

References

1. U.S. Food and Drug Administration. (2012). FDA approves Stivarga for gastrointestinal stromal tumor.
2. IQVIA. (2022). Oncology Market Reports.
3. European Medicines Agency. (2018). Marketing Authorization for Lenvatinib.
4. Deciphera Pharmaceuticals. (2020). Ripretinib approval documentation.
5. Taiho Pharmaceutical. (2015). TAS-102 approval results.

Note: All data are current as of 2022, with projections extending to 2027.

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Disclaimer: This analysis synthesizes current market data and projections; actual future performance may vary based on regulatory, clinical, and economic factors.