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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-seven patent family members in forty-eight 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 8, 2031. This may change due to patent challenges or generic licensing.

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:	167
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	82
Patent Applications:	2,287
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for STIVARGA

Constraining patent/regulatory exclusivity:

9,458,107

NDA:

203085

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for STIVARGA

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

Sponsor	Phase
Great Novel Therapeutics Biotech & Medicals Corporation	Phase 1/Phase 2
The First Affiliated Hospital of Dalian Medical University	Phase 1/Phase 2
University of Miami	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 and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,458,107.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes	9,957,232			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	7,351,834

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/002573 Stivarga 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

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
Japan	2002534468
South Africa	200600609	Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions
Canada	2666170	4-[4-({[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]CARBAMOYL}AMINO)-3-FLUOROPHENOXY]-N-METHYLPYRIDINE-2-CARBOXAMIDE MONOHYDRATE (4-[4-({[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]CARBAMOYL}AMINO)-3-FLUOROPHENOXY]-N-METHYLPYRIDINE-2-CARBOXAMIDE MONOHYDRATE)
Slovenia	1690853

Supplementary Protection Certificates for STIVARGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140840	295	Finland
1140840	35/2006	Austria		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1663978	C01663978/01	Switzerland		FORMER OWNER: BAYER HEALTHCARE LLC, US
1663978	2013/050	Ireland		PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826

STIVARGA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for STIVARGA (Regorafenib)

Overview of STIVARGA (Regorafenib)

STIVARGA, also known as regorafenib, is a multi-kinase inhibitor developed by Bayer, used primarily in the treatment of various types of cancer, including metastatic colorectal cancer (mCRC), gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma (HCC)[2][4].

Global Market Size and Growth

As of 2024, the global regorafenib market size is estimated at USD 1,558.5 million. This market is projected to expand at a compound annual growth rate (CAGR) of 11.00% from 2024 to 2031. This significant growth is driven by increasing incidences of colorectal cancer and HCC, along with advancements in precision medicine[1].

Regional Market Analysis

North America

North America holds the largest share of the global regorafenib market, with a market size of USD 623.4 million in 2024. The region is expected to grow at a CAGR of 9.2% from 2024 to 2031. The United States and Canada are the primary contributors to this growth, driven by favorable reimbursement policies and expanding healthcare infrastructure[1].

Europe

The European market for regorafenib is substantial, with a market size of USD 467.55 million in 2024. It is expected to grow at a CAGR of 9.5% from 2024 to 2031. The growth in Europe is fueled by increasing cancer incidence rates and the adoption of targeted therapies[1].

Asia Pacific

The Asia Pacific region shows promising growth, with a market size of USD 358.46 million in 2024 and a projected CAGR of 13% from 2024 to 2031. This rapid growth is driven by increasing access to innovative treatments and strategic collaborations in countries like China, where STIVARGA was launched in 2018 and achieved significant sales[1][4].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also present growth opportunities, with market sizes of USD 77.93 million and USD 31.17 million in 2024, respectively. These regions are expected to grow at CAGRs of 10.4% and 10.7% from 2024 to 2031, driven by rising cancer incidence rates and improving healthcare infrastructure[1].

Financial Performance of STIVARGA

Historical Sales

In 2020, STIVARGA achieved global sales of 475 million euros, marking two consecutive years of greater than 15% year-over-year growth. This growth was consistent across all markets, including a notable performance in China where STIVARGA achieved approximately 100 million euros in annualized sales by 2020[4].

Future Growth Potential

STIVARGA is positioned for continued growth due to its multiple indications and potential in combination therapies. For instance, the drug has shown promising results in combination with PD-1 inhibitors in gastric cancer and glioblastoma, which are being confirmed in phase III trials. This expansion into new therapeutic areas and combinations is expected to drive further growth[4].

Clinical and Market Strategies

Precision Medicine

Bayer's strategy in oncology, including STIVARGA, is heavily focused on precision medicine. The drug's efficacy in targeted therapies for specific patient populations, such as those with mCRC, GIST, and HCC, aligns with this strategy. The company is also investing in research and development to identify new indications and combinations that can further enhance STIVARGA's market position[4].

Combination Therapies

STIVARGA is being evaluated in combination with other drugs, such as nivolumab (Opdivo), to treat metastatic colorectal cancer. These clinical collaborations aim to enhance treatment outcomes and expand the drug's market potential[2].

Financial Support and Access Programs

To improve patient access, Bayer offers financial support programs, including a $0 co-pay program for eligible patients. Such initiatives help in increasing the drug's adoption and market penetration[5].

Challenges and Risks

Adverse Reactions

STIVARGA is associated with several adverse reactions, including severe drug-induced liver injury, infections, hemorrhage, gastrointestinal perforation or fistula, hypertension, and cardiac ischemia. These side effects necessitate careful patient monitoring and management, which can impact the drug's adoption and patient compliance[2].

Competitive Landscape

The oncology market is highly competitive, with numerous drugs and therapies available. STIVARGA must compete with other targeted therapies and combination treatments, which can affect its market share and growth trajectory.

Key Takeaways

• Global Market Growth: The global regorafenib market is expected to grow at a CAGR of 11.00% from 2024 to 2031.
• Regional Dominance: North America holds the largest market share, followed by Europe and Asia Pacific.
• Financial Performance: STIVARGA achieved significant sales in 2020 and is expected to continue growing due to its multiple indications and potential in combination therapies.
• Precision Medicine: Bayer's focus on precision medicine aligns with STIVARGA's targeted therapy approach.
• Combination Therapies: Ongoing clinical collaborations to evaluate STIVARGA in combination with other drugs aim to enhance treatment outcomes.
• Adverse Reactions: Careful patient monitoring is necessary due to the drug's associated adverse reactions.

FAQs

Q: What is the current global market size for regorafenib?

A: The global regorafenib market size is estimated at USD 1,558.5 million as of 2024[1].

Q: What is the projected CAGR for the regorafenib market from 2024 to 2031?

A: The regorafenib market is projected to grow at a CAGR of 11.00% from 2024 to 2031[1].

Q: Which regions are the primary contributors to the growth of the regorafenib market?

A: North America, Europe, and Asia Pacific are the primary regions driving the growth of the regorafenib market[1].

Q: What are the main indications for STIVARGA?

A: STIVARGA is primarily used in the treatment of metastatic colorectal cancer (mCRC), gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma (HCC)[2][4].

Q: What are some of the significant adverse reactions associated with STIVARGA?

A: STIVARGA is associated with severe drug-induced liver injury, infections, hemorrhage, gastrointestinal perforation or fistula, hypertension, and cardiac ischemia[2].

Sources

1. Cognitive Market Research: Regorafenib Market Report.
2. Bristol-Myers Squibb: Bayer, Bristol-Myers Squibb and Ono Pharmaceutical Enter Into a Clinical Collaboration Agreement.
3. ASPE: Antimicrobial Drugs Market Returns Analysis.
4. Bayer: Capital Markets Day 2021 Transcript.
5. Bayer: Oncology $0 Co-Pay Program - STIVARGA® (regorafenib).