Regorafenib - Generic Drug Details

What are the generic sources for regorafenib and what is the scope of patent protection?

Regorafenib is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Regorafenib has one hundred and sixty-seven patent family members in forty-eight countries.

There are two drug master file entries for regorafenib. One supplier is listed for this compound.

Summary for regorafenib

International Patents:	167
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	257
Patent Applications:	6,497
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for regorafenib
What excipients (inactive ingredients) are in regorafenib?	regorafenib excipients list
DailyMed Link:	regorafenib at DailyMed

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

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 regorafenib

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

Sponsor	Phase
Peking University	N/A
Xencor, Inc.	Phase 2
Neonc Technologies, Inc.	Phase 1/Phase 2

See all regorafenib clinical trials

Pharmacology for regorafenib

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

Anatomical Therapeutic Chemical (ATC) Classes for regorafenib

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for REGORAFENIB

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

US Patents and Regulatory Information for regorafenib

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			Y	Y
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
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 regorafenib

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 regorafenib

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 regorafenib

Country	Patent Number	Title	Estimated Expiration
Canada	2675980	TRAITEMENT DE CANCERS A RESISTANCE ACQUISE AUX INHIBITEURS KIT (TREATMENT OF CANCERS WITH ACQUIRED RESISTANCE TO KIT INHIBITORS)
Taiwan	I539951
Hong Kong	1200831	-{ }- 製備 -{ -氯- 三氟甲基 苯基 氨基}羰基 氨基 -氟苯氧基}- -甲基吡啶- -羧酰胺、其鹽和水合物的方法 (A PROCESS FOR PREPARING 4-4-[([4-CHLORO-3-(TRIFLUOROMETHYL) PHENYL]AMINOCARBONYL)AMINO]-3-FLUOROPHENOXY-N-METHYLPYRIDINE-2- CARBOXAMIDE, ITS SALTS AND MONOHYDRATE 4-4-[([4--3-()])]-3--N- -2-)
Australia	2013200394	Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions
Japan	2008542214

Supplementary Protection Certificates for regorafenib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663978	C01663978/01	Switzerland		FORMER OWNER: BAYER HEALTHCARE LLC, US
1663978	13C0060	France		PRODUCT NAME: REGORAFENIB ET SES SELS; REGISTRATION NO/DATE: EU/1/13/858/001-002 20130829
1663978	CR 2013 00056	Denmark		PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826
1663978	56/2013	Austria		PRODUCT NAME: REGORAFENIB UND SEINE SALZE; REGISTRATION NO/DATE: EU/1/13/858 (MITTEILUNG) 20130829
1663978	2013C/067	Belgium		PRODUCT NAME: STIVARGA-REGORAFENIB; AUTHORISATION NUMBER AND DATE: EU/1/13/858 20130829

Regorafenib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Regorafenib

Introduction to Regorafenib

Regorafenib is a multi-kinase inhibitor used in the treatment of various types of cancer, including metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), and gastrointestinal stromal tumors (GIST). Here, we delve into the market dynamics and financial trajectory of regorafenib, highlighting its current market size, growth prospects, regional performance, and cost-effectiveness.

Global Market Size and Growth Prospects

As of 2024, the global regorafenib market size is estimated at USD 1,558.5 million. This market is projected to grow at a compound annual growth rate (CAGR) of 11% from 2024 to 2031[1].

Regional Market Performance

North America

North America dominates the global regorafenib market, accounting for more than 40% of the global revenue 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, driven by factors such as increasing incidences of colorectal cancer and HCC, favorable reimbursement policies, and expanding healthcare infrastructure[1].

Europe

Europe holds around 30% of the global revenue, with a market size of USD 467.55 million in 2024. The European market is anticipated to grow at a CAGR of 9.5% from 2024 to 2031. Countries like Germany, the UK, and France are key contributors, driven by the increasing adoption of targeted therapies and precision medicine approaches[1].

Asia Pacific

The Asia Pacific region accounts for approximately 23% of the global revenue, with a market size of USD 358.46 million in 2024. This region is expected to grow at a CAGR of 13% from 2024 to 2031, driven by increasing healthcare infrastructure and expanding access to innovative treatments. China, Japan, South Korea, and India are significant contributors to this growth[1].

Middle East and Africa

The Middle East and Africa (MEA) region holds a smaller but growing market share, accounting for around 2% of the global revenue with a market size of USD 31.17 million in 2024. The MEA market is projected to grow at a CAGR of 10.7% from 2024 to 2031, driven by expanding indications, increasing access to innovative treatments, and improving healthcare infrastructure[1].

Cost-Effectiveness and Pricing

Standard Dose Cost-Effectiveness

The standard dose of regorafenib is not considered cost-effective in the treatment of metastatic colorectal cancer when compared to other third-line treatments. A study published in Cancer Management and Research found that regorafenib had minimal incremental benefit at a high incremental cost per quality-adjusted life year (QALY). At a willingness-to-pay (WTP) threshold of $900,000 per QALY, there was only a 50% chance of cost-effectiveness for regorafenib. When compared to best supportive care, regorafenib was not cost-effective at a WTP threshold of $27,576[2].

Comparative Cost-Effectiveness

Regorafenib is less cost-effective than other treatments such as trifluridine/tipiracil (TAS-102) and fruquintinib. For instance, TAS-102 combined with bevacizumab was found to be less cost-effective than optimized dosing of regorafenib, but overall, regorafenib was less clinically and cost-effective compared to TAS-102 in several studies. Fruquintinib, on the other hand, offered an increase of 0.05 QALYs with a cost savings of $11,454 compared to regorafenib[2].

Dose Escalation Strategy

A dose escalation strategy for regorafenib could potentially improve its cost-effectiveness. This approach has been suggested as a way to enhance the therapeutic benefits while managing the costs associated with the treatment[2].

Market Trends and Drivers

Increasing Incidences of Cancer

The rising incidences of colorectal cancer and hepatocellular carcinoma are significant drivers of the regorafenib market. For example, in the United States, CRC led to approximately 51,869 deaths in 2020, making it a prominent cause of cancer-related deaths[2].

Advancements in Precision Medicine

The increasing adoption of targeted therapies and precision medicine approaches is another key driver. Regions like North America and Europe are witnessing significant growth due to these advancements, which enhance the efficacy and personalized treatment options for patients[1].

Expanding Healthcare Infrastructure

Improving healthcare infrastructure, especially in the Asia Pacific region, is facilitating greater access to innovative treatments like regorafenib. This expansion is crucial for the market's growth prospects[1].

Regulatory Approvals and Collaborations

Regulatory approvals and strategic collaborations are also driving the market. For instance, approvals for various cancer indications and collaborations between pharmaceutical companies are enhancing market penetration and growth[1].

Competitive Landscape

Emerging Therapies

The regorafenib market faces competition from emerging therapies for glioblastoma multiforme (GBM) and other cancer types. These new therapies are expected to challenge regorafenib's dominance and impact its market share in the coming years[4].

Market Competitors

Companies are developing novel approaches to treat cancer, which could influence the market dynamics. The competitive landscape includes other multi-kinase inhibitors and targeted therapies that are being evaluated for their efficacy and cost-effectiveness[4].

Future Market Assessments

Forecasted Sales Data

The forecasted sales data for regorafenib from 2023 to 2032 indicates a growing market. The detailed analysis of sales data in key markets such as the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan will help in understanding the overall market scenario and making informed decisions regarding therapeutic portfolios[4].

SWOT Analysis

A SWOT analysis highlights the strengths, weaknesses, opportunities, and threats for regorafenib. The strengths include its established efficacy and accessibility, while the weaknesses include its high cost and limited cost-effectiveness. Opportunities lie in expanding indications and improving healthcare infrastructure, while threats come from emerging therapies and competitive market dynamics[4].

Key Takeaways

• Global Market Growth: The global regorafenib market is projected to grow at a CAGR of 11% from 2024 to 2031.
• Regional Performance: North America, Europe, and the Asia Pacific are key regions driving market growth.
• Cost-Effectiveness: Regorafenib's standard dose is not cost-effective compared to other treatments; a dose escalation strategy may improve its cost-effectiveness.
• Market Drivers: Increasing cancer incidences, advancements in precision medicine, and expanding healthcare infrastructure are significant drivers.
• Competitive Landscape: Emerging therapies and market competitors pose challenges to regorafenib's market share.

FAQs

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

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 global regorafenib market from 2024 to 2031?

The global regorafenib market is projected to grow at a CAGR of 11% from 2024 to 2031[1].

Q: Which region dominates the regorafenib market?

North America dominates the global regorafenib market, accounting for more than 40% of the global revenue[1].

Q: Is regorafenib cost-effective in the treatment of metastatic colorectal cancer?

Regorafenib is not considered cost-effective at standard doses compared to other third-line treatments for metastatic colorectal cancer[2].

Q: What are the key drivers of the regorafenib market?

Key drivers include increasing incidences of cancer, advancements in precision medicine, and expanding healthcare infrastructure[1].

Sources

1. Cognitive Market Research: Regorafenib Market Report.
2. AJMC: Standard Dose of Regorafenib Not Cost-Effective in CRC.
3. News Channel Nebraska: Regorafenib Market Size, Share and Forecast to 2032.
4. Research and Markets: Regorafenib Drug Insight and Market Forecast - 2032.
5. PubMed: Cost-effectiveness Analysis of Regorafenib and TAS-102.