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Last Updated: April 18, 2024

REGORAFENIB - Generic Drug Details

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What are the generic sources for regorafenib and what is the scope of freedom to operate?

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:	249
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

Generic Entry Date for REGORAFENIB^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
Xencor, Inc.	Phase 2
Beijing Tsinghua Changgeng Hospital	Phase 2
Shenyang Tenth People's Hospital	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

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

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Glossary

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

Expired US Patents for REGORAFENIB

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

EU/EMA Drug Approvals for REGORAFENIB

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for REGORAFENIB

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2009117388	МОНОГИДРАТ 4-[4-({[4-ХЛОР-3-(ТРИФТОРМЕТИЛ)ФЕНИЛ]КАРБАМОИЛ})АМИНО)-3-ФТОРФЕНОКСИ]-N-МЕТИЛПИРИДИН-2-КАРБОКСАМИДА	⤷ Try a Trial
Australia	2011201337	Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions	⤷ Try a Trial
Spain	2297490		⤷ Try a Trial
Singapore	10201501221U	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	⤷ Try a Trial
Japan	5346293		⤷ Try a Trial
Morocco	34156	PROCÉDÉDEPRÉPARATIONDE 4-{4-[({[4-CHLORO-3-(TRIFLUOROMÉTHYL)-PHÉNYL]AMINO}CARBONYL)AMINO]-3-FLUOROPHÉNOXY}-N-ÉTHYLPYRIDINE	⤷ Try a Trial
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	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for REGORAFENIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663978	CR 2013 00056	Denmark	⤷ Try a Trial	PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826
1663978	C300620	Netherlands	⤷ Try a Trial	PRODUCT NAME: REGORAFENIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/858 20130826
1663978	SPC/GB13/076	United Kingdom	⤷ Try a Trial	PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTERED: UK EU/1/13/858/001 20130829; UK EU/1/13/858/002 20130829
1663978	2013/050	Ireland	⤷ Try a Trial	PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826
1663978	1390050-1	Sweden	⤷ Try a Trial	PRODUCT NAME: REGORAFENIB; PERIOD OF VALIDITY (FROM - UNTIL): 2024-07-23 - 2028-08-28
1663978	C01663978/01	Switzerland	⤷ Try a Trial	FORMER OWNER: BAYER HEALTHCARE LLC, US
1663978	149 13-2013	Slovakia	⤷ Try a Trial	FIRST REGISTRATION NO/DATE: EU/1/13/858, 20130826
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.