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Last Updated: December 7, 2022

Regorafenib - Generic Drug Details


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What are the generic drug 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 five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Regorafenib has two hundred and eighty-one patent family members in fifty-eight countries.

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

Summary for regorafenib
Recent Clinical Trials for regorafenib

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

SponsorPhase
Centre Hospitalier Universitaire de BesanconPhase 2/Phase 3
Shenzhen Chipscreen Biosciences Co.LtdPhase 2
Benxi Cental HospitalPhase 1/Phase 2

See all regorafenib clinical trials

Pharmacology for regorafenib
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

International Patents for regorafenib

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2005009961 See Plans and Pricing
Dominican Republic P2012000268 PROCEDIMIENTO PARA LA PREPARACION DE 4-{4-[({[4-CLORO-3-(TRIFLUOROMETIL) FENIL]ANIMO}CARBONIL)AMINO]-3-FLUOROFENOXI}-N-METILPIRIDINA-2-CARBOXAMIDA, SUS SALES Y SU MONOHIDRATO See Plans and Pricing
Montenegro 00275 ω-KARBOKSIARIL SUPSTITUISANI DIFENIL KARBAMIDI KAO INHIBITORI RAF KINAZE (?-CARBOXYARYL SUBSTITUTED DIPHENYL UREAS AS RAF KINASE INHIBITORS) See Plans and Pricing
Israel 144030 OMEGA- CARBOXYARYL SUBSTITUTED DIPHENYL UREAS, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM AND THEIR USE FOR THE PREPARATION OF MEDICAMENTS FOR INHIBITING RAF KINASE See Plans and Pricing
European Patent Office 1379507 UREES HETEROARYLES CONTENANT DES HETERO-ATOMES D'AZOTE COMME INHIBITEURS DE KINASE P38 (HETEROARYL UREAS CONTAINING NITROGEN HETERO-ATOMS AS p38 KINASE INHIBITORS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for regorafenib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663978 122013000086 Germany See Plans and Pricing PRODUCT NAME: REGORAFENIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/858 20130826
1663978 1390050-1 Sweden See Plans and Pricing PRODUCT NAME: REGORAFENIB; PERIOD OF VALIDITY (FROM - UNTIL): 2024-07-23 - 2028-08-28
1663978 C300620 Netherlands See Plans and Pricing PRODUCT NAME: REGORAFENIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/858 20130826
1140840 SPC/GB07/004 United Kingdom See Plans and Pricing PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1140840 295 Finland See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
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AstraZeneca
Boehringer Ingelheim

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