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Last Updated: March 6, 2021

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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 seventy-eight 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
International Patents:278
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Suppliers / Packagers: 1
Bulk Api Vendors: 103
Clinical Trials: 181
Patent Applications: 2,406
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
Recent Clinical Trials for regorafenib

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

SponsorPhase
Arcus Biosciences, Inc.Phase 1/Phase 2
Bristol Myers Squibb Co. and Ono Pharmaceutical Co., LtdPhase 2
Jieyang People's HospitalPhase 2

See all regorafenib clinical trials

Pharmacology for regorafenib
Paragraph IV (Patent) Challenges for REGORAFENIB
Tradename Dosage Ingredient NDA Submissiondate
STIVARGA TABLET;ORAL regorafenib 203085 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   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for regorafenib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 35/2006 Austria   Start Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1663978 CA 2013 00056 Denmark   Start Trial PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826
1663978 2013/050 Ireland   Start Trial PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826
1140840 91280 Luxembourg   Start Trial 91280, EXPIRES: 20210720
1140840 06C0034 France   Start Trial 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
1140840 SPC/GB07/004 United Kingdom   Start Trial PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1663978 56/2013 Austria   Start Trial PRODUCT NAME: REGORAFENIB UND SEINE SALZE; REGISTRATION NO/DATE: EU/1/13/858 (MITTEILUNG) 20130829
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
McKinsey
Mallinckrodt
AstraZeneca
Boehringer Ingelheim

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