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Last Updated: November 24, 2020

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Regorafenib - Generic Drug Details

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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 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.

Recent Clinical Trials for regorafenib

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

SponsorPhase
China Medical University HospitalPhase 4
Centre Hospitalier Universitaire de BesanconPhase 2
China Medical University, ChinaPhase 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   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
1663978 92300 Luxembourg   Start Trial PRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA)
1140840 122006000059 Germany   Start Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1663978 C300620 Netherlands   Start Trial PRODUCT NAME: REGORAFENIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/858 20130826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Baxter
Express Scripts
Medtronic
McKinsey

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