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Last Updated: November 25, 2024

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 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for regorafenib
Generic Entry Date for regorafenib*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Peking UniversityN/A
Xencor, Inc.Phase 2
Neonc Technologies, Inc.Phase 1/Phase 2

See all regorafenib clinical trials

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
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 ⤷  Sign Up
Chile 2007002930 UN COMPUESTO 4-[4-({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]CARBAMOIL}AMINO)-3-FLUOROFENOXI]-N-METILPIRIDIN-2-CARBOXAMIDA MONOHIDRATADO; PROCESO DE PREPARACION; COMPOSICION Y COMBINACION FARMACEUTICA; Y USO PARA EL TRATAMIENTO DE TRASTORNOS HIPERPROLIFERATI ⤷  Sign Up
China 102947271 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 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for regorafenib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2097381 C02097381/01 Switzerland ⤷  Sign Up PRODUCT NAME: REGORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62808 15.03.2018
1663978 149 13-2013 Slovakia ⤷  Sign Up FIRST REGISTRATION NO/DATE: EU/1/13/858, 20130826
1663978 92300 Luxembourg ⤷  Sign Up PRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA)
>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.