Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Express Scripts
Harvard Business School
Moodys
Boehringer Ingelheim

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Regorafenib - Generic Drug Details

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What are the generic drug 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-four 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
Centre Leon BerardN/A
Eastern Hepatobiliary Surgery HospitalPhase 2
West China HospitalPhase 2

See all regorafenib clinical trials

Recent Litigation for regorafenib

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bayer Healthcare LLC v. Apotex, Inc.2018-09-21
Bayer Healthcare LLC v. Apotex Inc.2016-12-16
Bayer Healthcare LLC v. Apotex, Inc.2016-12-16

See all regorafenib litigation

PTAB Litigation
PetitionerDate
Fustibal LLC2016-07-25

See all regorafenib litigation

Pharmacology for regorafenib
Synonyms for regorafenib
2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]-3-fluorophenoxy]-N-methyl-
24T2A1DOYB
4-(4-(((4-chloro-3-(trifluoromethyl)phenyl)carbamoyl}amino)-3-fluorophenoxy)-N-methylpyridine-2-carboxamide
4-(4-(3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido)-3-fluorophenoxy)-N-methylpicolinamide
4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide
4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]-3-fluoro-phenoxy]-N-methyl-pyridine-2-carboxamide
4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]-3-fluorophenoxy]-N-methylpyridine-2-carbox
4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]-3-fluorophenoxy]-N-methylpyridine-2-carboxamide
4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide
4CA-1083
755037-03-7
835621-08-4
A25020
AB0008044
AB01565826_02
AB1008457
ABP000611
AC-25075
ACN-036634
AJ-56815
AKOS015951107
AM81251
AOB87754
AS-16304
AX8232295
BAY 73-4506
BAY 73-4506; Stivarga
BAY 734506
BAY-73-4506
BAY-734506 monohydrate
BAY73-4506
BAY73-4506 hydrochloride
BAY73-4506(Regorafenib)/
BCP02105
BCP9000384
BCPP000352
BDBM50363397
BRD-K16730910-001-02-4
C21H15ClF4N4O3
cas:835621-07-3;Regorafenib hydrochloride
CHEBI:68647
CHEMBL1946170
CJ-13100
CS-0170
D10138
DB08896
DTXSID60226441
EX-A058
FNHKPVJBJVTLMP-UHFFFAOYSA-N
FT-0674338
GTPL5891
HMS3654K16
HY-10331
KB-80344
KS-00000Q4Q
MLS006010303
MolPort-009-679-472
NCGC00263138-01
NCGC00263138-13
QCR-85
R0142
Regorafenib - BAY 73-4506
Regorafenib (BAY 73-4506)
Regorafenib (BAY73-4506 Fluoro-Sorafenib)
Regorafenib (USAN/INN)
Regorafenib [USAN:INN]
Regorafenib, 755037-03-7
Regorafenib,BAY 73-4506
Regorafenib;1-(4-chloro-3-(trifluoromethyl)phenyl)-3-(2-fluoro-4-(2-(methylcarbamoyl)pyridin-4-yloxy)phenyl)urea
Regorafenib(BAY 73-4506)
RegorafenibBAY73-4506
Regorafenibum
RL04875
S-7780
s1178
SB16819
SC-28977
SCHEMBL432230
SMR004701370
SR-01000941571
SR-01000941571-1
ST24023156
Stivarga
Stivarga (TN)
SW218097-2
SYN1169
UNII-24T2A1DOYB
ZINC6745272
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 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 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 Y   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 2013/050 Ireland   Start Trial PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826
1663978 56/2013 Austria   Start Trial PRODUCT NAME: REGORAFENIB UND SEINE SALZE; REGISTRATION NO/DATE: EU/1/13/858 (MITTEILUNG) 20130829
1663978 149 13-2013 Slovakia   Start Trial FIRST REGISTRATION NO/DATE: EU/1/13/858, 20130826
1663978 475 Finland   Start Trial
1663978 122013000086 Germany   Start Trial PRODUCT NAME: REGORAFENIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/858 20130826
1140840 PA2006008 Lithuania   Start Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Boehringer Ingelheim
McKinsey
Baxter
Merck

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