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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Federal Trade Commission
Argus Health
QuintilesIMS
McKinsey
Moodys
Queensland Health
Deloitte

Generated: June 24, 2018

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 regorafenib 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 patent family members in fifty-eight countries.

There are two drug master file entries for regorafenib. One supplier is listed for this compound.
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
AJ-56815
AK106990
AKOS015951107
AM81251
anhydrous regorafenib
AOB87754
AS-16304
AX8232295
BAY 73-4506
BAY 734506
BAY-73-4506
BAY-734506 monohydrate
BAY73-4506
BAY73-4506 hydrochloride
BAY73-4506(Regorafenib)/
BCP9000384
BCPP000352
BDBM50363397
C21H15ClF4N4O3
cas:835621-07-3;Regorafenib hydrochloride
CHEBI:68647
CHEMBL1946170
CJ-13100
CS-0170
D09GDD
D10138
DB08896
DTXSID60226441
EX-A058
FNHKPVJBJVTLMP-UHFFFAOYSA-N
FT-0674338
GTPL5891
HE070021
HE386186
HMS3654K16
HY-10331
KB-80344
KS-00000Q4Q
MFCD16038047
MLS006010303
MolPort-009-679-472
NCGC00263138-01
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
SC-28977
SCHEMBL432230
SMR004701370
SR-01000941571
SR-01000941571-1
ST24023156
Stivarga
Stivarga (TN)
SYN1169
UNII-24T2A1DOYB
ZINC6745272

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for regorafenib

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,748,622 Process for the preparation of 4-{4[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluor- ophenoxy}-N-methylpyridine-2-carboxamide, its salts and monohydrate ➤ Try a Free Trial
7,528,255 Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors ➤ Try a Free Trial
7,897,623 .omega.-carboxyl aryl substituted diphenyl ureas as p38 kinase inhibitors ➤ Try a Free Trial
7,928,239 Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for regorafenib

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006008,C1140840 Lithuania ➤ Try a Free Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
2006 008, C 1140840 Lithuania ➤ Try a Free Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
2013 00056 Denmark ➤ Try a Free Trial PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826
0130034 00099 Estonia ➤ Try a Free Trial PRODUCT NAME: REGORAFENIIB;REG NO/DATE: K(2013)5622 (LOPLIK) 26.08.2013
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Cerilliant
Daiichi Sankyo
Mallinckrodt
Federal Trade Commission
Citi
Chubb
Fuji

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 verifification 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.