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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Cantor Fitzgerald
Teva
QuintilesIMS
Johnson and Johnson
Moodys
US Department of Justice
Queensland Health
Harvard Business School

Generated: October 22, 2018

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STIVARGA Drug Profile

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When do Stivarga patents expire, and when can generic versions of Stivarga launch?

Stivarga is a drug marketed by Bayer Hlthcare and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in STIVARGA is regorafenib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the regorafenib profile page.

Drug patent expirations by year for STIVARGA
Generic Entry Opportunity Date for STIVARGA
Generic Entry Date for STIVARGA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for STIVARGA
Synonyms for STIVARGA
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
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 (TN)
SYN1169
UNII-24T2A1DOYB
ZINC6745272

US Patents and Regulatory Information for STIVARGA

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 ➤ 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 ➤ 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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Paragraph IV (Patent) Challenges for STIVARGA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 40 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for STIVARGA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2007 00002 Denmark ➤ Try a Free Trial PRODUCT NAME: SORAFENIB TOSYLAT
90050-1 Sweden ➤ Try a Free Trial PRODUCT NAME: REGORAFENIB
5 Finland ➤ Try a Free Trial
/2006 Austria ➤ Try a Free Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
2006000059 Germany ➤ Try a Free Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Cantor Fitzgerald
Teva
QuintilesIMS
Johnson and Johnson
Moodys
US Department of Justice
Queensland Health
Harvard Business School

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.