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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Julphar
Covington
Daiichi Sankyo
Argus Health
McKesson
Fish and Richardson
Chubb

Generated: April 25, 2018

DrugPatentWatch Database Preview

STIVARGA Drug Profile

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Which patents cover Stivarga, and what generic alternatives are available?

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

This drug has two hundred and thirty-one patent family members in fifty-eight countries.

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.
Summary for STIVARGA
International Patents:231
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 80
Clinical Trials: 43
Patent Applications: 68
Drug Prices:see details
DailyMed Link:STIVARGA at DailyMed
Drug patent expirations by year for STIVARGA
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 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 Submissiondate
➤ Subscribe Tablets 40 mg ➤ Subscribe 2016-09-27

Non-Orange Book US Patents for STIVARGA

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
7,928,239 Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas ➤ Try a Free Trial
8,124,630 .omega.-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors ➤ Try a Free Trial
7,528,255 Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors ➤ Try a Free Trial
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
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for STIVARGA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2006 Austria ➤ Try a Free Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
300 Luxembourg ➤ Try a Free Trial PRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA)
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
2013 00056 Denmark ➤ Try a Free Trial PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
McKesson
AstraZeneca
Colorcon
Teva
Baxter
Moodys
Queensland Health
UBS

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