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Last Updated: May 31, 2020

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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.

This drug has two hundred and seventy-seven 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.

US ANDA Litigation and Generic Entry Outlook for Stivarga

Stivarga was eligible for patent challenges on September 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 8, 2031. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for STIVARGA
Drug Prices for STIVARGA

See drug prices 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.

Recent Clinical Trials for STIVARGA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Wake Forest University Health SciencesPhase 2
Centre Leon BerardN/A
The First People's Hospital of JingzhouPhase 1/Phase 2

See all STIVARGA clinical trials

Recent Litigation for STIVARGA

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 STIVARGA litigation

PTAB Litigation
PetitionerDate
Fustibal LLC2016-07-25
2015-11-09

See all STIVARGA litigation

Pharmacology for STIVARGA
Synonyms for STIVARGA
1255386-16-3
2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]-3-fluorophenoxy]-N-methyl-
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-(trifluoromethy)phenyl]carbamoyl}amino)-3-fluorophenoxy]-1-methylpyridine-2-carboxamide
4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide
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
AK106990
AKOS015951107
AM81251
AOB87754
AS-16304
AX8232295
BAY 73-4506
BAY 734506
BAY-73-4506
Bay-734506
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
CS-0170
D10138
DB08896
DTXSID60226441
EX-A058
Fluoro-Sorafenib
FNHKPVJBJVTLMP-UHFFFAOYSA-N
FT-0674338
GTPL5891
HMS3654K16
HY-10331
KS-00000Q4Q
MLS006010303
NCGC00263138-01
NCGC00263138-13
Q3891664
QCR-85
R0142
Regorafenib
Regorafenib - BAY 73-4506
Regorafenib (BAY 73-4506)
Regorafenib (BAY73-4506 Fluoro-Sorafenib)
Regorafenib (USAN/INN)
Regorafenib [USAN:INN]
Regorafenib crystalline form I
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
S-7780
s1178
SB16819
SC-28977
SCHEMBL432230
SMR004701370
SR-01000941571
SR-01000941571-1
ST24023156
Stivarga (TN)
SW218097-2
SYN1169
UNII-24T2A1DOYB
ZINC6745272
Paragraph IV (Patent) Challenges for STIVARGA
Tradename Dosage Ingredient NDA Submissiondate
STIVARGA TABLET;ORAL regorafenib 203085 2016-09-27

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   Start Trial   Start Trial   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 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
>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 STIVARGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663978 SPC/GB13/076 United Kingdom   Start Trial PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTERED: UK EU/1/13/858/001 20130829; UK EU/1/13/858/002 20130829
1140840 SPC 031/2006 Ireland   Start Trial SPC 031/2006: 20070528, EXPIRES: 20210718
1140840 122006000059 Germany   Start Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 SPC/GB07/004 United Kingdom   Start Trial PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1140840 CA 2007 00002 Denmark   Start Trial PRODUCT NAME: SORAFENIB TOSYLAT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Boehringer Ingelheim
McKinsey
Moodys
Dow

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.