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Last Updated: November 13, 2019

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NEXAVAR Drug Profile

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When do Nexavar patents expire, and what generic alternatives are available?

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

This drug has two hundred and thirteen patent family members in fifty-six countries.

The generic ingredient in NEXAVAR is sorafenib tosylate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sorafenib tosylate profile page.

Drug patent expirations by year for NEXAVAR
Drug Prices for NEXAVAR

See drug prices for NEXAVAR

Generic Entry Opportunity Date for NEXAVAR
Generic Entry Date for NEXAVAR*:
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 NEXAVAR

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

SponsorPhase
Yiviva Inc.Phase 2
Institut du Cancer de Montpellier - Val d'AurellePhase 3
Samyang Biopharmaceuticals CorporationPhase 1

See all NEXAVAR clinical trials

Recent Litigation for NEXAVAR

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bayer Healthcare LLC v. Apotex Inc.2016-12-16
Bayer Healthcare LLC v. Teva Pharamaceuticals USA, Inc.2016-12-16
Bayer Healthcare LLC v. Mylan Pharmaceuticals Inc.2015-12-17

See all NEXAVAR litigation

Pharmacology for NEXAVAR
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for NEXAVAR
100012-18-8
15216-EP2272827A1
15216-EP2298778A1
15216-EP2311840A1
15216-EP2316832A1
15216-EP2316833A1
1uwh
2-Pyridinecarboxamide, 4-(4-((((4-chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-
2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-
284461-73-0
3gcs
3heg
4-(4-((((4-Chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-2-pyridinecarboxamide
4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl) ureido) phenoxy)-N-methylpicolinamide
4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl) ureido)phenoxy)-N-methylpicolinamide
4-(4-(3-(4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL)UREIDO)PHENOXY)-N-METHYLPICOLINAMIDE
4-(4-(3-(4-chloro-3-trifluoromethylphenyl)ureido)phenoxy)pyridine-2-carboxyllic acid methyamide-4-methylbenzenesulfonate
4-(4-{3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido}phenoxy)-N(sup 2)-methylpyridine-2-carboxamide
4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N2-methylpyridine-2-carboxamide
4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide
4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide
4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methyl-picolinamide;tosylic acid
4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methyl-pyridine-2-carboxamide
4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide
4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)-amino]phenoxy}-N-methylpyridine-2-carboxamide
4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)amino]phenoxy}-N-methyl-pyridine-2-carboxamide
4-{4-[({[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]AMINO}CARBONYL)AMINO]PHENOXY}-N-METHYLPYRIDINE-2-CARBOXAMIDE
4(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N(sup 2)-methylpyridine-2-carboxamide
461S730
4asd
9ZOQ3TZI87
AB0019677
AB00933189_08
AB00933189-05
AB00933189-06
AB1004622
AC-1674
AC1L50CF
ACN-032355
ACT06732
AKOS005560229
AM20090614
AN-613
AOB87782
BAX
BAY 43-9006
BAY 439006
BAY-43-0006
BAY-43-9006
BAY-54-9085
BAY43-9006
BAY439006
BC679588
BCP01767
BCPP000064
BDBM16673
BRD-K23984367-001-01-8
CHEBI:50924
CHEMBL1336
cid_216239
CS-1590
CS0056
D08524
DB00398
DTXSID7041128
EC 608-209-4
EN002709
FT-0650736
GTPL5711
Hit compound, 8
HMS2043A18
HMS3244A15
HMS3244A16
HMS3244B15
HMS3656N20
HSDB 8173
HY-10201
I06-0856
J10391
K00597a
KB-60586
KB-80670
Kinome_766
KS-0000009E
LS-186067
LS-187021
LS-187788
MCULE-6112506696
MFCD06411450
MLDQJTXFUGDVEO-UHFFFAOYSA-N
MolPort-003-850-270
N-(3-trifluoromethyl-4-chlorophenyl)-N'-(4-(2-methylcarbamoyl pyridin-4-yl)oxyphenyl)urea
N-(4-chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcar bamoyl)-4-pyridyloxy)phenyl)urea
N-(4-chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl) urea
N-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea
N-[4-Chloro-3-(trifluoromethyl)phenyl]-N'-[4-[2-(N-methylcarbamoyl)-4-pyridyloxy]phenyl]urea; 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide
NCGC00167488-01
NCGC00167488-02
NCGC00167488-03
NCGC00167488-04
NCGC00167488-05
NCGC00167488-07
NCGC00167488-14
Nexavar (TN) (Bayer)
Nexavar|||BAY 43-9006
NSC-724772
NSC-747971
NSC747971
PB14443
Q-201728
QCR-65
RS0103
s7397
SB19942
SC-19355
SCHEMBL8218
SF-0529
Sorafenib
Sorafenib (Nexavar)
Sorafenib (USAN/INN)
Sorafenib [INN]
Sorafenib [USAN:INN:BAN]
SORAFENIB BASE
Sorafenib free base (BAY-43-9006)
Sorafenib-d3
Sorafenib, 4
sorafenibum
Sorafinib
SR-00000000529
SR-00000000529-1
STK627350
SW202562-4
SYN1082
UNII-9ZOQ3TZI87
Z89277543
ZINC1493878
Paragraph IV (Patent) Challenges for NEXAVAR
Tradename Dosage Ingredient NDA Submissiondate
NEXAVAR TABLET;ORAL sorafenib tosylate 021923 2014-02-28

US Patents and Regulatory Information for NEXAVAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes   Start Trial   Start Trial Y 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 NEXAVAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 PA 2006 008, C 1140840 Lithuania   Start Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 122006000059 Germany   Start Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 295 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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