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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Express Scripts
UBS
Moodys
QuintilesIMS
McKesson
Queensland Health
Baxter
Julphar

Generated: July 20, 2018

DrugPatentWatch Database Preview

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 twelve patent family members in fifty-six countries.

The generic ingredient in NEXAVAR is sorafenib tosylate. There are twelve 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
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.

Pharmacology for NEXAVAR
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for NEXAVAR
1-(4-(2-(METHYLCARBAMOYL)PYRIDIN-4-YLOXY)PHENYL)-3-(4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL)UREA
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-
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-((((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)-PYRIDINE-2-CARBOXYLIC ACID METHYLAMIDE
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-METHYL-2-PYRIDINECARBOXAMIDE
4-[4-([[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]CARBAMOYL]AMINO)PHENOXY]-N-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
AK163019
AKOS005560229
AM20090614
AN-613
AOB87782
BAY 43-9006
BAY 439006
BAY 545-9085
BAY-43-0006
BAY-43-9006
BAY-54-9085
BAY-545-9085
BAY43-9006
BAY439006
BC679588
BCPP000064
BDBM16673
Bio-0100
BRD-K23984367-001-01-8
CHEBI:50924
CHEMBL1336
cid_216239
CS-1590
CS0056
D08524
D0W5HK
DB00398
DTXSID7041128
EN002709
FT-0650736
GTPL5711
HE069468
HE200290
Hit compound, 8
HMS2043A18
HMS3244A15
HMS3244A16
HMS3244B15
HMS3656N20
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)-((4-(2-(N-METHYL-CARBAMOYL)(4-PYRIDYLOXY))PHENYL)AMINO)CARBOXAMIDE
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
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
Nexavar (TN)
Nexavar (TN) (Bayer)
Nexavar|||BAY 43-9006
NSC-724772
NSC-747971
NSC747971
OR252811
PB14443
Q-201728
QCR-65
RAF1 KINASE INHIBITOR II
RS0103
s7397
SC-19355
SCHEMBL8218
SF-0529
Sorafenib
Sorafenib (INN)
Sorafenib (Nexavar)
Sorafenib (Pan-TK inhibitor)
Sorafenib (USAN/INN)
Sorafenib [INN]
Sorafenib [USAN:INN:BAN]
SORAFENIB BASE
Sorafenib free base (BAY-43-9006)
Sorafenib tosilate
Sorafenib-d3
Sorafenib, 4
Sorafenibtosylate
sorafenibum
Sorafinib
SR-00000000529
SR-00000000529-1
STK627350
SYN1082
UNII-9ZOQ3TZI87
Z89277543
ZINC1493878

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y 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 NEXAVAR
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 200 mg ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for NEXAVAR

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
7,528,255 Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors ➤ Try a Free Trial
7,838,541 Aryl ureas with angiogenesis inhibiting activity ➤ Try a Free Trial
7,928,239 Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas ➤ Try a Free Trial
8,242,147 Aryl ureas with angiogenisis inhibiting activity ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NEXAVAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0034 France ➤ Try a Free Trial PRODUCT NAME: SORAFENIB TOSYLATE, ET AUTRES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE SORAFENIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/342/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/342/001 DU 20060719
C 031/2006 Ireland ➤ Try a Free Trial SPC 031/2006: 20070528, EXPIRES: 20210718
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
280 Luxembourg ➤ Try a Free Trial 91280, EXPIRES: 20210720
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Boehringer Ingelheim
UBS
AstraZeneca
Argus Health
Teva
Cantor Fitzgerald
Citi

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.