Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Medtronic
Moodys
McKinsey
Mallinckrodt

Last Updated: November 12, 2019

DrugPatentWatch Database Preview

Sorafenib tosylate - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic sources for sorafenib tosylate and what is the scope of freedom to operate?

Sorafenib tosylate is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sorafenib tosylate has two hundred and thirteen patent family members in fifty-six countries.

There are thirteen drug master file entries for sorafenib tosylate. One supplier is listed for this compound.

Recent Clinical Trials for sorafenib tosylate

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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
University of WashingtonPhase 1/Phase 2
Dana-Farber Cancer InstitutePhase 1

See all sorafenib tosylate clinical trials

Recent Litigation for sorafenib tosylate

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 sorafenib tosylate litigation

Pharmacology for sorafenib tosylate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for sorafenib tosylate
1-(4-Chloro-3-(trifluoromethyl)phenyl)-3-(4-((2-(methylcarbamoyl)pyridin-4-yl)oxy)phenyl)urea mono(4-methylbenzenesulfonate)
2-Pyridinecarboxamide, 4-(4-((((4-chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-, mono(4-methylbenzenesulfonate)
207S591
4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl)ureido)phenoxy)-N-methylpicolinamide 4-methylbenzenesulfonate
4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl)ureido)phenoxy)-N-methylpicolinamide tosylate
4-(4-(3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido)phenoxy)-N2-methylpyridine-2-carboxamide mono (4-methylbenzenesulfonate)
4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide 4-methylbenzenesulfonate
4-[4-[[[4-chloro-3-(trifluoromethyl)anilino]-oxomethyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide; 4-methylbenzenesulfonic acid
4-[4-[[4-chloranyl-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methyl-pyridine-2-carboxamide; 4-methylbenzenesulfonic acid
4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide; 4-methylbenzenesulfonic acid
4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide;4-methylbenzenesulfonic acid
4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)-amino]phenoxy}-N-methylpyridine-2-carboxamide tosylate
4-{4-[({[4-Chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)amino]phenoxy}-N -methylpyridine-2-carboxamide tosylate
4-{4-[({[4-Chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)amino]phenoxy}-N-methylpyridine-2-carboxamide tosylate
4-{4-[3-(4-Chloro-3-trifluoromethyl-phenyl)-ureido]-phenoxy} -pyridine-2-carboxylic acid methylamide-4-methylbenzenesulfonate
4-methylbenzolsulfons
475207-59-1
5T62Q3B36J
A20368
A819449
AB0044027
ABP000935
AC-6799
AC1L8QVY
AC1Q5GRN
AK162385
AKOS015924650
AKOS027469919
AM20090612
AOB87366
AT-17079
BAY 43-9006 mono-p-tosylate
BAY 43-9006 tosylate
BAY 43-9006; Nexavar
BAY 54-9085
BAY-54-9085
BAY43-9006 mono-p-tosylate
BCP0726000112
C28H24ClF3N4O6S
CAS-475207-59-1
CCG-208000
CHEBI:50928
CHEMBL1200485
CS-0164
D06272
DSSTox_CID_27817
DSSTox_GSID_47839
DSSTox_RID_82581
DTXSID9047839
FT-0650737
FT-0698449
HMS2219E08
HMS3654I09
HY-10201A
IVDHYUQIDRJSTI-UHFFFAOYSA-N
KS-000006NB
LS-186598
MLS002415564
MolPort-006-705-989
NCGC00167488-01
NCGC00167488-08
ND-0228
Nexavar
Nexavar (TN)
Nexavar(R)
NSC-724772
NSC724772
para-toluene sulfonate sorafenib tosylate
PubChem22488
Q-1222
Q-201729
Q812
RL03773
S-8502
s1040
SMR001339079
Sorafenib - Nexavar
Sorafenib (BAY-43-9006)
Sorafenib (Nexavar)
Sorafenib (Tosylate)
Sorafenib tosilate (JAN)
Sorafenib tosylate (USAN)
Sorafenib tosylate [USAN]
Sorafenib Tosylate(Bay 43-9006)/
Sorafenib TsOH salt
Sorafenib, p-Toluenesulfonate salt
SR-00000000529
SR-00000000529-5
ST24049296
SW202562-3
Tox21_112489
Tox21_112489_1
UNII-5T62Q3B36J
Paragraph IV (Patent) Challenges for SORAFENIB TOSYLATE
Tradename Dosage Ingredient NDA Submissiondate
NEXAVAR TABLET;ORAL sorafenib tosylate 021923 2014-02-28

US Patents and Regulatory Information for sorafenib tosylate

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 Y   Start Trial
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   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
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   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 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 sorafenib tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 300242 Netherlands   Start Trial
1140840 35/2006 Austria   Start Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; 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 PA2006008,C1140840 Lithuania   Start Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 SZ 35/2006 Austria   Start Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
>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:

AstraZeneca
Colorcon
Mallinckrodt
Baxter
Moodys
McKinsey

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.