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Generated: April 18, 2019

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Sorafenib tosylate - Generic Drug Details

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What are the generic sources for sorafenib tosylate and what is the scope of sorafenib tosylate 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 twelve patent family members in fifty-six countries.

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

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

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Supplementary Protection Certificates for sorafenib tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 06C0034 France ➤ Sign Up 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
1140840 SPC/GB07/004 United Kingdom ➤ Sign Up PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1140840 SPC 031/2006 Ireland ➤ Sign Up SPC 031/2006: 20070528, EXPIRES: 20210718
1140840 C01140840/01 Switzerland ➤ Sign Up FORMER OWNER: BAYER HEALTHCARE LLC, US
1140840 PA2006008 Lithuania ➤ Sign Up PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Fuji
Chubb
Julphar
AstraZeneca

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