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Generated: July 18, 2018

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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 twelve 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)
1-(4-chloro-3-(Trifluoromethyl)phenyl)-3-(4-((2-(methylcarbamoyl)pyridin-4-yl)oxy)phenyl)urea mono(4-methylbenzenesulfonic acid)
1-(4-chloro-3-(Trifluoromethyl)phenyl)-3-(4-((2-(methylcarbamoyl)pyridin-4-yl)oxy)phenyl)urea mono(4-methylbenzenesulphonate)
1-(4-chloro-3-(Trifluoromethyl)phenyl)-3-(4-((2-(methylcarbamoyl)pyridin-4-yl)oxy)phenyl)urea mono(4-methylbenzenesulphonic acid)
2-Pyridinecarboxamide, 4-(4-((((4-chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-, mono(4-methylbenzenesulfonate)
207S591
3(S),10(R)-OH-octadeca-6-trans-4,12-cis-trienoate
3(S),10(R)-OH-Octadeca-6-trans-4,12-cis-trienoic acid
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-{4-[3-(4-Cl-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 54-9085
BAY 54-9085Sorafenib tosylATE
BAY 54-9085Sorafenib tosylic acid
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
HE072572
HE344612
HMS2219E08
HMS3654I09
HY-10201A
IVDHYUQIDRJSTI-UHFFFAOYSA-N
KS-000006NB
LS-186598
MFCD08235032
MLS002415564
MolPort-006-705-989
NCGC00167488-01
NCGC00167488-08
ND-0228
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 (Tosylate)
Sorafenib tosilate
Sorafenib tosilate (JAN)
Sorafenib tosilic acid
Sorafenib tosylate (USAN)
Sorafenib tosylate [USAN]
Sorafenib Tosylate(Bay 43-9006)/
Sorafenib TsOH salt
Sorafenib, p-Toluenesulfonate salt
SORAFENIB; TOLUENESULFONIC ACID
SR-00000000529
SR-00000000529-5
ST24049296
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 ➤ Try a Free Trial ➤ Try a Free Trial 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 ➤ 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
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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Non-Orange Book US Patents for sorafenib tosylate

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

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Supplementary Protection Certificates for sorafenib tosylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
5 Finland ➤ Try a Free Trial
2006 008, C 1140840 Lithuania ➤ Try a Free Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
0242 Netherlands ➤ Try a Free Trial
2006008 Lithuania ➤ Try a Free Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
UBS
Argus Health
Farmers Insurance
Moodys
Fuji
Cerilliant
Julphar
Teva

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