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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.

Summary for sorafenib tosylate

International Patents:	212
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	12
Suppliers / Packagers:	1
Bulk Api Vendors:	79
Clinical Trials:	158
Patent Applications:	6
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sorafenib tosylate
DailyMed Link:	sorafenib tosylate at DailyMed

Pharmacology for sorafenib tosylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein 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				Y
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005		RX	Yes	Yes
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005		RX	Yes	Yes
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005		RX	Yes	Yes			Y	Y

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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
8,242,147	Aryl ureas with angiogenisis inhibiting activity
7,528,255	Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors
7,928,239	Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas

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International Patents for sorafenib tosylate

Country	Document Number	Estimated Expiration
Slovakia	287419
World Intellectual Property Organization (WIPO)	0042012
Spain	2255971
Panama	8489701

Supplementary Protection Certificates for sorafenib tosylate

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