Sorafenib tosylate - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions

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

Sorafenib tosylate is the generic ingredient in two branded drugs marketed by Bayer Hlthcare, Dr Reddys, Mylan, and Teva Pharms Usa Inc, and is included in four NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sorafenib tosylate has one hundred and three patent family members in thirty-nine countries.

There are twelve drug master file entries for sorafenib tosylate. Three suppliers are listed for this compound.

Summary for sorafenib tosylate

International Patents:	103
US Patents:	3
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	164
Patent Applications:	8
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sorafenib tosylate
DailyMed Link:	sorafenib tosylate at DailyMed

Recent Clinical Trials for sorafenib tosylate

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

Sponsor	Phase
Southern Medical University, China	Phase 2/Phase 3
Jiangxi Province Children's Hospital	Phase 2/Phase 3
The First Affiliated Hospital of Nanchang University	Phase 2/Phase 3

See all sorafenib tosylate clinical trials

Pharmacology for sorafenib tosylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for SORAFENIB TOSYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXAVAR	Tablets	sorafenib tosylate	200 mg	021923	1	2014-02-28

US Patents and Regulatory Information for sorafenib tosylate

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try it Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	207012-001	Sep 10, 2020	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Teva Pharms Usa Inc	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	209567-001	Nov 12, 2020		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Dr Reddys	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	216073-001	Jun 7, 2022	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for sorafenib tosylate

Subscribe to access the full database, or Try it Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	See Plans and Pricing	See Plans and Pricing
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	See Plans and Pricing	See Plans and Pricing
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	See Plans and Pricing	See Plans and Pricing
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	See Plans and Pricing	See Plans and Pricing
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for sorafenib tosylate

Subscribe to access the full database, or Try it Free
Country	Patent Number	Title	Estimated Expiration
Ukraine	91520	ТЕРМОДИНАМІЧНО СТАБІЛЬНА ФОРМА ТОЗИЛАТУ[ТЕРМОДИНАМИЧЕСКИ СТАБИЛЬНАЯ ФОРМА ТОЗИЛАТА (THERMODYNAMICALLY STABLE FORM OF TOSYLATE)	See Plans and Pricing
Taiwan	200700093	Pharmaceutical composition for the treatment of cancer	See Plans and Pricing
New Zealand	561178	Pharmaceutical composition comprising an omega-carboxyaryl substituted diphenyl urea for the treatment of cancer	See Plans and Pricing
South Africa	200702510	Thermodynamically stable form of bay 43-9006 tosylate	See Plans and Pricing
Cyprus	1113598		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for sorafenib tosylate

Subscribe to access the full database, or Try it Free
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140840	122006000059	Germany	See Plans and Pricing	PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	35/2006	Austria	See Plans and Pricing	PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	SPC/GB07/004	United Kingdom	See Plans and Pricing	PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1140840	PA2006008,C1140840	Lithuania	See Plans and Pricing	PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	SZ 35/2006	Austria	See Plans and Pricing	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:

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 verification 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.