DrugPatentWatch Database Preview
Sorafenib tosylate - Generic Drug Details
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.
Summary for sorafenib tosylate
| International Patents: | 213 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 13 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 93 |
| 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 |
Recent Clinical Trials for sorafenib tosylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
| University of Washington | Phase 1/Phase 2 |
| Dana-Farber Cancer Institute | Phase 1 |
Recent Litigation for sorafenib tosylate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| 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 |
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) |
| 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 |
International Patents for sorafenib tosylate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1797038 | Start Trial |
| Australia | 2501600 | Start Trial |
| Estonia | 200100368 | Start Trial |
| Jordan | 2373 | Start Trial |
| Singapore | 160364 | Start Trial |
| Bulgaria | 105763 | Start Trial |
| Japan | 2003526613 | Start Trial |
| >Country | >Patent Number | >Estimated 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:
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.
Copyright 2002-2019 thinkBiotech LLC
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.