DrugPatentWatch Database Preview
NEXAVAR Drug Profile
When do Nexavar patents expire, and what generic alternatives are available?
Nexavar is a drug marketed by Bayer Hlthcare and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and thirteen patent family members in fifty-six countries.
The generic ingredient in NEXAVAR is sorafenib tosylate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sorafenib tosylate profile page.
Summary for NEXAVAR
| International Patents: | 213 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 106 |
| Clinical Trials: | 286 |
| Patent Applications: | 5,661 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NEXAVAR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEXAVAR |
| DailyMed Link: | NEXAVAR at DailyMed |
Generic Entry Opportunity Date for NEXAVAR
Generic Entry Date for NEXAVAR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for NEXAVAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yiviva Inc. | Phase 2 |
| Institut du Cancer de Montpellier - Val d'Aurelle | Phase 3 |
| Samyang Biopharmaceuticals Corporation | Phase 1 |
Recent Litigation for NEXAVAR
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 NEXAVAR
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Synonyms for NEXAVAR
| 100012-18-8 |
| 15216-EP2272827A1 |
| 15216-EP2298778A1 |
| 15216-EP2311840A1 |
| 15216-EP2316832A1 |
| 15216-EP2316833A1 |
| 1uwh |
| 2-Pyridinecarboxamide, 4-(4-((((4-chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl- |
| 2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl- |
| 284461-73-0 |
| 3gcs |
| 3heg |
| 4-(4-((((4-Chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-2-pyridinecarboxamide |
| 4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl) ureido) phenoxy)-N-methylpicolinamide |
| 4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl) ureido)phenoxy)-N-methylpicolinamide |
| 4-(4-(3-(4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL)UREIDO)PHENOXY)-N-METHYLPICOLINAMIDE |
| 4-(4-(3-(4-chloro-3-trifluoromethylphenyl)ureido)phenoxy)pyridine-2-carboxyllic acid methyamide-4-methylbenzenesulfonate |
| 4-(4-{3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido}phenoxy)-N(sup 2)-methylpyridine-2-carboxamide |
| 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N2-methylpyridine-2-carboxamide |
| 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide |
| 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide |
| 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methyl-picolinamide;tosylic acid |
| 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methyl-pyridine-2-carboxamide |
| 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide |
| 4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)-amino]phenoxy}-N-methylpyridine-2-carboxamide |
| 4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)amino]phenoxy}-N-methyl-pyridine-2-carboxamide |
| 4-{4-[({[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]AMINO}CARBONYL)AMINO]PHENOXY}-N-METHYLPYRIDINE-2-CARBOXAMIDE |
| 4(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N(sup 2)-methylpyridine-2-carboxamide |
| 461S730 |
| 4asd |
| 9ZOQ3TZI87 |
| AB0019677 |
| AB00933189_08 |
| AB00933189-05 |
| AB00933189-06 |
| AB1004622 |
| AC-1674 |
| AC1L50CF |
| ACN-032355 |
| ACT06732 |
| AKOS005560229 |
| AM20090614 |
| AN-613 |
| AOB87782 |
| BAX |
| BAY 43-9006 |
| BAY 439006 |
| BAY-43-0006 |
| BAY-43-9006 |
| BAY-54-9085 |
| BAY43-9006 |
| BAY439006 |
| BC679588 |
| BCP01767 |
| BCPP000064 |
| BDBM16673 |
| BRD-K23984367-001-01-8 |
| CHEBI:50924 |
| CHEMBL1336 |
| cid_216239 |
| CS-1590 |
| CS0056 |
| D08524 |
| DB00398 |
| DTXSID7041128 |
| EC 608-209-4 |
| EN002709 |
| FT-0650736 |
| GTPL5711 |
| Hit compound, 8 |
| HMS2043A18 |
| HMS3244A15 |
| HMS3244A16 |
| HMS3244B15 |
| HMS3656N20 |
| HSDB 8173 |
| HY-10201 |
| I06-0856 |
| J10391 |
| K00597a |
| KB-60586 |
| KB-80670 |
| Kinome_766 |
| KS-0000009E |
| LS-186067 |
| LS-187021 |
| LS-187788 |
| MCULE-6112506696 |
| MFCD06411450 |
| MLDQJTXFUGDVEO-UHFFFAOYSA-N |
| MolPort-003-850-270 |
| N-(3-trifluoromethyl-4-chlorophenyl)-N'-(4-(2-methylcarbamoyl pyridin-4-yl)oxyphenyl)urea |
| N-(4-chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcar bamoyl)-4-pyridyloxy)phenyl)urea |
| N-(4-chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl) urea |
| N-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea |
| N-[4-Chloro-3-(trifluoromethyl)phenyl]-N'-[4-[2-(N-methylcarbamoyl)-4-pyridyloxy]phenyl]urea; 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide |
| NCGC00167488-01 |
| NCGC00167488-02 |
| NCGC00167488-03 |
| NCGC00167488-04 |
| NCGC00167488-05 |
| NCGC00167488-07 |
| NCGC00167488-14 |
| Nexavar (TN) (Bayer) |
| Nexavar|||BAY 43-9006 |
| NSC-724772 |
| NSC-747971 |
| NSC747971 |
| PB14443 |
| Q-201728 |
| QCR-65 |
| RS0103 |
| s7397 |
| SB19942 |
| SC-19355 |
| SCHEMBL8218 |
| SF-0529 |
| Sorafenib |
| Sorafenib (Nexavar) |
| Sorafenib (USAN/INN) |
| Sorafenib [INN] |
| Sorafenib [USAN:INN:BAN] |
| SORAFENIB BASE |
| Sorafenib free base (BAY-43-9006) |
| Sorafenib-d3 |
| Sorafenib, 4 |
| sorafenibum |
| Sorafinib |
| SR-00000000529 |
| SR-00000000529-1 |
| STK627350 |
| SW202562-4 |
| SYN1082 |
| UNII-9ZOQ3TZI87 |
| Z89277543 |
| ZINC1493878 |
Paragraph IV (Patent) Challenges for NEXAVAR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NEXAVAR | TABLET;ORAL | sorafenib tosylate | 021923 | 2014-02-28 |
US Patents and Regulatory Information for NEXAVAR
| 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 | 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 | Y | 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 NEXAVAR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 144144 | Start Trial |
| Czech Republic | 20012489 | Start Trial |
| Ukraine | 91520 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NEXAVAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 122006000059 | Germany | Start Trial | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| 1140840 | 295 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
