DrugPatentWatch Database Preview
NEXAVAR Drug Profile
Which patents cover Nexavar, and when can generic versions of Nexavar launch?
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.
The generic ingredient in NEXAVAR is sorafenib tosylate. There are twelve 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
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 97 |
| Clinical Trials: | 276 |
| Patent Applications: | 6 |
| 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.
Pharmacology for NEXAVAR
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Synonyms for NEXAVAR
| 1-(4-(2-(METHYLCARBAMOYL)PYRIDIN-4-YLOXY)PHENYL)-3-(4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL)UREA |
| 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- |
| 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-((((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)-PYRIDINE-2-CARBOXYLIC ACID METHYLAMIDE |
| 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-METHYL-2-PYRIDINECARBOXAMIDE |
| 4-[4-([[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]CARBAMOYL]AMINO)PHENOXY]-N-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 |
| AK163019 |
| AKOS005560229 |
| AM20090614 |
| AN-613 |
| AOB87782 |
| BAY 43-9006 |
| BAY 439006 |
| BAY 545-9085 |
| BAY-43-0006 |
| BAY-43-9006 |
| BAY-54-9085 |
| BAY-545-9085 |
| BAY43-9006 |
| BAY439006 |
| BC679588 |
| BCPP000064 |
| BDBM16673 |
| Bio-0100 |
| BRD-K23984367-001-01-8 |
| CHEBI:50924 |
| CHEMBL1336 |
| cid_216239 |
| CS-1590 |
| CS0056 |
| D08524 |
| D0W5HK |
| DB00398 |
| DTXSID7041128 |
| EN002709 |
| FT-0650736 |
| GTPL5711 |
| HE069468 |
| HE200290 |
| Hit compound, 8 |
| HMS2043A18 |
| HMS3244A15 |
| HMS3244A16 |
| HMS3244B15 |
| HMS3656N20 |
| 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)-((4-(2-(N-METHYL-CARBAMOYL)(4-PYRIDYLOXY))PHENYL)AMINO)CARBOXAMIDE |
| 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 |
| 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 |
| Nexavar (TN) |
| Nexavar (TN) (Bayer) |
| Nexavar|||BAY 43-9006 |
| NSC-724772 |
| NSC-747971 |
| NSC747971 |
| OR252811 |
| PB14443 |
| Q-201728 |
| QCR-65 |
| RAF1 KINASE INHIBITOR II |
| RS0103 |
| s7397 |
| SC-19355 |
| SCHEMBL8218 |
| SF-0529 |
| Sorafenib |
| Sorafenib (INN) |
| Sorafenib (Nexavar) |
| Sorafenib (Pan-TK inhibitor) |
| Sorafenib (USAN/INN) |
| Sorafenib [INN] |
| Sorafenib [USAN:INN:BAN] |
| SORAFENIB BASE |
| Sorafenib free base (BAY-43-9006) |
| Sorafenib tosilate |
| Sorafenib-d3 |
| Sorafenib, 4 |
| Sorafenibtosylate |
| sorafenibum |
| Sorafinib |
| SR-00000000529 |
| SR-00000000529-1 |
| STK627350 |
| SYN1082 |
| UNII-9ZOQ3TZI87 |
| Z89277543 |
| ZINC1493878 |
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 | ➤ 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 | ||
| 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 | ||
| 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 | ➤ 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 |
Paragraph IV (Patent) Challenges for NEXAVAR
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 200 mg | ➤ Subscribe | ➤ Try a Free Trial |
International Patents for NEXAVAR
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Malaysia | 162319 | ➤ Try a Free Trial |
| Honduras | 2000000007 | ➤ Try a Free Trial |
| Germany | 122006000059 | ➤ Try a Free Trial |
| Morocco | 26038 | ➤ Try a Free Trial |
| Australia | 2725000 | ➤ Try a Free Trial |
| Brazil | PI0608840 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for NEXAVAR
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 5 | Finland | ➤ Try a Free Trial | |
| 1140840/01 | Switzerland | ➤ Try a Free Trial | FORMER OWNER: BAYER HEALTHCARE LLC, US |
| /2006 | Austria | ➤ Try a Free Trial | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| 2006008 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| C0034 | France | ➤ Try a Free Trial | PRODUCT NAME: SORAFENIB TOSYLATE, ET AUTRES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE SORAFENIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/342/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/342/001 DU 20060719 |
| 2006000059 | Germany | ➤ Try a Free Trial | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
