DrugPatentWatch Database Preview
SAVAYSA Drug Profile
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
When do Savaysa patents expire, and what generic alternatives are available?
Savaysa is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred patent family members in thirty-three countries.
The generic ingredient in SAVAYSA is edoxaban tosylate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the edoxaban tosylate profile page.
US ANDA Litigation and Generic Entry Outlook for Savaysa
Savaysa was eligible for patent challenges on January 8th, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 28th, 2028. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Summary for SAVAYSA
| International Patents: | 100 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 108 |
| Clinical Trials: | 9 |
| Patent Applications: | 71 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SAVAYSA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SAVAYSA |
| DailyMed Link: | SAVAYSA at DailyMed |
Generic Entry Opportunity Date for SAVAYSA
Generic Entry Date for SAVAYSA*:
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 SAVAYSA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Basildon and Thurrock University Hospitals NHS Foundation Trust | Phase 3 |
| King's College London | Phase 3 |
| University Hospital Plymouth NHS Trust | Phase 3 |
Recent Litigation for SAVAYSA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| DAIICHI SANKYO COMPANY, LIMITED v. KAPPOS |
Pharmacology for SAVAYSA
| Drug Class | Factor Xa Inhibitor |
| Mechanism of Action | Factor Xa Inhibitors |
Synonyms for SAVAYSA
| 1229194-11-9 |
| 32W99UE810 |
| 3601AH |
| 3602AH |
| 4-methylbenzene-1-sulfonic acid--N(1)-(5-chloropyridin-2-yl)-N(2)-{(1S,2R,4S)-4-(dimethylcarbamoyl)-2-[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl}ethanediamide (1/1) |
| 4-methylbenzene-1-sulfonic acid--N(1)-(5-chloropyridin-2-yl)-N(2)-{(1S,2R,4S)-4-(dimethylcarbamoyl)-2-[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl}ethanediamide--water (1/1/1) |
| 449E705 |
| 480449-70-5 |
| 480449-71-6 |
| 876652-15-2 |
| 912273-65-5 |
| 972203R4EW |
| A3383 |
| AB0028905 |
| AC-29306 |
| ACN-039922 |
| AK171134 |
| AKOS005146069 |
| AKOS022186217 |
| AKOS025289705 |
| AOB6678 |
| AOB87348 |
| API0007104 |
| AS-35107 |
| AS-35186 |
| AX8223833 |
| BCP14472 |
| BCP15112 |
| BDBM50328731 |
| C24H30ClN7O4S |
| C24H30ClN7O4S.C7H8O3S |
| C24H30ClN7O4S.C7H8O3S.H2O |
| CHEBI:85973 |
| CHEBI:85974 |
| CHEBI:85975 |
| CHEMBL1269025 |
| CHEMBL2105682 |
| CS-1331 |
| CS-1332 |
| CS-1333 |
| D09546 |
| D09710 |
| DB09075 |
| DTXSID10197399 |
| DTXSID50197398 |
| DTXSID60153788 |
| DU 176b |
| DU-176 |
| DU-176b |
| EDOXABAN |
| Edoxaban (tosylate monohydrate) |
| Edoxaban (tosylate) |
| Edoxaban (USAN/INN) |
| Edoxaban [USAN:INN] |
| edoxaban 4-toluenesulfonate |
| edoxaban monotosylate |
| edoxaban p-toluenesulfonate |
| Edoxaban p-toluenesulfonate monohydrate |
| Edoxaban tosilate |
| Edoxaban tosilate hydrate |
| Edoxaban tosilate hydrate (JAN) |
| Edoxaban tosilate monohydrate |
| Edoxaban tosylate |
| Edoxaban tosylate [USAN] |
| edoxaban tosylate hydrate |
| Edoxaban tosylate monohydrate |
| Edoxaban TsOH |
| Edoxaban TsOH salt |
| Ethanediamide, N-(5-chloro-2-pyridinyl)-N'-((1S,2R,4S)-4-((dimethylamino)carbonyl)-2-(((4,5,6,7-tetrahydro-5-methylthiazolo(5,4-c)pyridin-2-yl)carbonyl)amino)cyclohexyl)-, mono(4-methylbenzenesulfonate) |
| Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-((1S,2R,4S)-4- ((dimethylamino)carbonyl)- 2-(((4,5,6,7-tetrahydro-5-methylthiazolo(5,4-c)pyridin-2-yl)carbonyl)amino)cyclohexyl)- |
| Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-((1S,2R,4S)-4-((dimethylamino)carbonyl)- 2-(((4,5,6,7-tetrahydro-5-methylthiazolo(5,4-c)pyridin-2-yl)carbonyl)amino)cyclohexyl)-, 4-methylbenzenesulfonate (1:1) |
| GTPL7575 |
| HGVDHZBSSITLCT-JLJPHGGASA-N |
| HY-10264 |
| HY-10264A |
| HY-10264B |
| KS-000004VY |
| KS-000004VZ |
| Lixiana |
| LIXIANA (TN) |
| MolPort-018-493-670 |
| MolPort-035-944-324 |
| N-(5-Chloro-2-pyridinyl)-N'-[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]ethanediamide |
| N-(5-Chloropyridin-2-yl)-N'-((1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7- tetrahydro(1,3)thiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)oxamide |
| N-(5-Chloropyridin-2-yl)-N'-((1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7- tetrahydro(1,3)thiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)oxamide, 4- methylbenzenesulfonate |
| N-(5-chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-[(5-methyl-6,7-dihydro-4H-[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl]oxamide |
| N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide |
| N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide p-toluenesulfonate monohydrate |
| N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide p-toluenesulfonic acid |
| N'-(5-chloropyridin-2-yl)-N-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-[(5-methyl6,7-dihydro-4H-[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl]oxamide |
| N(1)-(5-chloropyridin-2-yl)-N(2)-{(1S,2R,4S)-4-(dimethylcarbamoyl)-2-[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl}ethanediamide |
| N1-(5-Chloropyridin-2-yl)-N 2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide p-toluenesulfonate monohydrate |
| N1-(5-chloropyridin-2-yl)-N2-((1S,2R,4S)-4-(dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl)oxalamide |
| N1-(5-Chloropyridin-2-yl)-N2-((1S,2R,4S)-4-(dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl)oxalamide 4-methylbenzenesulfonate hydrate |
| N1-(5-chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5, 6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl) ethanediamide |
| N1-(5-chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5, 6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl) ethanediamide p-toluenesulfonate monohydrate |
| N1-(5-Chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo [5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide p-toluenesulfonate Monohydrate |
| N1-(5-Chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide |
| N1-(5-Chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide mono-p-toluenesulfonate monohydrate |
| N1-(5-Chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide p-toluenesulfonate monohydrate |
| N1-(5-chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide p-toluenesulfonic acid monohydrate |
| N1-(5-Chloropyridin-2-yl)-N2-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide |
| N1-(5-chloropyridin-2-yl)-N2-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide p-toluenesulfonate monohydrate |
| NCGC00378907-03 |
| NDU3J18APO |
| PB31142 |
| PSMMNJNZVZZNOI-SJILXJHISA-N |
| Q-4449 |
| QC-10007 |
| s7280 |
| SCHEMBL330039 |
| SCHEMBL330046 |
| SCHEMBL330918 |
| ST24046675 |
| UNII-32W99UE810 |
| UNII-972203R4EW |
| UNII-NDU3J18APO |
| W-5624 |
| X1006 |
| X3723 |
| ZINC43200832 |
| ZLFZITWZOYXXAW-QXXZOGQOSA-N |
Paragraph IV (Patent) Challenges for SAVAYSA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SAVAYSA | TABLET;ORAL | edoxaban tosylate | 206316 | 2019-01-28 |
US Patents and Regulatory Information for SAVAYSA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-001 | Jan 8, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-002 | Jan 8, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-001 | Jan 8, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Daiichi Sankyo Inc | SAVAYSA | edoxaban tosylate | TABLET;ORAL | 206316-003 | Jan 8, 2015 | RX | Yes | Yes | Start Trial | Start Trial | 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 SAVAYSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2008241982 | Start Trial |
| Lithuania | PA2018005 | Start Trial |
| Mexico | 351987 | Start Trial |
| Taiwan | 200845972 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SAVAYSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2140867 | 292 50001-2018 | Slovakia | Start Trial | PRODUCT NAME: EDOXABAN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/993 20150623 |
| 1405852 | 51/2015 | Austria | Start Trial | PRODUCT NAME: EDOXABAN, EIN SALZ DAVON ODER EIN SOLVAT DAVON, INSBESONDERE EDOXABANTOSYLAT; REGISTRATION NO/DATE: EU/1/15/993/001-28 20150619 |
| 1405852 | 15C0068 | France | Start Trial | PRODUCT NAME: EDOXABAN,UN SEL,SOLVATE OU N-OXYDE DE CELUI-CI,EN PARTICULIER L'EDOXABAN TOSYLATE; REGISTRATION NO/DATE: EU/1/15/993 20150619 |
| 1405852 | 300760 | Netherlands | Start Trial | PRODUCT NAME: EDOXABAN, EEN ZOUT DAARVAN, EEN SOLVAAT DAARVAAN OF EEN N-OXIDE DAARVAN, IN HET BIJZONDER EDOXABAN TOSYLAAT; REGISTRATION NO/DATE: EU/1/15/993 20150619 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
