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SAVAYSA Drug Profile
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» See Plans and PricingWhen do Savaysa patents expire, and when can generic versions of Savaysa launch?
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 and one 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 8, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 28, 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.
Indicators of Generic Entry
Summary for SAVAYSA
| International Patents: | 101 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 110 |
| 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 |
|---|---|
| Hull and East Yorkshire Hospitals NHS Trust | Phase 3 |
| St Helens & Knowsley Teaching Hospitals NHS Trust | Phase 3 |
| Wuerzburg University Hospital | 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 |
| 912273-65-5 |
| 972203R4EW |
| A14317 |
| A3383 |
| AB0028905 |
| AC-29306 |
| ACN-039922 |
| AK171134 |
| AKOS005146069 |
| 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 |
| D11568 |
| DB09075 |
| DTXSID10197399 |
| DTXSID50197398 |
| DTXSID60153788 |
| DU 176b |
| DU-176 |
| DU-176b |
| DU-176b tosylate Monohydrate |
| 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 [USAN] |
| edoxaban tosylate hydrate |
| Edoxaban tosylate monohydrate |
| Edoxaban TsOH |
| Edoxaban TsOH salt |
| edoxaban-tosylate-monohydrate |
| 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) |
| 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, hydrate (1:1:1) |
| GTPL7575 |
| HGVDHZBSSITLCT-JLJPHGGASA-N |
| HY-10264 |
| HY-10264A |
| HY-10264B |
| KS-000004VY |
| KS-000004VZ |
| Lixiana |
| LIXIANA (TN) |
| 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 |
| Q21011234 |
| Q27158827 |
| QC-10007 |
| s7280 |
| Savaysa (TN) |
| 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 | ||||
| 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 | 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 SAVAYSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 101652139 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03000657 | Start Trial |
| South Africa | 200309866 | Start Trial |
| Israel | 200790 | Start Trial |
| Norway | 2015022 | Start Trial |
| Israel | 159438 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SAVAYSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1405852 | 2015/045 | Ireland | Start Trial | PRODUCT NAME: EDOXABAN, A SALT THEREOF, A SOLVATIC THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619 |
| 1405852 | 132016000024022 | Italy | Start Trial | PRODUCT NAME: EDOXABAN, UN SUO SALE, UN SUO SOLVATO O UN SUO N-OSSIDO, IN PARTICOLARE EDOXABAN TOSILATO(LIXIANA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/993/001-028, 20150623 |
| 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 |
| 2140867 | PA2018005,C2140867 | Lithuania | Start Trial | PRODUCT NAME: EDOKSABANAS, JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, ARBA BET KURIO IS JU HIDRATAS, YPAC EDOKSABANO P-TOLUENSULFONATO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619 |
| 1405852 | 92835 | Luxembourg | Start Trial | PRODUCT NAME: EDOXABAN, UN DE SES SELS, UN DE SES SOLVATES OU UN N-OXYDE DE CELUI-CI, EN PARTICULIER UN TOSYLATE D EDOXABAN. FIRST REGISTRATION: 20150619 |
| 1405852 | C01405852/01 | Switzerland | Start Trial | PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
