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SAVAYSA Drug Profile

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.

Summary for SAVAYSA

International Patents:	100
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	107
Clinical Trials:	8
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

Drug patent expirations by year for SAVAYSA

Generic Entry Opportunity Date for SAVAYSA

Generic Entry Date for SAVAYSA^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial NDA: 206316 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
University Hospital Heidelberg	Phase 3
Azienda Ospedaliera di Perugia	Phase 3
King's College Hospital NHS Trust	Phase 3

See all SAVAYSA clinical trials

Recent Litigation for SAVAYSA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
DAIICHI SANKYO COMPANY, LIMITED v. KAPPOS

See all SAVAYSA litigation

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

US Patents and Regulatory Information for SAVAYSA

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Glossary

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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
>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 SAVAYSA

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Tablets	15 mg, 30 mg and 60 mg	➤ Subscribe	Start Trial

International Patents for SAVAYSA

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Country	Patent Number	Estimated Expiration
Israel	159438	Start Trial
Denmark	1405852	Start Trial
European Patent Office	2343290	Start Trial
Austria	556066	Start Trial
Malaysia	153231	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for SAVAYSA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C01405852/01	Switzerland	Start Trial	PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015
1405852	CR 2015 00052	Denmark	Start Trial	PRODUCT NAME: EDOXABAN, OR A SALT THEREOF, A SOLVATE THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REG. NO/DATE: EU/1/15/993/001-028 20150623
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	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description