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Generated: November 14, 2018

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Lurasidone hydrochloride - Generic Drug Details

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What are the generic drug sources for lurasidone hydrochloride and what is the scope of lurasidone hydrochloride patent protection?

Lurasidone hydrochloride is the generic ingredient in one branded drug marketed by Sunovion Pharms Inc and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for lurasidone hydrochloride. One supplier is listed for this compound. There are six tentative approvals for this compound.

Pharmacology for lurasidone hydrochloride
Synonyms for lurasidone hydrochloride
(1R,2S,6R,7S)-4-{[(1R,2R)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}-4-azatricyclo[5.2.1.0?,?]decane-3,5-dione
(3aR,4S,7R,7aS)-2-(((1R,2R)-2-((4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)methyl)cyclohexyl)methyl)hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione
(3aR,4S,7R,7aS)-2-(((1R,2R)-2-((4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)methyl)cyclohexyl)methyl)hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione hydrochloride
(3aR,4S,7R,7aS)-2-((1R,2R)-2-(4-(1,2-Benzothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl)hexahydro-4,7-methano-2H-isoindole-1,3-dione
(3aR,4S,7R,7aS)-2-[(1R,2R)-2-[4-(1,2-Benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl]hexahydro-1H-4,7-methanoisoindole-1,3-dione hydrochloride
(3aR,4S,7R,7aS)-2-[[(1R,2R)-2-[[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl]hexahydro-4,7-methano-1H-isoindole-1,3(2H)-dione
(3aR,4S,7R,7aS)-2-[[(1R,2R)-2-[4-(1,2-Benzoisothiazole-3-yl)piperazine-1-ylmethyl]cyclohexyl]methyl]-3a,4,5,6,7,7a-hexahydro-4,7-methano-2H-isoindole-1,3-dione
(3aR,4S,7R,7aS)-2-{(1R,2R)-2-(4-(1,2-Benzisothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione
(3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione
(3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride
(3aR,4S,7R,7aS)-2-{[(1R,2R)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione
(3aR,4S,7R,7aS)-2-{[(1R,2R)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione hydrochloride
1132654-54-6
22IC88528T
2525AH
367514-87-2
367514-88-3
4-(1,2-benzothiazol-3-yl)-1-{[(1R,2R)-2-{[(3aR,4S,7R,7aS)-1,3-dioxooctahydro-2H-4,7-methanoisoindol-2-yl]methyl}cyclohexyl]methyl}piperazin-1-ium chloride
4,7-Methano-1H-isoindole-1,3(2H)-dione, 2-(((1R,2R)-2-((4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)methyl)cyclohexyl)methyl)hexahydro-, monohydrochloride, (3aR,4S,7R,7aS)-
441351-20-8
AB01566875_01
ABP001018
AC1Q6F28
AK142737
AKOS022185856
AN-4137
API0013701
BDBM85222
C28H36N4O2S.ClH
CAS_441351-20-8
CHEBI:70732
CHEBI:70735
CHEMBL1237021
CHEMBL1615372
CTK1C3808
D01QGX
D04820
DB08815
EX-3124
EX-3125
EX-A504
GTPL7461
HE070280
HE338779
HSDB 8228
J-521660
Latuda
Latuda (TN)
lurasidona
Lurasidone
Lurasidone [INN]
Lurasidone HCl
Lurasidone hydrochloride (JAN/USAN)
Lurasidone hydrochloride (USAN)
Lurasidone hydrochloride [USAN]
Lurasidone hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
lurasidone monohydrochloride
Lurasidone-d8 Hydrochloride
Lurasidonhydrochloride
lurasidonum
MFCD00908886
MFCD14635357
MK-3756
MolPort-028-720-348
MolPort-035-395-724
N-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinylmethyl)-1-cyclohexylmethyl)-2,3-bicyclo(2.2.1)heptanedicarboximide
NEKCRUIRPWNMLK-SCIYSFAVSA-N
O0P4I5851I
PDSP2_001043
PQXKDMSYBGKCJA-CVTJIBDQSA-N
s3044
SC-93819
SCHEMBL1534132
SCHEMBL677525
SM 13496
SM-13496
SM13496
SMP-13496
ST1151106
ST24047511
UNII-22IC88528T
UNII-O0P4I5851I
W-5801
ZINC3927822
Tentative approvals for LURASIDONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up120MGTABLET;ORAL
➤ Sign Up➤ Sign Up80MGTABLET;ORAL
➤ Sign Up➤ Sign Up60MGTABLET;ORAL

US Patents and Regulatory Information for lurasidone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for lurasidone hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00690 Netherlands ➤ Sign Up PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321
90057-5 Sweden ➤ Sign Up PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
2014 00049 Denmark ➤ Sign Up PRODUCT NAME: LURASIDON, EVENTUELT I FORM AF DEN FRIE BASE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER LURASIDONHYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140321
14/051 Ireland ➤ Sign Up PRODUCT NAME: LURASIDONE, PARTICULARLY A PHARMACEUTICALLY ACCEPTABLE SALT FORM AND ESPECIALLY THE HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321
0140030 00118 Estonia ➤ Sign Up PRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014
2014000092 Germany ➤ Sign Up PRODUCT NAME: LURASIDON, INSBESONDERE EINE PHARMAZEUTISCH VERTRAEGLICHE SALZFORM UND IM SPEZIELLEN DAS HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Citi
AstraZeneca
UBS
Boehringer Ingelheim
McKinsey
Deloitte
Colorcon
Johnson and Johnson

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