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Boehringer Ingelheim
Baxter
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Covington
US Army
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Generated: October 21, 2018

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LATUDA Drug Profile

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When do Latuda patents expire, and when can generic versions of Latuda launch?

Latuda is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.

Drug patent expirations by year for LATUDA
Generic Entry Opportunity Date for LATUDA
Generic Entry Date for LATUDA*:
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 LATUDA
Synonyms for LATUDA
(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 (TN)
lurasidona
Lurasidone
Lurasidone [INN]
Lurasidone HCl
Lurasidone hydrochloride
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

US Patents and Regulatory Information for LATUDA

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 Y ➤ Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 RX Yes Yes ➤ 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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Paragraph IV (Patent) Challenges for LATUDA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for LATUDA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Moodys
QuintilesIMS
Covington
US Army
Teva
Mallinckrodt
Harvard Business School

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