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Last Updated: January 23, 2020

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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.

This drug has seventy-six patent family members in twenty-four countries.

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

Drug patent expirations by year for LATUDA
Drug Prices for LATUDA

See drug prices for LATUDA

Drug Sales Revenue Trends for LATUDA

See drug sales revenues for LATUDA

Recent Clinical Trials for LATUDA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Columbia UniversityPhase 4
New York State Psychiatric InstitutePhase 4
Astellas Pharma Global Development, Inc.Phase 2

See all LATUDA clinical trials

Recent Litigation for LATUDA

Identify potential future generic entrants

District Court Litigation
Case NameDate
PIRAMAL HEALTHCARE UK LIMITED v. SUMITOMO DAINIPPON PHARMA CO., LTD.2019-06-26
SUMITOMO DAINIPPON PHARMA CO., LTD. v. ALKEM LABORATORIES LIMITED2018-10-09
SUMITOMO DAINIPPON PHARMA CO., LTD. v. MACLEODS PHARMACEUTICALS LTD.2018-09-12

See all LATUDA litigation

PTAB Litigation
PetitionerDate
Par Pharmaceutical, Inc.2017-04-18

See all LATUDA litigation

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
AS-35074
AS-35077
BDBM85222
C28H36N4O2S.ClH
CAS_441351-20-8
CHEBI:70732
CHEBI:70735
CHEMBL1237021
CHEMBL1615372
CTK1C3808
D04820
DB08815
EX-3124
EX-3125
EX-A504
GTPL7461
HSDB 8228
J-521660
Latuda (TN)
lurasidona
Lurasidone
Lurasidone [INN]
Lurasidone HCl
Lurasidone hydrochloride
Lurasidone hydrochloride (JAN/USAN)
Lurasidone hydrochloride [USAN]
Lurasidone hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Lurasidone hydrochloride, >=98% (HPLC)
lurasidone monohydrochloride
Lurasidone-d8 Hydrochloride
Lurasidonhydrochloride
lurasidonum
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
SB16828
SB16829
SC-93819
SCHEMBL1534132
SCHEMBL677525
SM 13496
SM-13496
SM13496
SMP-13496
ST1151106
ST24047511
UNII-22IC88528T
UNII-O0P4I5851I
W-5801
ZINC3927822
Paragraph IV (Patent) Challenges for LATUDA
Tradename Dosage Ingredient NDA Submissiondate
LATUDA TABLET;ORAL lurasidone hydrochloride 200603 2014-10-28

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 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 AB 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

Expired US Patents for LATUDA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LATUDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1884242 PA2014034 Lithuania   Start Trial PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242 C300690 Netherlands   Start Trial PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242 1490057-5 Sweden   Start Trial PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
Harvard Business School
Merck
Johnson and Johnson
Express Scripts

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