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Last Updated: January 23, 2020

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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 freedom to operate?

Lurasidone hydrochloride is the generic ingredient in two branded drugs marketed by Sunovion Pharms Inc, Accord Hlthcare, Amneal Pharms Co, Emcure Pharms Ltd, Invagen Pharms, Lupin Ltd, Sun Pharm, Teva Pharms Usa, Torrent, and Zydus Pharms, and is included in ten NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lurasidone hydrochloride has seventy-six patent family members in twenty-four countries.

There are twenty-six drug master file entries for lurasidone hydrochloride. Two suppliers are listed for this compound. There are five tentative approvals for this compound.

Recent Clinical Trials for lurasidone hydrochloride

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

SponsorPhase
New York State Psychiatric InstitutePhase 4
Columbia UniversityPhase 4
Massachusetts General HospitalEarly Phase 1

See all lurasidone hydrochloride clinical trials

Recent Litigation for lurasidone hydrochloride

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 lurasidone hydrochloride litigation

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

See all lurasidone hydrochloride litigation

Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial120MGTABLET;ORAL
  Start Trial  Start Trial80MGTABLET;ORAL
  Start Trial  Start Trial60MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for lurasidone hydrochloride
Synonyms for lurasidone hydrochloride
(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-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)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 hydrochloride
1132654-54-6
2525AH
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
AK142737
AKOS022185856
AS-35074
C28H36N4O2S.ClH
CHEBI:70732
CHEMBL1615372
D04820
EX-3125
Latuda
Latuda (TN)
Lurasidone HCl
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
MK-3756
MolPort-035-395-724
NEKCRUIRPWNMLK-SCIYSFAVSA-N
O0P4I5851I
s3044
SB16829
SCHEMBL1534132
SM 13496
SM-13496
SMP-13496
UNII-O0P4I5851I
W-5801
Paragraph IV (Patent) Challenges for LURASIDONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
LATUDA TABLET;ORAL lurasidone hydrochloride 200603 2014-10-28

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 200603-001 Oct 28, 2010 AB RX Yes Yes   Start Trial   Start Trial   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 200603-004 Apr 26, 2012 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
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 200603-004 Apr 26, 2012 AB 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

Expired US Patents for lurasidone hydrochloride

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
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for lurasidone hydrochloride

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
1884242 14C0069 France   Start Trial PRODUCT NAME: LURASIDONE, EN PARTICULIER SOUS LA FORME DE L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/14/913 20140327
1884242 300690 Netherlands   Start Trial PRODUCT NAME: LURASIDON HYDROCHLORIDE; REGISTRATION 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:

Johnson and Johnson
Express Scripts
Harvard Business School
Mallinckrodt
McKinsey
McKesson

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