Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: September 18, 2019

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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 freedom to operate?

Lurasidone hydrochloride is the generic ingredient in two branded drugs marketed by Sunovion Pharms Inc, Accord Hlthcare, Amneal Pharms Co, Invagen Pharms, Lupin Ltd, Sun Pharm, Teva Pharms Usa, Torrent, and Zydus Pharms, and is included in nine 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-five patent family members in twenty-three countries.

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

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
Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Try a Free Trial  Try a Free Trial80MGTABLET;ORAL
  Try a Free Trial  Try a Free Trial60MGTABLET;ORAL
  Try a Free Trial  Try a Free Trial40MGTABLET;ORAL

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

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   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
Amneal Pharms Co LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208002-005 Jan 3, 2019 DISCN No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
Lupin Ltd LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208031-004 Jan 3, 2019 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
>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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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 200603-001 Oct 28, 2010   Try a Free Trial   Try a Free Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011   Try a Free Trial   Try a Free Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010   Try a Free Trial   Try a Free Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012   Try a Free Trial   Try a Free Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Supplementary Protection Certificates for lurasidone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1884242 1490057-5 Sweden   Try a Free Trial PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
1884242 C 2014 038 Romania   Try a Free Trial PRODUCT NAME: LURASIDONA, OPTIONAL SUB FORMA BAZEI EI LIBERE SAU CA SARURIACCEPTABILE FARMACEUTIC ALE ACESTEIA, IN SPECIAL CLORHIDRAT DE LURASIDONA -C28H36N4O2S; NATIONAL AUTHORISATION NUMBER: EU/1/14/913; DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/913; DATE OF FIRST AUTHORISATION IN EEA: 20140321
1884242 14C0069 France   Try a Free 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 122014000092 Germany   Try a Free Trial PRODUCT NAME: LURASIDON, INSBESONDERE EINE PHARMAZEUTISCH VERTRAEGLICHE SALZFORM UND IM SPEZIELLEN DAS HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321
1884242 551 Finland   Try a Free Trial
1884242 300690 Netherlands   Try a Free 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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