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Last Updated: August 8, 2020

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Lurasidone hydrochloride - Generic Drug Details

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

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 nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lurasidone hydrochloride has sixty-six 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.

Recent Clinical Trials for lurasidone hydrochloride

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

SponsorPhase
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.Phase 3
New York State Psychiatric InstitutePhase 4
Columbia UniversityPhase 4

See all lurasidone hydrochloride clinical trials

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

Pharmacology for lurasidone hydrochloride
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 200603-003 Dec 7, 2011 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208060-004 May 17, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208002-003 Jan 3, 2019 DISCN No No   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 lurasidone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010   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 200603-001 Oct 28, 2010   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 200603-005 Jul 12, 2013   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 251 5024-2014 Slovakia   Start Trial PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
1884242 CR 2014 00049 Denmark   Start Trial PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327
1884242 C01884242/01 Switzerland   Start Trial PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: SWISSMEDIC 62785 12.08.2013
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 92550 Luxembourg   Start Trial PRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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