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Last Updated: March 28, 2024

Lurasidone hydrochloride - Generic Drug Details


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What are the generic drug 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, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Avet Lifesciences, Dr Reddys, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, MSN, Piramal Hlthcare Uk, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in eighteen 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-eight patent family members in twenty-four countries.

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

Recent Clinical Trials for lurasidone hydrochloride

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

SponsorPhase
First Affiliated Hospital of Zhejiang UniversityPhase 4
Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoPhase 4
NeuroRx, Inc.Phase 2/Phase 3

See all lurasidone hydrochloride clinical trials

Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial120MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial80MGTABLET;ORAL
⤷  Try a Trial⤷  Try a 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
Paragraph IV (Patent) Challenges for LURASIDONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LATUDA Tablets lurasidone hydrochloride 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg 200603 14 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
Lupin Ltd LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208031-001 Jan 3, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Avet Lifesciences LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208058-002 Sep 4, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Invagen Pharms LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208028-005 Jan 3, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 200603-001 Oct 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 ⤷  Try a Trial ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 ⤷  Try a Trial ⤷  Try a 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 1490057-5 Sweden ⤷  Try a Trial PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
1884242 CA 2014 00049 Denmark ⤷  Try a Trial 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
1884242 C300690 Netherlands ⤷  Try a 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 C20140030 00118 Estonia ⤷  Try a Trial PRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.