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Last Updated: May 19, 2024

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, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Avet Lifesciences, Dr Reddys, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, MSN, Slate Run Pharma, 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-nine patent family members in twenty-four countries.

There are twenty-six drug master file entries for lurasidone hydrochloride. Twenty-five 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
Statistics Collaborative, 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
Anatomical Therapeutic Chemical (ATC) Classes 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
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
Msn LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208037-002 Sep 9, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 200603-003 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 200603-002 Oct 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lurasidone hydrochloride

Country Patent Number Title Estimated Expiration
Brazil PI0611409 preparação oral e método de granulação de uma mistura em pó ⤷  Try a Trial
Japan 2011126915 PHARMACEUTICAL COMPOSITION ⤷  Try a Trial
European Patent Office 1535616 MEDICAMENT DESTINE AU SYNDROME DE LA DYSFONCTION D'INTEGRATION (REMEDY FOR INTEGRATION DYSFUNCTION SYNDROME) ⤷  Try a Trial
Poland 1884242 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lurasidone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1884242 14C0069 France ⤷  Try a 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 ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
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 C01884242/01 Switzerland ⤷  Try a Trial FORMER OWNER: SUMITOMO DAINIPPON PHARMA CO., LTD., JP
>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.