You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 23, 2024

LURASIDONE HYDROCHLORIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, 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
⤷  Sign Up⤷  Sign Up120MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up80MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up60MGTABLET;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
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amneal Pharms Co LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208002-005 Jan 3, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208037-003 Sep 9, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 ⤷  Sign Up ⤷  Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 ⤷  Sign Up ⤷  Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 ⤷  Sign Up ⤷  Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 ⤷  Sign Up ⤷  Sign Up
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up
Canada 2606510 COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) ⤷  Sign Up
Japan WO2005009999 イミド化合物の製造方法 ⤷  Sign Up
China 1832946 Process for producing imide compound ⤷  Sign Up
Germany 60327634 ⤷  Sign Up
Spain 2535478 ⤷  Sign Up
>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 ⤷  Sign Up 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 2014/051 Ireland ⤷  Sign Up PRODUCT NAME: LURASIDONE, PARTICULARLY A PHARMACEUTICALLY ACCEPTABLE SALT FORM AND ESPECIALLY THE HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321
1884242 SPC/GB14/063 United Kingdom ⤷  Sign Up PRODUCT NAME: LURASIDONE HYDROCHLORIDE; REGISTERED: UK EU/1/14/913/001 20140327; UK EU/1/14/913/002 20140327; UK EU/1/14/913/003 20140327; UK EU/1/14/913/004 20140327; UK EU/1/14/913/005 20140327; UK EU/1/14/913/006 20140327; UK EU/1/14/913/007 20140327; UK EU/1/14/913/008 20140327; UK EU/1/14/913/009 20140327; UK EU/1/14/913/010 20140327; UK EU/1/14/913/011 20140327; UK EU/1/14/913/012 20140327; UK EU/1/14/913/013 20140327; UK EU/1/14/913/014 20140327; UK EU/1/14/913/015 20140327; UK EU/1/14/913/016 20140327; UK EU/1/14/913/017 20140327; UK EU/1/14/913/018 20140327; UK EU/1/14/913/019 20140327; UK EU/1/14/913/020 20140327; UK EU/1/14/913/021 20140327
1884242 551 Finland ⤷  Sign Up
1884242 122014000092 Germany ⤷  Sign Up 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 CR 2014 00049 Denmark ⤷  Sign Up PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.