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Last Updated: July 2, 2022

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 Pharms Ltd, Amneal Pharms Co, Dr Reddys, Emcure Pharms Ltd, Invagen Pharms, Lupin Ltd, Piramal Hlthcare Uk, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in fourteen 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. Four suppliers are listed for this compound. There are five tentative approvals for this compound.

Recent Clinical Trials for lurasidone hydrochloride

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

SponsorPhase
Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoPhase 4
Statistics Collaborative, Inc.Phase 2/Phase 3
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
See Plans and PricingSee Plans and Pricing120MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing80MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing60MGTABLET;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
Watson Labs Teva LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208016-004 Feb 2, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Lupin Ltd LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208031-001 Jan 3, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for lurasidone hydrochloride

Country Patent Number Title Estimated Expiration
Denmark 2422783 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005009999 See Plans and Pricing
Japan 6470164 See Plans and Pricing
Taiwan 200800197 Pharmaceutical composition See Plans and Pricing
South Korea 20080012306 PHARMACEUTICAL COMPOSITION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lurasidone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1884242 CR 2014 00049 Denmark See Plans and Pricing PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327
1884242 122014000092 Germany See Plans and Pricing 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 CA 2014 00049 Denmark See Plans and Pricing 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 SPC/GB14/063 United Kingdom See Plans and Pricing 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 C300690 Netherlands See Plans and Pricing PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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