LURASIDONE HYDROCHLORIDE - Generic Drug Details

✉ Email this page to a colleague

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, Annora Pharma, 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 nineteen 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-eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for LURASIDONE HYDROCHLORIDE

International Patents:	69
US Patents:	9
Tradenames:	2
Applicants:	19
NDAs:	19
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	79
Patent Applications:	121
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LURASIDONE HYDROCHLORIDE
What excipients (inactive ingredients) are in LURASIDONE HYDROCHLORIDE?	LURASIDONE HYDROCHLORIDE excipients list
DailyMed Link:	LURASIDONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for LURASIDONE HYDROCHLORIDE

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

Sponsor	Phase
First Affiliated Hospital of Zhejiang University	Phase 4
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Phase 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 Up	120MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	80MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	60MG	TABLET;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

Drug Class	Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for LURASIDONE HYDROCHLORIDE

Adrenergic alpha-2 Receptor Antagonists
Antipsychotic Agents
Dopamine D2 Receptor Antagonists
Serotonin 5-HT2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for LURASIDONE HYDROCHLORIDE

N05AE	Indole derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	208031-005	Jan 3, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208066-003	Jan 4, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Slate Run Pharma	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	212091-004	Dec 28, 2020	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
Zydus Pharms	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208052-002	Mar 19, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208066-004	Jan 4, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	212244-005	Dec 13, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	200603-001	Oct 28, 2010	⤷ 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	200603-002	Oct 28, 2010	⤷ Sign Up	⤷ Sign Up
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	⤷ Sign Up	⤷ Sign Up
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	⤷ Sign Up	⤷ Sign Up
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LURASIDONE HYDROCHLORIDE

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
European Patent Office	2638038	PROCÉDÉ DE TRAITEMENT DE TROUBLES MENTAUX (METHOD OF TREATMENT FOR MENTAL DISORDERS)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004017973		⤷ Sign Up
Japan	2011126915	PHARMACEUTICAL COMPOSITION	⤷ Sign Up
China	101184489	Pharmaceutical composition	⤷ Sign Up
European Patent Office	2295061	Agent pour le traitement de la schizophrénie (Agent for treatment of schizophrenia)	⤷ Sign Up
Spain	2685780		⤷ Sign Up
China	1832946	Process for producing imide compound	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LURASIDONE HYDROCHLORIDE

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	251 5024-2014	Slovakia	⤷ Sign Up	PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
1884242	CR 2014 00049	Denmark	⤷ Sign Up	PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327
1884242	551	Finland	⤷ Sign Up
1884242	92550	Luxembourg	⤷ Sign Up	PRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 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	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
>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.