LURASIDONE HYDROCHLORIDE - Generic Drug Details

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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-seven 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:	27
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208066-004	Jan 4, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Annora Pharma	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	218174-003	Aug 21, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208052-005	Mar 19, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208060-004	May 17, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Watson Labs Teva	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208016-003	Feb 2, 2021		DISCN	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

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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	200603-002	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	200603-001	Oct 28, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LURASIDONE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Australia	2004259305	Process for producing imide compound	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012063513		⤷ Sign Up
Japan	2011126915	PHARMACEUTICAL COMPOSITION	⤷ Sign Up
South Korea	101380088		⤷ Sign Up
South Korea	20130122019	PHARMACEUTICAL COMPOSITION	⤷ Sign Up
Slovenia	1884242		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004017973		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LURASIDONE HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1884242	300690	Netherlands	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1884242	551	Finland	⤷ Sign Up
1884242	PA2014034,C1884242	Lithuania	⤷ Sign Up	PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
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	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	56/2014	Austria	⤷ Sign Up	PRODUCT NAME: LURASIDON, GEGEBENENFALLS IN FORM SEINER FREIEN BASE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON.; REGISTRATION NO/DATE: EU/1/14/913 20140327
1884242	C300690	Netherlands	⤷ Sign Up	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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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.