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

Summary for lurasidone hydrochloride

International Patents:	66
US Patents:	9
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	26
Suppliers / Packagers:	2
Bulk Api Vendors:	39
Clinical Trials:	70
Patent Applications:	14
Formulation / Manufacturing:	see details
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
Jayasree Basivireddy	Phase 3
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.	Phase 3
New York State Psychiatric Institute	Phase 4

See all lurasidone hydrochloride clinical trials

Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		20MG	TABLET;ORAL
		120MG	TABLET;ORAL
		80MG	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

Paragraph IV (Patent) Challenges for LURASIDONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
LATUDA	TABLET;ORAL	lurasidone hydrochloride	200603	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
Torrent	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208055-004	Jan 3, 2019		DISCN	No	No
Lupin Ltd	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208031-004	Jan 3, 2019		DISCN	No	No
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	AB	RX	Yes	No
Zydus Pharms	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208052-004	Mar 19, 2019		DISCN	No	No
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010	AB	RX	Yes	Yes					Y
Lupin Ltd	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208031-001	Jan 3, 2019		DISCN	No	No
Torrent	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208055-001	Jan 3, 2019		DISCN	No	No

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
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-003	Dec 7, 2011
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010

International Patents for lurasidone hydrochloride

Country	Patent Number	Estimated Expiration
Denmark	1652848
Spain	2326078
Hungary	S1400051
European Patent Office	1944030
Taiwan	I359020
Netherlands	300690
Australia	2004259305

Supplementary Protection Certificates for lurasidone hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1884242	551	Finland
1884242	251 5024-2014	Slovakia		PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
1884242	92550	Luxembourg		PRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327
1884242	C01884242/01	Switzerland		PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: SWISSMEDIC 62785 12.08.2013
1884242	122014000092	Germany		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	C 2014 038	Romania		PRODUCT NAME: LURASIDONA, OPTIONAL SUB FORMA BAZEI EI LIBERE SAU CA SARURIACCEPTABILE FARMACEUTIC ALE ACESTEIA, IN SPECIAL CLORHIDRAT DE LURASIDONA -C28H36N4O2S; NATIONAL AUTHORISATION NUMBER: EU/1/14/913; DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/913; DATE OF FIRST AUTHORISATION IN EEA: 20140321
1884242	1490057-5	Sweden		PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327