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

Last Updated: April 26, 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-eight 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.

Summary for LURASIDONE HYDROCHLORIDE

International Patents:	68
US Patents:	9
Tradenames:	2
Applicants:	18
NDAs:	18
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	79
Patent Applications:	137
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
First Affiliated Hospital of Zhejiang University	Phase 4
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Phase 4
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
⤷ Try a Trial	⤷ Try a Trial	120MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	80MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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 Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	213248-005	May 13, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal Pharms Co	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208002-001	Jan 3, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Invagen Pharms	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208028-005	Jan 3, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208052-001	Mar 19, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 Try a Trial
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	⤷ Try a Trial	⤷ Try a Trial
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	⤷ Try a Trial	⤷ Try a Trial
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010	⤷ Try a Trial	⤷ Try a Trial
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010	⤷ Try a Trial	⤷ Try a Trial
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LURASIDONE HYDROCHLORIDE

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Taiwan	I359020		⤷ Try a Trial
Canada	2814828	PROCEDE DE TRAITEMENT DE TROUBLES MENTAUX (METHOD OF TREATMENT FOR MENTAL DISORDERS)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006126681		⤷ Try a Trial
Japan	2016094440	精神疾患の治療方法 (METHODS FOR TREATING MENTAL DISEASES)	⤷ Try a Trial
Japan	4745661		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LURASIDONE HYDROCHLORIDE

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1884242	92550	Luxembourg	⤷ Try a Trial	PRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327
1884242	251 5024-2014	Slovakia	⤷ Try a Trial	PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
1884242	300690	Netherlands	⤷ Try a Trial	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1884242	CR 2014 00049	Denmark	⤷ Try a Trial	PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327
1884242	132014902294693	Italy	⤷ Try a Trial	PRODUCT NAME: LURASIDONE, OPZIONALMENTE IN FORMA DI BASE LIBERA O DI SUOI SALI FARMACEUTICAMENTE ACCETTABILI(LATUDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/913, 20140321
>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.