LURASIDONE HYDROCHLORIDE Drug Patent Profile

Which patents cover Lurasidone Hydrochloride, and what generic alternatives are available?

Lurasidone Hydrochloride is a drug marketed by 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 seventeen NDAs.

The generic ingredient in LURASIDONE HYDROCHLORIDE is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lurasidone Hydrochloride

A generic version of LURASIDONE HYDROCHLORIDE was approved as lurasidone hydrochloride by ACCORD HLTHCARE on January 3^rd, 2019.

Summary for LURASIDONE HYDROCHLORIDE

US Patents:	0
Applicants:	17
NDAs:	17
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	79
Patent Applications:	64
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LURASIDONE HYDROCHLORIDE
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
Bracket, Inc.	Phase 2/Phase 3

See all LURASIDONE HYDROCHLORIDE clinical trials

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

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	208055-003	Jan 3, 2019	AB	RX	No	No
Lupin Ltd	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208031-002	Jan 3, 2019	AB	RX	No	No
Dr Reddys	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208047-002	Aug 24, 2021	AB	RX	No	No
Macleods Pharms Ltd	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	212124-005	Jun 9, 2023	AB	RX	No	No
Sun Pharm	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208066-001	Jan 4, 2019	AB	RX	No	No
Macleods Pharms Ltd	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	212124-001	Jun 9, 2023	AB	RX	No	No