LATUDA Drug Patent Profile

When do Latuda patents expire, and when can generic versions of Latuda launch?

Latuda is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-eight patent family members in twenty-four countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Latuda

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

Summary for LATUDA

International Patents:	68
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	24
Patent Applications:	916
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LATUDA
Drug Sales Revenues:	Drug sales revenues for LATUDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LATUDA
What excipients (inactive ingredients) are in LATUDA?	LATUDA excipients list
DailyMed Link:	LATUDA at DailyMed

See drug prices for LATUDA

See drug sales revenues for LATUDA

Recent Clinical Trials for LATUDA

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

Sponsor	Phase
New York State Psychiatric Institute	Phase 4
Columbia University	Phase 4
Astellas Pharma Global Development, Inc.	Phase 2

See all LATUDA clinical trials

Pharmacology for LATUDA

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for LATUDA

N05AE	Indole derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for LATUDA

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 LATUDA

LATUDA is protected by eleven US patents.

Patents protecting LATUDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	AB	RX	Yes	No					Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	AB	RX	Yes	No					Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No					Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No					Y

Expired US Patents for LATUDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	200603-001	Oct 28, 2010
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013

International Patents for LATUDA

When does loss-of-exclusivity occur for LATUDA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

France

Hong Kong

Hungary

Japan

Luxembourg

Mexico

Netherlands

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LATUDA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	6470164
Spain	2535478
Japan	WO2006126681	医薬品組成物
China	1832946	Process for producing imide compound
Greece	3026697

Supplementary Protection Certificates for LATUDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1884242	251 5024-2014	Slovakia		PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
1884242	132014902294693	Italy		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
1884242	2014/051	Ireland		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	C300690	Netherlands		PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242	C01884242/01	Switzerland		FORMER OWNER: SUMITOMO DAINIPPON PHARMA CO., LTD., JP