REXULTI Drug Patent Profile

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

Rexulti is a drug marketed by Otsuka and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in thirty-seven countries.

The generic ingredient in REXULTI is brexpiprazole. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brexpiprazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Rexulti

Rexulti was eligible for patent challenges on July 10, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 12, 2032. This may change due to patent challenges or generic licensing.

There have been twenty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (brexpiprazole), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for REXULTI

International Patents:	72
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	11
Patent Applications:	87
Drug Prices:	Drug price information for REXULTI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REXULTI
What excipients (inactive ingredients) are in REXULTI?	REXULTI excipients list
DailyMed Link:	REXULTI at DailyMed

See drug prices for REXULTI

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for REXULTI

NDA:

205422

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for REXULTI

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

Sponsor	Phase
Simon Fraser University	Phase 4
McGill University	Phase 4
University of Ottawa	Phase 4

See all REXULTI clinical trials

Pharmacology for REXULTI

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for REXULTI

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for REXULTI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REXULTI	Tablets	brexpiprazole	0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg	205422	18	2019-07-10

US Patents and Regulatory Information for REXULTI

REXULTI is protected by nine US patents and one FDA Regulatory Exclusivity.

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

Patents protecting REXULTI

FDA Regulatory Exclusivity protecting REXULTI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015		RX	Yes	No			Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-004	Jul 10, 2015		RX	Yes	Yes				Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015		RX	Yes	No			Y

EU/EMA Drug Approvals for REXULTI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V.	Rxulti	brexpiprazole	EMEA/H/C/003841 Treatment of schizophrenia.	Authorised	no	no	no	2018-07-26

International Patents for REXULTI

When does loss-of-exclusivity occur for REXULTI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

India

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

New Zealand

Poland

Portugal

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 REXULTI around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	2014013783	TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
European Patent Office	2767285	COMPRIMÉ COMPRENANT DE LA 7-[4-(4-BENZO[b]THIOPHÉN-4-YL-PIPÉRAZIN-1-YL) BUTOXY]-1H-QUINOLÉIN-2-ONE OU UN SEL DE CELLE-CI (TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF)
Mexico	2007012626	BENZOTIOFENOS SUSTITUIDOS CON PIPERAZINA PARA EL TRATAMIENTO DE TRASTORNOS MENTALES. (PIPERAZINE-SUBSTITUTED BENZOTHIOPHENES FOR TREATMENT OF MENTAL DISORDERS.)

Supplementary Protection Certificates for REXULTI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	18C0004	France		PRODUCT NAME: BREXPIPRAZOLE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025	LUC00086	Luxembourg		PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025	CR 2018 00028	Denmark		PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727