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-four patent family members in thirty-seven countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rexulti

A generic version of REXULTI was approved as brexpiprazole by OPTIMUS on October 25^th, 2023.

Summary for REXULTI

International Patents:	74
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	11
Patent Applications:	319
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

Recent Clinical Trials for REXULTI

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

Sponsor	Phase
Baycrest	Phase 4
University of British Columbia	Phase 4
Queen's University	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 two FDA Regulatory Exclusivities.

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	205422-004	Jul 10, 2015	AB	RX	Yes	Yes				Y	Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015	AB	RX	Yes	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015	AB	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

Cyprus

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
China	107397730	含有7‑[4‑(4‑苯并[b]噻吩‑4‑基‑哌嗪‑1‑基)丁氧基]‑1H‑喹啉‑2‑酮或其盐的片剂 (TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF)
Germany	602006019838
Cyprus	2018028

Supplementary Protection Certificates for REXULTI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	PA2018509,C1869025	Lithuania		PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	LUC00086	Luxembourg		PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025	C201830050	Spain		PRODUCT NAME: BREXPIPRAZOL O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1294; DATE OF AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1294; DATE OF FIRST AUTHORISATION IN EEA: 20180726