BREXPIPRAZOLE - Generic Drug Details

What are the generic drug sources for brexpiprazole and what is the scope of freedom to operate?

Brexpiprazole is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Lupin Ltd, Optimus, Sandoz, Teva Pharms Usa Inc, Zydus Pharms, and Otsuka, and is included in eleven NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brexpiprazole has seventy-four patent family members in thirty-seven countries.

There are eight drug master file entries for brexpiprazole. Five suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for BREXPIPRAZOLE

International Patents:	74
US Patents:	6
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	72
Patent Applications:	129
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREXPIPRAZOLE
What excipients (inactive ingredients) are in BREXPIPRAZOLE?	BREXPIPRAZOLE excipients list
DailyMed Link:	BREXPIPRAZOLE at DailyMed

Recent Clinical Trials for BREXPIPRAZOLE

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

Sponsor	Phase
H. Lundbeck A/S	Phase 4
Iqvia Pty Ltd	Phase 1
McMaster University	Phase 4

See all BREXPIPRAZOLE clinical trials

Generic filers with tentative approvals for BREXPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
		0.5MG	TABLET;ORAL
		0.25MG	TABLET;ORAL
		4MG	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 BREXPIPRAZOLE

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for BREXPIPRAZOLE

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 BREXPIPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213570-005	Sep 26, 2022		DISCN	No	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-002	Jul 10, 2015	AB	RX	Yes	No			Y
Teva Pharms Usa Inc	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213692-003	Aug 11, 2022		DISCN	No	No
Ajanta Pharma Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213718-003	Feb 3, 2023		DISCN	No	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015	AB	RX	Yes	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015	AB	RX	Yes	No				Y	Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015	AB	RX	Yes	No			Y

EU/EMA Drug Approvals for BREXPIPRAZOLE

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 BREXPIPRAZOLE

Country	Patent Number	Title	Estimated Expiration
Australia	2006237905	Piperazine-substituted benzothiophenes for treatment of mental disorders
South Korea	100937623
South Africa	200708686	Piperazine-substituted benzothiophenes for treatment of mental disorders
Taiwan	I320783
India	855DEN2012
Israel	185909	תרכובות המכילות טבעות בנזו[b]תיופן, פיפראזין וטבעת קווינולין/איזוקווינולין אשר אופציונלית עברה הידרוגנציה, תהליך להכנתן ותכשירי רוקחות המכילים אותן לטיפול בהפרעות של מערכת העצבים המרכזית (Compounds comprising benzo[b]thiophene, piperazine and optionally hydrogenated quinoline/isoquinoline rings, process for their preparation and pharmaceutical compositions comprising them for treating cns disorders)
Cyprus	1111206

Supplementary Protection Certificates for BREXPIPRAZOLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	PA2018509	Lithuania		PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	CA 2018 00028	Denmark		PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025	PA2018509,C1869025	Lithuania		PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	300946	Netherlands		PRODUCT NAME: BREXPIPRAZOLE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/18/1294 20180727
1869025	303 50013-2018	Slovakia		PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025	C 2018 036	Romania		PRODUCT NAME: BREXPIPRAZOL SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1294; DATE OF NATIONAL AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1294; DATE OF FIRST AUTHORISATION IN EEA: 20180726
1869025	1890028-2	Sweden		PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730