Brexpiprazole - Generic Drug Details

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

Brexpiprazole is the generic ingredient in two branded drugs marketed by Sandoz Inc, Teva Pharms Usa Inc, and Otsuka, and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for brexpiprazole

International Patents:	72
US Patents:	6
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	72
Patent Applications:	121
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
Queen's University	Phase 4

See all brexpiprazole clinical trials

Generic filers with tentative approvals for BREXPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
		4MG	TABLET;ORAL
		3MG	TABLET;ORAL
		2MG	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
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015	AB	RX	Yes	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-006	Jul 10, 2015	AB	RX	Yes	No
Teva Pharms Usa Inc	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213692-001	Aug 11, 2022	AB	RX	No	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	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
Japan	6084161
Luxembourg	C00086
Poland	2767285
South Africa	201402333	TABLET INCLUDING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN -1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
China	103889425	TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF

Supplementary Protection Certificates for brexpiprazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	2018C/037	Belgium		PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025	303 50013-2018	Slovakia		PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025	18C0004	France		PRODUCT NAME: BREXPIPRAZOLE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025	SPC/GB18/038	United Kingdom		PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/18/1294/001(NI) 20180730; UK PLGB 506970019 20180730; UK PLGB 506970020 20180730; UK PLGB 506970021 20180730; UK PLGB 506970022 20180730; UK PLGB 506970023 20180730; UK EU/1/18/1294/007(NI) 20180730; UK EU/1/18/1294/008(NI) 20180730; UK EU/1/18/1294/009(NI) 20180730; UK EU/1/18/1294/010(NI) 20180730; UK EU/1/18/1294/011(NI) 20180730; UK PLGB 506970024 20180730; UK EU/1/18/1294/002(NI) 20180730; UK EU/1/18/1294/003(NI) 20180730; UK EU/1/18/1294/004(NI) 20180730; UK EU/1/18/1294/005(NI) 20180730; UK EU/1/18/1294/006(NI) 20180730
1869025	LUC00086	Luxembourg		PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730