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Last Updated: May 17, 2024

BREXPIPRAZOLE - Generic Drug Details

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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
Unity Health Toronto	Phase 4

See all BREXPIPRAZOLE clinical trials

Generic filers with tentative approvals for BREXPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	2MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	1MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	0.5MG	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213562-002	Jan 31, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213570-003	Sep 26, 2022		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213512-001	Mar 17, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for BREXPIPRAZOLE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for BREXPIPRAZOLE

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Country	Patent Number	Title	Estimated Expiration
Denmark	2767285		⤷ Try a Trial
Argentina	053577	PIPERAZIN-BENZOTIOFENOS SUSTITUIDOS PARA EL TRATAMIENTO DE DESORDENES MENTALES	⤷ Try a Trial
Lithuania	2767285		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BREXPIPRAZOLE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	2018/034	Ireland	⤷ Try a Trial	PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1294 20180726; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2402)
1869025	C20180022 00264	Estonia	⤷ Try a Trial	PRODUCT NAME: BREKSPIPRASOOL;REG NO/DATE: EU/1/18/1294 30.07.2018
1869025	CR 2018 00028	Denmark	⤷ Try a Trial	PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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