You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 11, 2025

Details for New Drug Application (NDA): 213731

✉ Email this page to a colleague

« Back to Dashboard

NDA 213731 describes BREXPIPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal, Anda Repository, Apotex, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Lupin Ltd, Sandoz, Teva Pharms Usa Inc, and Zydus Pharms, and is included in twelve NDAs. It is available from two suppliers. Additional details are available on the BREXPIPRAZOLE profile page.

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

Summary for 213731

Tradename:	BREXPIPRAZOLE
Applicant:	Apotex
Ingredient:	brexpiprazole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Feb 24, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Feb 24, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Feb 24, 2025	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.