Brexpiprazole

Overview

Brexpiprazole is an atypical antipsychotic used in the treatment of schizophrenia and as an adjunct in major depressive disorder. It acts as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors, and as an antagonist at serotonin 5-HT2A receptors.

API suppliers (22)

Suppliers of Brexpiprazole evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• HONOUR LAB LTDIndia1 active DMF GMP on record
• TAPI NL BVNetherlands1 active DMF
• MSN LIFE SCIENCES PRIVATE LIMITEDIndia1 active DMF GMP on record
• ZAKLADY FARMACEUTYCZNE POLPHARMA SA1 active DMF
• JUBILANT BIOSYS LTDIndia1 active DMF
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• Lupin LimitedIndia1 active DMF GMP on record
• Unichem Laboratories Ltd.India1 active DMF GMP on record
• RAKS PHARMA PVT LTDIndia1 active DMF
• Macleods Pharmaceuticals Ltd.India1 active DMF GMP on record
• Apotex Inc.Canada1 active DMF
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• Zhejiang Huahai Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• TOPHARMAN SHANDONG CO LTDChina1 active DMF
• Cipla USA, Inc.USA1 active DMF
• BEIJING HOPE PHARMACEUTICAL CO LTD1 active DMF
• ZHEJIANG GUOBANG PHARMACEUTICAL CO LTD1 active DMF
• MOREPEN LABORATORIES LTDIndia1 active DMF GMP on record
• HUADONG MEDICINE (XI'AN) BODYGUARD PHARMACEUTICAL CO LTD1 active DMF
• BIOPHORE INDIA PHARMACEUTICALS PVT LTD1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (12 approved US products), the latest listed US patent on Brexpiprazole expires 12 Apr 2033 and exclusivity 9 May 2028. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

3,5,5-trimethyl-1,3-oxazolidine-2,4-dione

Canonical SMILES

CC1(C(=O)N(C(=O)O1)C)C

InChIKey

IRYJRGCIQBGHIV-UHFFFAOYSA-N

Therapeutic areas