Last Updated: September 24, 2026

Details for New Drug Application (NDA): 214875


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NDA 214875 describes BRIVARACETAM, which is a drug marketed by Hainan Poly, Micro Labs, MSN, Shandong, Alkem Labs Ltd, Aurobindo Pharma, Lupin, Regcon Holdings, Zhejiang Poly Pharm, Apotex, Aurobindo Pharma Ltd, Centaur Pharms Pvt, Sciegen Pharms, Sunshine, and Zydus Pharms, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the BRIVARACETAM profile page.

The generic ingredient in BRIVARACETAM is brivaracetam. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 214875
Tradename:BRIVARACETAM
Applicant:Apotex
Ingredient:brivaracetam
Patents:0
Pharmacology for NDA: 214875
Mechanism of ActionEpoxide Hydrolase Inhibitors
Suppliers and Packaging for NDA: 214875
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIVARACETAM brivaracetam TABLET;ORAL 214875 ANDA Apotex Corp. 60505-4723 60505-4723-6 60 TABLET in 1 BOTTLE (60505-4723-6)
BRIVARACETAM brivaracetam TABLET;ORAL 214875 ANDA Apotex Corp. 60505-4724 60505-4724-6 60 TABLET in 1 BOTTLE (60505-4724-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 23, 2026TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Feb 23, 2026TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 23, 2026TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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