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Generated: November 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205837

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NDA 205837 describes BRIVIACT, which is a drug marketed by Ucb Inc and is included in three NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the BRIVIACT profile page.

The generic ingredient in BRIVIACT is brivaracetam. One supplier is listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 205837
Tradename:BRIVIACT
Applicant:Ucb Inc
Ingredient:brivaracetam
Patents:3
Generic Entry Opportunity Date for 205837
Generic Entry Date for 205837*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 205837
Mechanism of ActionEpoxide Hydrolase Inhibitors
Suppliers and Packaging for NDA: 205837
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIVIACT brivaracetam SOLUTION;INTRAVENOUS 205837 NDA UCB, Inc. 50474-970 50474-970-75 10 VIAL, GLASS in 1 CARTON (50474-970-75) > 5 mL in 1 VIAL, GLASS (50474-970-63)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/5ML (10MG/ML)
Approval Date:May 12, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:May 12, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Feb 21, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL ONSET SEIZURES IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY
Patent:➤ Try a Free TrialPatent Expiration:Feb 21, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Dow
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McKesson
Healthtrust
Citi

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