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Details for New Drug Application (NDA): 205836
» See Plans and Pricing
NDA 205836 describes BRIVIACT, which is a drug marketed by Ucb Inc and is included in three NDAs. It is available from one supplier. There are four 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.
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 205836
| Tradename: | BRIVIACT |
| Applicant: | Ucb Inc |
| Ingredient: | brivaracetam |
| Patents: | 4 |
Generic Entry Opportunity Date for 205836
Generic Entry Date for 205836*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*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: 205836
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
Suppliers and Packaging for NDA: 205836
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIVIACT | brivaracetam | TABLET;ORAL | 205836 | NDA | UCB, Inc. | 50474-370 | 50474-370-66 | 1 BOTTLE in 1 CARTON (50474-370-66) > 60 TABLET, FILM COATED in 1 BOTTLE |
| BRIVIACT | brivaracetam | TABLET;ORAL | 205836 | NDA | UCB, Inc. | 50474-470 | 50474-470-09 | 100 BLISTER PACK in 1 CARTON (50474-470-09) > 1 TABLET, FILM COATED in 1 BLISTER PACK |
Paragraph IV (Patent) Challenges for 205836
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BRIVIACT | TABLET;ORAL | brivaracetam | 205836 | 2020-05-12 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 12, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 12, 2021 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
| Patent: | Start Trial | Patent Expiration: | Apr 9, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Feb 21, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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