Details for New Drug Application (NDA): 205836
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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 two 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: | 2 |
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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 12, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 10,729,653 | Patent Expiration: | Apr 9, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 6,911,461 | Patent Expiration: | Feb 21, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | May 12, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 10,729,653 | Patent Expiration: | Apr 9, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 205836
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-003 | May 12, 2016 | 8,492,416 | ⤷ Get Started Free |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-005 | May 12, 2016 | 6,784,197 | ⤷ Get Started Free |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-004 | May 12, 2016 | 8,492,416 | ⤷ Get Started Free |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-002 | May 12, 2016 | 6,784,197 | ⤷ Get Started Free |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-003 | May 12, 2016 | 6,784,197 | ⤷ Get Started Free |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-001 | May 12, 2016 | 6,784,197 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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