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briviact Drug Profile
» See Plans and Pricing
Which patents cover Briviact, and what generic alternatives are available?
Briviact is a drug marketed by Ucb Inc and is included in three NDAs. There are four patents protecting this drug.
This drug has one hundred and seventy-three patent family members in forty-five countries.
The generic ingredient in BRIVIACT is brivaracetam. One supplier is listed for this compound. Additional details are available on the brivaracetam profile page.
US ANDA Litigation and Generic Entry Outlook for Briviact
Briviact was eligible for patent challenges on May 12, 2020.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 21, 2026. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for briviact
| International Patents: | 173 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 31 |
| Clinical Trials: | 6 |
| Patent Applications: | 739 |
| Drug Prices: | Drug price information for briviact |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for briviact |
| What excipients (inactive ingredients) are in briviact? | briviact excipients list |
| DailyMed Link: | briviact at DailyMed |
Generic Entry Opportunity Date for briviact
Generic Entry Dates for briviact*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
Generic Entry Dates for briviact*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL |
Generic Entry Dates for briviact*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for briviact
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| UCB Biopharma SRL | Phase 3 |
| UCB Biopharma S.P.R.L. | Phase 3 |
| UCB Biopharma S.P.R.L. | Phase 2 |
Pharmacology for briviact
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
Paragraph IV (Patent) Challenges for BRIVIACT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BRIVIACT | TABLET;ORAL | brivaracetam | 205836 | 2020-05-12 |
| BRIVIACT | SOLUTION;INTRAVENOUS | brivaracetam | 205837 | 2020-05-12 |
| BRIVIACT | SOLUTION;ORAL | brivaracetam | 205838 | 2020-05-12 |
US Patents and Regulatory Information for briviact
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-005 | May 12, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-004 | May 12, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-005 | May 12, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for briviact
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-001 | May 12, 2016 | Start Trial | Start Trial |
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | Start Trial | Start Trial |
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for briviact
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Malaysia | 140593 | Start Trial |
| Hungary | 0204526 | Start Trial |
| Mexico | PA02008206 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for briviact
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1452524 | 10/2016 | Austria | Start Trial | PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 (MITTEILUNG) 20160118 |
| 1452524 | 1690009-4 | Sweden | Start Trial | PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073 20150114 |
| 1265862 | PA2016013,C1265862 | Lithuania | Start Trial | PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
