BRIVIACT Drug Patent Profile
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
When do Briviact patents expire, and what generic alternatives are available?
Briviact is a drug marketed by Ucb Inc and is included in three NDAs. There are two patents protecting this drug and three Paragraph IV challenges.
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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Briviact
A generic version of BRIVIACT was approved as brivaracetam by LUPIN LTD on December 20th, 2022.
Summary for BRIVIACT
International Patents: | 173 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 13 |
Patent Applications: | 510 |
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 |


Recent Clinical Trials for BRIVIACT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
GX pharma technology (beijing) Co., Ltd | Phase 1 |
Overseas Pharmaceuticals, Ltd. | Phase 1 |
UCB Biopharma SRL | Phase 1 |
Pharmacology for BRIVIACT
Mechanism of Action | Epoxide Hydrolase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for BRIVIACT
Paragraph IV (Patent) Challenges for BRIVIACT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BRIVIACT | Tablets | brivaracetam | 10 mg, 25 mg, 50 mg, 75 mg and 100 mg | 205836 | 7 | 2020-05-12 |
BRIVIACT | Injection | brivaracetam | 50 mg/5 mL | 205837 | 2 | 2020-05-12 |
BRIVIACT | Oral Solution | brivaracetam | 10 mg/mL | 205838 | 1 | 2020-05-12 |
US Patents and Regulatory Information for BRIVIACT
BRIVIACT is protected by four US patents and one FDA Regulatory Exclusivity.
Patents protecting BRIVIACT
Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY
2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARTIAL ONSET SEIZURES IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY
2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
FDA Regulatory Exclusivity protecting BRIVIACT
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
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 | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-005 | May 12, 2016 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-001 | May 12, 2016 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-003 | May 12, 2016 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a 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 | SOLUTION;ORAL | 205838-001 | May 12, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-005 | May 12, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-002 | May 12, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BRIVIACT
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
UCB Pharma SA | Briviact (in Italy: Nubriveo) | brivaracetam | EMEA/H/C/003898 Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy. |
Authorised | no | no | no | 2016-01-13 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for BRIVIACT
When does loss-of-exclusivity occur for BRIVIACT?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 10215646
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 1007161
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 47395
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2292071
Estimated Expiration: ⤷ Try a Trial
Patent: 4083328
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0141006
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 15673
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 91349
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 2057
Estimated Expiration: ⤷ Try a Trial
Patent: 1101116
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 91349
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 61988
Estimated Expiration: ⤷ Try a Trial
Patent: 98287
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 3545
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 76401
Estimated Expiration: ⤷ Try a Trial
Patent: 12516302
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 11007267
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 927
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 91349
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 91349
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01400155
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 554
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 91349
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1640164
Estimated Expiration: ⤷ Try a Trial
Patent: 120008022
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 11047
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering BRIVIACT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Romania | 121597 | DERIVATI DE 2-OXO-1-PIROLIDINA, COMPOZITII FARMACEUTICE SI UTILIZAREA LOR (2-OXO-PYRROLIDINE DERIVATIVES, PHARMACEUTICAL COMPOSITIONS AND USE THEREOF) | ⤷ Try a Trial |
New Zealand | 520448 | 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses | ⤷ Try a Trial |
Iceland | 2176 | ⤷ Try a Trial | |
Austria | 488500 | ⤷ Try a Trial | |
Montenegro | 00595 | 2-OKSO-1-PIROLIDINSKI DERIVATI, POSTUPCI ZA NJIHOVO DOBIJANJE I NJIHOVE PRIMENE (2-OXO-1-PYRROLIDINE DERIVATIVES, PROCESSES FOR PREPARING THEM AND THEIR USES) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BRIVIACT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1452524 | 1690009-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073 20150114 |
1452524 | 16C1001 | France | ⤷ Try a Trial | PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118 |
1452524 | 122016000030 | Germany | ⤷ Try a Trial | PRODUCT NAME: BRIVARACETAM ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1073 20160114 |
1452524 | C01452524/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016 |
1265862 | PA2016013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |