BRIVIACT Drug Patent Profile
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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® Generic Entry Outlook for Briviact
Briviact was eligible for patent challenges on May 12, 2020.
There have been two patent litigation cases 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.
There are six tentative approvals for the generic drug (brivaracetam), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for BRIVIACT
| International Patents: | 173 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 42 |
| Clinical Trials: | 14 |
| Patent Applications: | 815 |
| 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 |
|---|---|
| University of California, Los Angeles | Phase 1/Phase 2 |
| GX pharma technology (beijing) Co., Ltd | Phase 1 |
| Overseas Pharmaceuticals, Ltd. | Phase 1 |
Pharmacology for BRIVIACT
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-005 | May 12, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-001 | May 12, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-003 | May 12, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 | 205836-002 | May 12, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-003 | May 12, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-003 | May 12, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-001 | May 12, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 1007161
Patent: composição farmacêutica oral, e processo para preparar uma composição
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 47395
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DES DERIVES DE 2-OXO-1-PYRROLIDINE (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2292071
Estimated Expiration: ⤷ Sign Up
Patent: 4083328
Patent: Pharmaceutical Compositions Comprising 2-Oxo-1-Pyrrolidine Derivatives
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0141006
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 15673
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 91349
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2057
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ БРИВАРАЦЕТАМ (PHARMACEUTICAL COMPOSITIONS COMPRISING BRIVARACETAM)
Estimated Expiration: ⤷ Sign Up
Patent: 1101116
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ ПРОИЗВОДНЫЕ 2-ОКСО-1-ПИРРОЛИДИНА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 91349
Patent: Compositions pharmaceutiques comprenant des dérivés de 2-oxo-1-pyrrolidine (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 61988
Patent: 包含 -氧代- -吡咯烷衍生物的藥物組合物 (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES 2--1-)
Estimated Expiration: ⤷ Sign Up
Patent: 98287
Patent: 包含 -氧代- -吡咯烷衍生物的藥物組合物 (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES 2--1-)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3545
Patent: תכשירי רוקחות המכילים תולדות 2-אוקסו-1-פירולידין (Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 76401
Estimated Expiration: ⤷ Sign Up
Patent: 12516302
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11007267
Patent: COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN DERIVADOS DE 2-OXO-1-PIRROLIDINA. (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 927
Patent: FARMACEUTSKE KOMPOZICIJE KOJE SADRZE 2-OKSO-1-PIROLIDIN DERIVATE (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 91349
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 91349
Estimated Expiration: ⤷ Sign Up
San Marino
Patent: 01400155
Patent: Composizioni farmaceutiche comprendenti derivati di 2-osso-1-pirrolidina
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 554
Patent: FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE 2-OKSO-1-PIROLIDIN DERIVATE (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 91349
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1640164
Estimated Expiration: ⤷ Sign Up
Patent: 120008022
Patent: PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 11047
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Denmark | 1263727 | ⤷ Sign Up | |
| Israel | 170181 | (4R) AND (4S)-DIASTEREOISOMERS OF (2S)-2-[OXY-4-PROPYLPYRROLIDINYL]BUTANAMIDE, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM AND THEIR USE FOR PREPARING MEDICAMENTS | ⤷ Sign Up |
| Canada | 2401048 | DERIVES DE 2-OXO-1-PYRROLIDINE, PROCEDE DE PREPARATION ET UTILISATIONS CORRESPONDANTES (2-OXO-1-PYRROLIDINE DERIVATIVES, PROCESS FOR PREPARING THEM AND THEIR USES) | ⤷ Sign Up |
| Bulgaria | 65803 | ⤷ Sign Up | |
| Eurasian Patent Organization | 201101116 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ ПРОИЗВОДНЫЕ 2-ОКСО-1-ПИРРОЛИДИНА | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BRIVIACT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1452524 | 10/2016 | Austria | ⤷ Sign Up | PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 (MITTEILUNG) 20160118 |
| 1452524 | CA 2016 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118 |
| 1452524 | 122016000030 | Germany | ⤷ Sign Up | PRODUCT NAME: BRIVARACETAM ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1073 20160114 |
| 2391349 | C20160006 00188 | Estonia | ⤷ Sign Up | PRODUCT NAME: BRIVARATSETAAM;REG NO/DATE: EU/1/15/1073 18.01.2016 |
| 1452524 | 1690009-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073 20150114 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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