briviact Drug Patent Profile
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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 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 |
Overseas Pharmaceuticals, Ltd. | Phase 1 |
GX pharma technology (beijing) Co., 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.
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 | 6,911,461 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-005 | May 12, 2016 | RX | Yes | Yes | 6,911,461 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-001 | May 12, 2016 | RX | Yes | No | 10,729,653 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | RX | Yes | Yes | 6,911,461 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
>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 | 6,784,197 | ⤷ Subscribe |
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-002 | May 12, 2016 | 8,492,416 | ⤷ Subscribe |
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-004 | May 12, 2016 | 8,492,416 | ⤷ Subscribe |
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | 6,784,197 | ⤷ Subscribe |
>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: ⤷ Subscribe
Brazil
Patent: 1007161
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 47395
Estimated Expiration: ⤷ Subscribe
China
Patent: 2292071
Estimated Expiration: ⤷ Subscribe
Patent: 4083328
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0141006
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 15673
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 91349
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 2057
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ БРИВАРАЦЕТАМ (PHARMACEUTICAL COMPOSITIONS COMPRISING BRIVARACETAM)
Estimated Expiration: ⤷ Subscribe
Patent: 1101116
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ ПРОИЗВОДНЫЕ 2-ОКСО-1-ПИРРОЛИДИНА
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Israel
Patent: 3545
Patent: תכשירי רוקחות המכילים תולדות 2-אוקסו-1-פירולידין (Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 76401
Estimated Expiration: ⤷ Subscribe
Patent: 12516302
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 11007267
Patent: COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN DERIVADOS DE 2-OXO-1-PIRROLIDINA. (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES.)
Estimated Expiration: ⤷ Subscribe
Montenegro
Patent: 927
Patent: FARMACEUTSKE KOMPOZICIJE KOJE SADRZE 2-OKSO-1-PIROLIDIN DERIVATE (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES)
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 91349
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 91349
Estimated Expiration: ⤷ Subscribe
San Marino
Patent: 01400155
Patent: Composizioni farmaceutiche comprendenti derivati di 2-osso-1-pirrolidina
Estimated Expiration: ⤷ Subscribe
Serbia
Patent: 554
Patent: FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE 2-OKSO-1-PIROLIDIN DERIVATE (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES)
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 91349
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1640164
Estimated Expiration: ⤷ Subscribe
Patent: 120008022
Patent: PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 11047
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Hong Kong | 1161988 | 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-) | ⤷ Subscribe |
Iceland | 7918 | ⤷ Subscribe | |
Spain | 2248307 | ⤷ Subscribe | |
Iceland | 2176 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for briviact
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2391349 | C20160006 00188 | Estonia | ⤷ Subscribe | PRODUCT NAME: BRIVARATSETAAM;REG NO/DATE: EU/1/15/1073 18.01.2016 |
1452524 | C01452524/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016 |
1265862 | PA2016013,C1265862 | Lithuania | ⤷ Subscribe | PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114 |
1452524 | 300815 | Netherlands | ⤷ Subscribe | PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Briviact Market Analysis and Financial Projection Experimental
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