BRIVARACETAM - Generic Drug Details

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What are the generic sources for brivaracetam and what is the scope of freedom to operate?

Brivaracetam is the generic ingredient in two branded drugs marketed by Ucb Inc, Aurobindo Pharma Ltd, Lupin Ltd, Sunshine, and Zydus Pharms, and is included in seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brivaracetam has one hundred and seventy-three patent family members in forty-five countries.

One supplier is listed for this compound. There are six tentative approvals for this compound.

Summary for BRIVARACETAM

International Patents:	173
US Patents:	2
Tradenames:	2
Applicants:	5
NDAs:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	44
Patent Applications:	1,276
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRIVARACETAM
What excipients (inactive ingredients) are in BRIVARACETAM?	BRIVARACETAM excipients list
DailyMed Link:	BRIVARACETAM at DailyMed

Recent Clinical Trials for BRIVARACETAM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, Los Angeles	Phase 1/Phase 2
University of Minnesota	Phase 3
GX pharma technology (beijing) Co., Ltd	Phase 1

See all BRIVARACETAM clinical trials

Generic filers with tentative approvals for BRIVARACETAM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	75mg	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	50mg	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	25mg	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BRIVARACETAM

Mechanism of Action	Epoxide Hydrolase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BRIVARACETAM

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BRIVARACETAM

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 BRIVARACETAM

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Glossary

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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	205836-002	May 12, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Zydus Pharms	BRIVARACETAM	brivaracetam	TABLET;ORAL	214501-003	Oct 3, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214848-002	Jan 6, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sunshine	BRIVARACETAM	brivaracetam	TABLET;ORAL	214748-005	Jun 9, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 BRIVARACETAM

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for BRIVARACETAM

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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 BRIVARACETAM

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Country	Patent Number	Title	Estimated Expiration
Bulgaria	65923		⤷ Sign Up
European Patent Office	1265862	DERIVES DE 2-OXO-1-PYRROLIDINE, PROCEDES DE PREPARATION ET UTILISATIONS DESDITS DERIVES (2-OXO-1-PYRROLIDINE DERIVATIVES, PROCESSES FOR PREPARING THEM AND THEIR USES)	⤷ Sign Up
Mexico	2011007267	COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN DERIVADOS DE 2-OXO-1-PIRROLIDINA. (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES.)	⤷ Sign Up
Croatia	P20141006		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BRIVARACETAM

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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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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