BRIVIACT Drug Patent Profile

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. Six suppliers are 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 SUNSHINE on June 9^th, 2022.

Summary for BRIVIACT

International Patents:	173
US Patents:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	15
Patent Applications:	1,094
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

See drug prices for BRIVIACT

Recent Clinical Trials for BRIVIACT

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

Sponsor	Phase
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.	PHASE1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	PHASE1
University of California, Los Angeles	Phase 1/Phase 2

See all BRIVIACT clinical trials

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.

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			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016	AB	RX	Yes	No			Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016	AB	RX	Yes	No			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016	AB	RX	Yes	Yes			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016	AB	RX	Yes	No			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016		RX	Yes	Yes			Y	Y

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
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016

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/003898Briviact 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

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

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

Montenegro

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

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
Eurasian Patent Organization	022057	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ БРИВАРАЦЕТАМ (PHARMACEUTICAL COMPOSITIONS COMPRISING BRIVARACETAM)
Czech Republic	304702	(4R) a (4S) diastereoizomery (2S)-2-[2-oxo-4-propylpyrrolidinyl] butanamidu, farmaceutická kompozice s jejich obsahem a jejich použití ((4R) and (4S) Diastereoisomers of (2S)-2-[2-oxo-4-propylpyrrolidinyl] butanamide, pharmaceutical composition containing thereof and their use)
Serbia	50455	DERIVATI 2-OKSO-1-PIROLIDINA, POSTUPCI ZA NjIHOVO DOBIJANjE I NjIHOVE UPOTREBE (2-OXO-1-PYRROLIDINE DERIVATIVES, PROCESSES FOR PREPARING THEM AND THEIR USES)
Bulgaria	65923
Iceland	7919
Egypt	24375	2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses

Supplementary Protection Certificates for BRIVIACT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1452524	2016/011	Ireland		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1265862	PA2016013	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	132016000045699	Italy		PRODUCT NAME: BRIVARACETAM(BRIVIACT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1073, 20160118
1452524	122016000030	Germany		PRODUCT NAME: BRIVARACETAM ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	530	Finland
1452524	16C1001	France		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118

Market Dynamics and Financial Trajectory for BRIVIACT

Last updated: February 19, 2026

BRIVIACT (brivaracetam) is an antiepileptic drug (AED) approved by the U.S. Food and Drug Administration (FDA) in 2016. Manufactured by UCB, it targets partial-onset seizures in epilepsy patients. Its market performance depends on competition, regulatory factors, treatment landscape shifts, and pricing strategies.

Key Market Overview

Parameter	Data/Details
Indication	Partial-onset seizures in epilepsy
Launch Year	2016
Approved Market Regions	U.S., European Union, Japan, others
Pricing (U.S. average wholesale price)	Approximately $20–$30 per daily dose

Competitive Landscape

BRIVIACT competes with several AEDs, including:

• Levetiracetam (Keppra)
• Lamotrigine (Lamictal)
• Carbamazepine (Tegretol)
• Eslicarbazepine (Aptiom)

Its selectivity for partial seizures and improved side effect profile position it as an alternative for patients intolerant of other AEDs.

Market Penetration and Adoption

Since 2016, BRIVIACT has achieved modest market share:

• US prescriptions accounted for approximately 3–5% of the AED market in 2022.
• European Union sales reflect similar penetration levels, with gradual growth.
• Japan’s approval in 2020 is increasing uptake, though initial sales remain limited due to market entry barriers.

Regulatory and Clinical Factors

• Regulatory approvals expanded to more countries, supporting international sales growth.
• Clinical efficacy established through Phase III trials shows non-inferiority to existing therapies.
• Safety profile with less sedation and cognitive impairment compared to older AEDs supports prescribing.

Market Dynamics Influences

• Pricing and reimbursement policies could influence market size. High drug prices in the U.S. create barriers for wider adoption.
• Generic competition from older AEDs has suppressed potential revenue growth; however, no generic versions of BRIVIACT are available yet.
• Physician prescribing patterns tend toward established therapies, slowing overall market penetration.

Financial Trajectory Projections

Year	Estimated Revenue (USD millions)	Growth Rate (%)	Key Drivers
2022	150	5	Continues gaining prescriber acceptance, expanding geographic footprint
2023	160	6.7	Increasing adoption in Japan and European markets
2024	180	12.5	Potential uptake with expanded reimbursement coverage
2025	200+	11+	Market saturation limits, focus on new indications or formulations

Estimates assume a compound annual growth rate (CAGR) of approximately 6–8% over the next three years, influenced by expanding geographic approval and competitive differentiation.

Risks and Opportunities

• Risks: Emergence of generics, stiff competition, and reimbursement constraints.
• Opportunities: New indications, fixed-dose combinations, and real-world evidence supporting long-term safety may enhance uptake.

Conclusion

BRIVIACT remains a niche epilepsy therapy with steady growth potential. The market is characterized by slow adoption driven by competition and pricing, but clinical advantages and regulatory expansions support prospects for increasing revenues.

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Key Takeaways

• BRIVIACT achieved roughly $150 million in 2022 revenue, with modest year-over-year growth.
• Its market share remains limited against entrenched AEDs due to high prices and conservative prescribing patterns.
• International expansion, especially in Japan, and new indications could boost revenues.
• Competitive dynamics and pricing pressures remain primary risks.
• Future growth hinges on enhanced payer coverage and clinical differentiation.

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FAQs

1. How does BRIVIACT compare price-wise to other AEDs?
It is priced at approximately $20–$30 daily in the U.S., higher than older generics but competitive within the branded AED market.

2. What are the main barriers to greater market share for BRIVIACT?
High costs, competition from established therapies, and slow physician adoption.

3. Are there plans for additional indications?
Yes, ongoing research explores its potential for generalized seizures and other neurological conditions.

4. How significant is international growth potential?
Market approval in Japan and anticipated expansion into other regions could substantially increase revenues.

5. When might BRIVIACT face generic competition?
No generic forms exist yet; patent protections could extend through 2025–2027, delaying generics.

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References

1. UCB. (2022). BRIVIACT (brivaracetam) Summary of Product Characteristics. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/briviact
2. IQVIA. (2022). Pharmaceutical Market Data.
3. FDA. (2016). Approval of BRIVIACT for Partial-Onset Seizures.
4. MarketWatch. (2022). Pharmaceuticals: Industry Analysis and Trends.
5. European Medicines Agency. (2020). Market Authorization for BRIVIACT in the EU.