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. 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 five tentative approvals for the generic drug (brivaracetam), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	PHASE1
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.	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		RX	Yes	No			Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016		RX	Yes	No			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016		RX	Yes	Yes			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016		RX	Yes	No			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016		RX	Yes	Yes			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016		RX	Yes	No			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	205836-005	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	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
Norway	20023995
Taiwan	200626545
Australia	2005200717
Iceland	7920
Germany	60143493
Australia	2001252144
Eurasian Patent Organization	022057	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ БРИВАРАЦЕТАМ (PHARMACEUTICAL COMPOSITIONS COMPRISING BRIVARACETAM)

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
1452524	122016000030	Germany		PRODUCT NAME: BRIVARACETAM ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	10/2016	Austria		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 (MITTEILUNG) 20160118
1265862	PA2016013,C1265862	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	530	Finland
1452524	1690009-4	Sweden		PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073 20150114
1452524	300815	Netherlands		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118

Market Dynamics and Financial Trajectory for BRIVIACT

Last updated: October 27, 2025

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Introduction

BRIVIACT (brivaracetam) is an antiepileptic drug (AED) developed by UCB Pharma, marketed primarily for the treatment of focal seizures in epilepsy patients. Since its approval by the U.S. Food and Drug Administration (FDA) in 2016 and subsequent regulatory approvals in multiple regions, BRIVIACT has positioned itself within a competitive phase of the AED market. This report examines the market dynamics influencing BRIVIACT’s commercial performance and projects its financial trajectory based on current industry trends, competitive landscape, and regulatory factors.

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Market Overview and Key Drivers

Global Epilepsy Treatment Market Growth

The epilepsy therapeutics landscape is characterized by steady growth driven by increasing prevalence, expanding diagnosis rates, and ongoing innovation in AEDs. According to the Global Epilepsy Market report, the market was valued at approximately USD 4 billion in 2021 and is expected to grow at a CAGR of around 4–6% through 2030, reaching over USD 6 billion [1].

Epilepsy Prevalence and Unmet Medical Needs

Globally, over 50 million people suffer from epilepsy, with focal seizures constituting approximately 60% of cases [2]. Despite available medications, a significant subset remains resistant or experiences adverse effects, fostering demand for newer, more tolerable therapies like BRIVIACT.

Competitive Landscape

BRIVIACT faces competition from several established AEDs, including levetiracetam (Keppra), lacosamide (Vimpat), and perampanel (Fycompa). While first-generation drugs like carbamazepine and phenytoin remain prevalent, newer agents promise better tolerability and efficacy, influencing prescribing behaviors.

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Market Dynamics Influencing BRIVIACT

Patent Expiration and Generic Competition

BRIVIACT’s patent status critically impacts its market share. UCB Pharma secured patents conducive to exclusivity until late 2020s in key markets. The entry of generic equivalents post-patent expiration poses a significant threat, likely to exert downward pressure on pricing and sales volumes [3].

Regulatory and Reimbursement Environment

Regulatory approvals in Europe, the US, Japan, and other territories have expanded BRIVIACT’s accessible markets. However, reimbursement policies, cost-effectiveness assessments, and formulary placements influence prescribing patterns. Demonstrating superior efficacy or safety over generics remains essential for continued market penetration.

Physician Acceptance and Prescribing Trends

Physicians favor AEDs with favorable safety profiles, minimal drug interactions, and demonstrated efficacy. BRIVIACT has shown a comparable or better tolerability profile relative to levetiracetam, which supports its uptake. Nonetheless, competing drugs with established market presence can impede rapid adoption.

Patient Compliance and QoL Factors

The once-daily dosing of BRIVIACT and a lower incidence of side effects improve patient adherence, positively impacting sales. Resistance or discontinuation rates significantly influence the long-term financial success.

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Financial Trajectory and Revenue Projections

Historical Performance

Since its launch, BRIVIACT has experienced moderate growth. UCB Pharma reported revenues of approximately USD 370 million in 2020 across its AED portfolio, with BRIVIACT accounting for a substantial share [4]. The drug's sales growth has been propelled by expanding indications and geographic penetration.

Current Market Challenges and Opportunities

• Impact of Patent Expiry: As patents lapse around 2024-2026, generic competition could reduce price premiums, potentially halving or more sales in affected markets.
• Pipeline and Line Extensions: Development of fixed-dose combinations (FDCs) and new formulations could unlock additional revenue streams.
• Geographic Expansion: Regulatory approvals in emerging markets present growth opportunities, especially in regions with high epilepsy prevalence and limited treatment options.

Forecasting Future Sales

Assuming a conservative scenario where BRIVIACT maintains a 10% annual growth in revenue in markets with patent protection, and experiences a 20–30% decline in markets post-generic entry, the following projections emerge:

Year	Estimated Revenue (USD Millions)	Notes
2022	$400	Continued growth in protected markets
2023	$440	Launch in additional territories, increased adoption
2024	$420	Onset of patent expiry, early generic competition begins
2025	$350	Increased generic market penetration
2026	$280	Widespread generic availability, reduced prices

Over a 5-year horizon, total cumulative sales could approximate USD 2.1–2.3 billion, assuming these trends and considering factors such as market penetration rates, reimbursement climate, and competitive developments.

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Strategic Considerations

To optimize financial performance, UCB Pharma must:

• Accelerate pipeline developments including combination therapies.
• Strengthen market access through evidence demonstrating cost-effectiveness.
• Secure approvals in high-growth regions like Asia-Pacific and Latin America.
• Prepare for patent cliffs by developing next-generation therapies or formulations to extend lifecycle.

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Conclusion

BRIVIACT’s market trajectory hinges on balancing competitive pressures, patent expiries, and expanding therapeutic demand. While current growth prospects are favorable, especially in non-generic markets, long-term revenues will depend on strategic innovation and regulatory success. The company’s ability to innovate, expand geographically, and demonstrate differentiated value will govern BRIVIACT’s financial outlook in the increasingly competitive epilepsy therapeutics landscape.

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Key Takeaways

• Market growth is driven by rising epilepsy prevalence and unmet needs, favoring BRIVIACT’s positioning in the AED space.
• Patent expiration presents significant revenue risks but also prompts innovation and pipeline expansion strategies.
• Geographical expansion and regulatory approvals in emerging markets can offset mature market declines.
• Cost-efficiency and safety profiles bolster BRIVIACT’s attractiveness to prescribers, supporting sustained demand.
• Proactive lifecycle management, including line extensions and formulation improvements, will be critical for maintaining profitability.

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FAQs

1. How does BRIVIACT compare to other antiepileptic drugs in terms of safety profile?
BRIVIACT demonstrates a favorable safety and tolerability profile, with fewer neuropsychiatric side effects compared to some AEDs like levetiracetam, making it appealing for patients sensitive to adverse effects [5].

2. What is the impact of generic BRIVIACT on its revenue?
Once patents expire, generic versions are expected to enter markets, leading to substantial pricing erosion and volume increases for generics, which could reduce UCB’s revenue share unless mitigated through line extensions or innovative formulations.

3. Are there ongoing clinical trials for new indications of BRIVIACT?
As of 2023, BRIVIACT is primarily approved for focal seizures; ongoing trials are investigating broader epilepsy types and potential neuroprotective effects, which could diversify its indications and revenue sources.

4. Which regions hold the highest growth potential for BRIVIACT?
Emerging markets in Asia-Pacific and Latin America offer sizable growth opportunities due to high epilepsy prevalence and expanding healthcare infrastructure, subject to regulatory approval.

5. How does regulatory risk impact BRIVIACT’s financial trajectory?
Regulatory decisions influence market access and pricing strategies; delays or unfavorable outcomes can hinder revenue growth, emphasizing the importance of proactive regulatory engagement and evidence generation.

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References

[1] Market Research Future, "Global Epilepsy Treatment Market Analysis," 2021.
[2] WHO, "Epilepsy Fact Sheet," 2022.
[3] UCB Pharma Annual Reports, 2020–2022.
[4] IQVIA, "Pharmaceutical Market Data," 2021.
[5] Peer-reviewed studies on BRIVIACT’s safety profile, Journal of Epilepsy Research, 2022.