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. Fifteen 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:	1,148
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	AP	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	AA	RX	Yes	Yes			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016	AB	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	205836-003	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	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	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	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
Australia	2010215646
Brazil	PI1007161
Canada	2747395
China	102292071
China	104083328
Cyprus	1115673
Denmark	2391349

Supplementary Protection Certificates for BRIVIACT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1265862	PA2016013	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	300815	Netherlands		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118
1452524	CA 2016 00013	Denmark		PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
1452524	16C1001	France		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118
1452524	1690009-4	Sweden		PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073 20150114
1265862	PA2016013,C1265862	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	10/2016	Austria		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 (MITTEILUNG) 20160118

BRIVIACT (brivaracetam) Market Dynamics and Financial Trajectory: Revenue Trends, Exclusivity Timeline, Competitive Pressure, and Patent/Generic Risk

Last updated: June 24, 2026

BRIVIACT (brivaracetam) is a branded antiepileptic drug with sustained commercial traction in the US and select international markets, but long-term growth is exposed to loss of exclusivity in multiple geographies, ongoing generic/biosimilar competitive dynamics (where applicable), and payer-driven pressure typical for second-generation antiseizure medicines. The financial trajectory has been shaped more by uptake and formulary position than by a step-change in label scope.

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BRIVIACT revenue growth and market size trends: How has brivaracetam performed commercially?

BRIVIACT commercialization is anchored in its US positioning for focal-onset seizures. The market dynamics have followed the classic antiseizure-drug pattern: initial uptake driven by neurologists and advocacy, followed by payer steering toward lower-cost alternatives and within-class substitutions among levetiracetam derivatives and other newer antiseizure drugs.

What are the main demand drivers for brivaracetam?

• Prescriber switching from levetiracetam due to tolerability and reduced behavioral adverse effects observed clinically for brivaracetam.
• Formulary inclusion at major pharmacy benefit managers (PBMs), often dependent on prior authorization and step therapy.
• Titration and persistence patterns typical for chronic epilepsy therapy, where maintenance on therapy matters more than short-term switching.

What are the main headwinds?

• Within-class competition (other newer antiseizure medicines with similar prescriber adoption trajectories).
• Payer cost-control through preferred-tier placement and contracting for lower WAC or net price equivalents.
• Exclusivity decay across jurisdictions, reducing brand pricing power over time.

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Who sells BRIVIACT and how do partnership or licensing dynamics affect profitability?

BRIVIACT is marketed in the US and multiple geographies through a combination of direct commercialization and regional partner structures typical for mid-to-late phase specialty neurology products.

Key commercial implications

• Net pricing versus list pricing: brivaracetam’s trajectory depends on rebates, contracting structure, and channel mix, not just headline sales.
• Distribution and channel inventory: specialty pharma revenue recognition can shift quarter-to-quarter with wholesaler ordering patterns.
• Lifecycle management: trade-down strategies and generic entry preparation by the brand holder impact realized margins.

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What is BRIVIACT’s exclusivity timeline and when does brivaracetam lose market exclusivity?

Exclusivity and patent term control the pace of generic erosion. For antiseizure drugs, generic entry risk increases as secondary formulation and method-of-use patents expire, and as regulatory exclusivities (where relevant) run out.

How exclusivity typically layers for BRIVIACT

• Composition-of-matter patents: protect the active ingredient.
• Formulation patents: protect specific dose forms, release profiles, or manufacturing details.
• Method-of-use patents: protect therapeutic dosing regimens or specific patient subgroups.
• Regulatory exclusivities: US market exclusivity can delay generic filing/approval even if patents expire, depending on application history and exclusivity grants.

Exclusivity decay effect on financial trajectory

Once exclusivity weakens, the brand’s revenue usually experiences:

• Net price compression in the first 6 to 18 months after generic entry.
• Reduced share as payers shift to contracted generics and biosimilar-like price competition mechanisms (even though brivaracetam is small molecule, the contracting behavior is similar).
• Margin erosion that may lead to brand-level cost reductions and marketing budget changes.

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What patents protect BRIVIACT (brivaracetam) in the US and key international markets?

BRIVIACT’s patent estate typically includes:

• API composition claims covering brivaracetam and closely related chemical variants.
• Solid-state and formulation claims tied to tablet/capsule compositions and manufacturing methods.
• Use claims covering epilepsy treatment.

How to evaluate BRIVIACT patent coverage for risk modeling

Patent estates for branded antiseizure drugs usually fail in the market in stages:

1. First wave: composition-of-matter expiry.
2. Second wave: formulation patent expiry and generic product design-around or paragraph IV certifications.
3. Third wave: method-of-use and residual process patents.

This staged decay is what typically produces a multi-year revenue slope rather than a single breakpoint.

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How strong is the patent estate for brivaracetam: what litigation and validity challenges matter?

Patent strength is reflected in whether challengers file paragraph IV certifications, whether cases settle, and whether courts uphold key claims.

What matters most for business outcomes

• Suit timing: earliest filing dates set the expected generic launch window.
• Claim scope: broad method-of-use claims can block design-around.
• Injunction leverage: settlements often include license terms with delayed launch.

What financial outcomes follow patent litigation

• Settlements that delay entry can preserve revenue for the settlement period.
• Loss of key claims can accelerate generic erosion and trigger steeper revenue declines.

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What is the Orange Book status of BRIVIACT (brivaracetam) and how many patents are listed?

The Orange Book listing count and patent categories are the most direct way to map regulatory entry risk for generics. For risk modeling, focus on:

• Drug substance patents (composition)
• Drug product patents (formulation)
• Method-of-use patents

How Orange Book structure affects generic strategy

• If Orange Book lists only a few patents tied to the drug substance, challengers can target product-design arounds sooner.
• If product and method-of-use patents dominate, generic entry is delayed or becomes more complex.

(A complete enumeration of Orange Book-listed BRIVIACT patents and their expiration dates requires specific Orange Book records by NDA and strength; without that record set, the patent count cannot be stated accurately.)

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What generic entry risks exist for BRIVIACT: will generics launch immediately after patents expire?

Generic entry is influenced by:

• Paragraph IV filing behavior (who filed, when, and what claims were challenged).
• Carve-outs and settlements that permit earlier or delayed launches.
• Availability of approved generics tied to manufacturing readiness.

Common launch dynamics in the US

• First generic often captures meaningful share quickly if contracting is favorable.
• Subsequent generics push net prices lower and can reduce brand share further.
• Auto-substitution and formulary revisions can increase switching after initial generic uptake.

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How does BRIVIACT compare with levetiracetam and other newer antiseizure drugs in market share pressure?

Brivaracetam competes with:

• Levetiracetam (including extended-release products and multiple generics)
• Other newer antiseizure medicines that gained share through tolerability, dosing, and evidence profiles.

What typically drives relative adoption

• Tolerability and psychiatric side effect profile relative to levetiracetam.
• Dosing convenience and clinician familiarity.
• Evidence base in focal-onset seizures.

What typically drives displacement over time

• Net price and payer contracting against brands
• Generic availability of the competitive baseline (especially levetiracetam, which is widely generic in many markets)

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What formulations are protected by BRIVIACT patents: tablets, dosing strengths, and manufacturing methods?

Antiseizure products often have a layered protection stack:

• API solid form and crystalline state claims
• Tableting and excipient composition claims
• Release and stability claims (where applicable)

Business impact of formulation patents

Formulation patents can:

• Delay generic approval if challengers cannot certify “not infringement” for key product features.
• Force design-around that increases manufacturing complexity and time-to-market.

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What method-of-use patents exist for brivaracetam and how do they affect generic approval?

Method-of-use protection can block generics if:

• Orange Book includes use claims tied to specific dosing regimens, patient populations, or therapeutic endpoints.
• Generics must either omit the infringing use from labeling or face infringement litigation.

Business impact

Method-of-use claims often drive:

• Label carve-outs and shared risk settlements.
• Longer exclusivity “tails” after composition patents expire.

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What FDA regulatory status does BRIVIACT have and how does it affect generics?

BRIVIACT is a US-approved small-molecule antiseizure drug. The FDA regulatory status influences:

• Generic pathway eligibility through ANDA
• The ability to file or approve based on exclusivity (patents and regulatory exclusivities)

Generics and regulatory exclusivity

Even if patents weaken, regulatory exclusivity can delay approval timelines depending on application history. Patent expiration and exclusivity grant are the two clocks that determine commercial impact.

(A specific FDA timeline and exclusivity grants for brivaracetam require NDA/ANDA identification and FDA exclusivity tables; those are not provided here.)

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How do settlement agreements in BRIVIACT patent litigation influence launch timing and sales?

Patent settlements in branded epilepsy typically do one of the following:

• Permit a generic launch on a defined date with limited design/label features.
• Provide a brand-payment or cross-license with a delayed entry window.
• Resolve remaining infringement claims and define the approved labeling.

Sales effect

• Delayed generic launch keeps net price support longer.
• Partial design/label changes can slow switching and preserve brand share relative to a full-launch scenario.

(Specific BRIVIACT settlement terms cannot be listed without citation to the relevant docket outcomes.)

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Where is BRIVIACT at highest revenue exposure: which regions matter most?

Commercial exposure concentrates in:

• United States, because of payer concentration and generic entry economics.
• European core markets, where pricing pressure is strong and formularies are managed tightly.
• Japan and select APAC markets, where approvals and patent stacks can delay erosion relative to US timing.

International differences that change trajectory

• Patent term adjustments and patent linkage frameworks
• National reimbursement and tender systems
• Local generic launch behavior and price elasticity

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Key timeline for BRIVIACT exclusivity, generic risk, and likely revenue slope

Because brivaracetam has multiple layers of protection, the market shape is usually:

• Stable brand share during composition patent coverage
• Gradual price compression as product/formulation patents narrow
• Step-down around first generic approvals, then slower erosion as additional competitors enter

(A date-specific timeline with patent numbers and expiration dates requires Orange Book and patent-register extraction by NDA and strength.)

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Key Takeaways

• BRIVIACT’s long-term financial trajectory is governed by a layered IP stack: composition, formulation, and method-of-use, plus any regulatory exclusivities.
• Revenue resilience in epilepsy brands typically persists until generic approvals begin, after which net price and market share decline accelerate.
• The biggest business risks are driven by US and major-market patent expiration sequencing and by paragraph IV litigation/settlement outcomes that define launch timing.
• Competitive pressure is structural: within-class substitution and payer contracting against lower-cost antiseizure alternatives generally increase over time, even without immediate generic entry.

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FAQs

1) What drives BRIVIACT price erosion when generics enter?

Payer contracting, rebate renegotiation, and formulary switching toward the lowest net-price products drive the initial net price compression.

2) How do BRIVIACT formulation patents influence generic label design?

Generics may seek design-around changes or labeling carve-outs if product/formulation features are tied to Orange Book drug product patents.

3) Can brivaracetam face method-of-use blocking even after composition patents expire?

Yes, if method-of-use claims are listed in the Orange Book and challengers cannot certify non-infringement for those uses.

4) What matters more for brand share: efficacy, tolerability, or payer policy?

Over multiple years, payer policy and net pricing often dominate once therapeutic differentiation narrows and multiple antiseizure alternatives are available.

5) What commercial impact do patent settlements usually have on first generic launch timing?

Settlements commonly shift launch dates to a defined window and can preserve brand revenue longer than a strict expiration-only model.

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References

(No sources were cited because no NDA-specific Orange Book, FDA approval/exclusivity, patent register, or litigation docket details were provided in the prompt.)

DrugChatter Q&A for BRIVIACT

Is there a generic form of briviact?
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Seizure medication briviact?
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When is briviact going generic?