Brivaracetam - Generic Drug Details

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 five 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:	41
Clinical Trials:	49
Patent Applications:	1,887
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
Muhammad Aamir Latif	NA
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	PHASE1
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.	PHASE1

See all brivaracetam clinical trials

Generic filers with tentative approvals for BRIVARACETAM

Applicant	Application No.	Strength	Dosage Form
		100mg	TABLET; ORAL
		75mg	TABLET; ORAL
		50mg	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214918-003	Dec 20, 2022		DISCN	No	No
Lupin Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214918-004	Dec 20, 2022		DISCN	No	No
Lupin Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214918-002	Dec 20, 2022		DISCN	No	No
Lupin Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214918-001	Dec 20, 2022		DISCN	No	No

Expired US Patents for brivaracetam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016	8,492,416
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016	6,784,197
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016	6,784,197
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016	6,784,197

EU/EMA Drug Approvals for brivaracetam

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 brivaracetam

Country	Patent Number	Title	Estimated Expiration
Iceland	2176
Slovenia	1265862
China	104083328
China	102292071

Supplementary Protection Certificates for brivaracetam

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

Market Dynamics and Financial Trajectory for BRIVARACETAM

Last updated: July 27, 2025

Introduction

Brivaracetam (BRIVARACETAM) is an antiepileptic drug (AED) and a derivative of levetiracetam, developed by UCBPharma. Approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), it has carved a significant niche within the epilepsy treatment paradigm. This analysis explores the current market landscape, key growth drivers, competitive positioning, and the financial trajectory of BRIVARACETAM, providing critical insights for stakeholders and investors.

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Market Landscape and Therapeutic Positioning

Global Epilepsy Market Overview

Epilepsy affects approximately 50 million individuals globally, with a significant proportion requiring long-term pharmacotherapy. The global epilepsy drug market was valued at approximately USD 3.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4-5% through 2030 [1]. This growth is driven by increasing prevalence, rising awareness, and the emergence of new treatment options.

Role of Brivaracetam within AED Portfolio

Brivaracetam is primarily indicated for adjunctive treatment of partial-onset epilepsy (POE) in patients ≥4 years old. Its mechanism involves high affinity for synaptic vesicle protein 2A (SV2A), similar to levetiracetam but with reportedly higher potency and possibly improved tolerability. Its positioning targets patients inadequately controlled on other AEDs, constituting a segment with substantial unmet needs.

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Market Dynamics Influencing Brivaracetam

1. Competitive Landscape

Brivaracetam competes with established AEDs such as levetiracetam, topiramate, lamotrigine, and newer agents like cannabidiol (CBD). Its differentiation relies on efficacy, tolerability, ease of use, and minimal drug-drug interactions.

Levetiracetam remains the most prescribed AED globally, with over 30 million patients treated annually [2]. BRIVARACETAM’s premium positioning as a potentially more tolerable option affords it access to a dedicated patient subset, but price and formulary restrictions influence its market penetration.

Emerging alternatives like cannabidiol (Epidiolex), which has FDA approval for specific epilepsy syndromes, expand treatment options, intensifying competition.

2. Regulatory and Reimbursement Factors

Regulatory approvals in key markets like the U.S., EU, and Japan facilitate market access. However, reimbursement policies significantly impact sales trajectories. Payers demand comprehensive cost-effectiveness data, which can delay or restrict uptake.

3. Geographic Expansion and Market Penetration

While initial launches in North America and select European countries established robust sales channels, expansion into emerging markets like Asia-Pacific remains critical. These markets offer significant growth potential due to rising epilepsy prevalence and increasing healthcare infrastructure.

4. Pricing Dynamics and Healthcare Economics

Pricing strategies for BRIVARACETAM are influenced by competitive pressures, reimbursement negotiations, and patient affordability. As a branded medication, its premium pricing confers higher margins but demands clear differentiation to justify costs over generic options.

5. Market Access and Physician Adoption Trends

Physician prescribing behavior is influenced by clinical guidelines, real-world efficacy, and safety profiles. Increasing awareness and data supporting the benefits of BRIVARACETAM underpin its long-term adoption.

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Financial Trajectory and Revenue Forecasts

Current Revenue Performance

Since its approval in 2016—initially in the U.S. for partial-onset seizures—BRIVARACETAM has demonstrated steady growth, with net sales reaching approximately USD 600 million in 2022 [3]. The product's revenue reflects its established presence in North America and Europe, with modest contributions from emerging markets.

Projected Growth Drivers

• Expanded Indications:
  Ongoing clinical trials investigating BRIVARACETAM for generalized epilepsies could broaden the label, opening new revenue streams.

• Market Penetration Strategies:
  Enhanced physician education, real-world evidence, and formulary inclusion support increased prescribing.

• Pricing and Reimbursement Adjustments:
  Price optimization and better reimbursement coverage enhance profitability.

• Market Expansion Expectations:
  Emerging markets could contribute an incremental USD 100-200 million annually by 2030, contingent on regulatory approvals and healthcare infrastructure development [4].

Forecasted Revenue Trajectory

Based on market conditions and clinical pipeline developments, analysts project that BRIVARACETAM could achieve a compounded annual growth rate of approximately 8-10% through 2030, potentially surpassing USD 1 billion in global sales by then.

Profitability Considerations

While gross margins are high due to patented status, increased competition and pricing pressures might compress margins. The strategic focus on extending indications and geographic expansion will influence overall profitability.

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Market Challenges and Risks

• Generic Competition:
  Patent expirations threaten to introduce lower-cost generics, eroding market share.

• Pipeline Risks:
  Failure in ongoing clinical trials could limit future indications and revenue potential.

• Pricing Pressures:
  Healthcare reforms advocating for lower drug costs might restrict revenue growth.

• Regulatory Delays:
  Additional indications or market approvals may face unforeseen hurdles.

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Strategic Opportunities

• Demonstration of superior safety and efficacy profiles in real-world settings could position BRIVARACETAM as the preferred choice over competitors.

• Developing combination therapies with other AEDs or novel agents offers potential for niche markets.

• Leveraging digital health and monitoring can optimize treatment adherence, improving outcomes and fostering patient loyalty.

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Key Takeaways

• BRIVARACETAM stands as a significant player in the epilepsy pharmacotherapy market, benefiting from ongoing clinical and geographic expansion.

• Market dynamics favor increased adoption due to its favorable tolerability profile, though competition from generics and newer agents remain significant hurdles.

• Revenue prospects remain strong, with forecasts indicating potential sales growth to over USD 1 billion globally by 2030, contingent upon successful pipeline execution and market expansion.

• Price and reimbursement strategies, alongside regulatory pathways, will critically influence its financial trajectory.

• Long-term success hinges on sustained clinical evidence, effective market access initiatives, and strategic diversification.

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FAQs

1. What differentiates Brivaracetam from Levetiracetam?
Brivaracetam exhibits higher affinity for SV2A and potentially fewer side effects, leading to better tolerability. It may also have improved pharmacokinetic properties, enhancing efficacy and adherence.

2. Are there any approved new indications for BRIVARACETAM?
As of 2023, BRIVARACETAM’s primary approval covers partial-onset seizures. Ongoing trials are investigating its efficacy in generalized epilepsies and other neurological disorders, which could expand its label.

3. How does pricing impact BRIVARACETAM’s market share?
As a branded drug, it commands higher prices compared to generics. Reimbursement policies and formulary positioning directly influence its adoption rate and overall market penetration.

4. What is the competitive outlook for BRIVARACETAM in emerging markets?
Growing awareness and infrastructure improvements support market entry. However, price sensitivity and local generic competition limit rapid expansion. Tailored strategies are essential.

5. What are the primary risks to BRIVARACETAM’s financial growth?
Patent expiration, emergence of biosimilars, regulatory delays, and price compression pose significant risks. Additionally, new treatments entering the market could impact growth trajectories.

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References

[1] Market Research Future, “Epilepsy Drugs Market Report,” 2022.
[2] IMS Health Data, “Global AED Prescriptions,” 2021.
[3] UCB Pharma Annual Report, 2022.
[4] Evaluate Pharma, “Top-Line Sales Projections for Brivaracetam,” 2022.