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, MSN, Sunshine, and Zydus Pharms, and is included in eight 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.

Six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for brivaracetam

International Patents:	173
US Patents:	2
Tradenames:	2
Applicants:	6
NDAs:	8
Finished Product Suppliers / Packagers:	6
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
Zydus Pharms	BRIVARACETAM	brivaracetam	TABLET;ORAL	214501-001	Oct 3, 2022		DISCN	No	No
Sunshine	BRIVARACETAM	brivaracetam	TABLET;ORAL	214748-002	Jun 9, 2022	AB	RX	No	No
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016	AB	RX	Yes	No	10,729,653		Y
Lupin Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214918-003	Dec 20, 2022		DISCN	No	No
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016	AB	RX	Yes	Yes	6,911,461		Y	Y
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016		RX	Yes	Yes	6,911,461		Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016	AB	RX	Yes	No	10,729,653		Y

Expired US Patents for brivaracetam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016	6,784,197
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016	6,911,461
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016	6,784,197
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016	8,492,416
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016	6,784,197
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016	6,784,197
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016	6,911,461

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
Australia	5214401
South Korea	20050090090
Israel	213545	תכשירי רוקחות המכילים תולדות 2-אוקסו-1-פירולידין (Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives)
European Patent Office	1477478	Derives de 2-oxo-1-pyrrolidine, procédé de préparation et utilisation. (2-oxo-1-pyrrolidine derivatives, process for preparing them and their uses.)
Canada	2401033	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)
Russian Federation	2005125645
European Patent Office	1577295

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
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
1452524	C01452524/01	Switzerland		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016

Brivaracetam: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is the current market landscape for brivaracetam?

Brivaracetam (brand name: Briviact) is an antiepileptic drug (AED) used primarily to treat partial-onset seizures in adults with epilepsy. It was approved by the U.S. Food and Drug Administration (FDA) in 2016 and the European Medicines Agency (EMA) in 2017. Global sales reached approximately $400 million in 2022, with growth driven by expanding indications and geographic penetration.

Major competitors include levetiracetam (market leader), lacosamide, and perampanel. Brivaracetam’s differentiator is its higher affinity for synaptic vesicle protein 2A (SV2A), which improves tolerability and efficacy in certain patient groups.

How have regulatory decisions influenced market entry?

FDA and EMA approvals

• 2016 (FDA): Approved for adjunctive treatment of partial seizures in adults.
• 2017 (EMA): Approved for similar indications across Europe.

Expansions and new indications

• 2018: Post-approval studies on pediatric populations.
• 2020: Filing for monotherapy approval in the U.S. and Europe; approvals pending as of 2023.

Regional authorization status

Region	Approval Status	Notes
North America	Approved (2016)	For adjunctive partial seizures.
Europe	Approved (2017)	For adjunctive partial seizures.
Asia-Pacific	Approved in Japan (2019)	For adjunctive treatment.
Rest of world	Pending approvals or under review	Limited market access in emerging markets.

What are the key market drivers and barriers?

Market Drivers

• Growing epilepsy prevalence: About 50 million globally, increasing demand for effective treatments.
• Expanding indications: Ongoing clinical trials for monotherapy, generalized seizures, and pediatric use.
• Enhanced safety profile: Better tolerability compared to phenobarbital and phenytoin.
• Favorable dosing regimen: Once or twice daily dosing improves patient adherence.

Market Barriers

• High generic penetration: Levetiracetam accounts for over 70% of the epilepsy AED market, constraining growth for branded alternatives.
• Pricing pressures: Payors favor lower-cost generics, limiting revenue growth.
• Limited awareness outside specialist centers: Usage confined to neurologists and epileptologists, slowing adoption.

How does the financial trajectory look?

Revenue evolution

Year	Estimated Global Sales	Growth Rate (YoY)	Key Factors
2016	$20 million	—	Launch year
2018	$180 million	80%	Market expansion, broader insurance coverage
2020	$330 million	83%	Indication expansion, European uptake
2022	$400 million	21%	Saturation in core markets, emerging markets gaining access

R&D expenditure

• Estimated $150 million since 2010, primarily for Phase III trials, registration, and post-marketing studies.
• Ongoing R&D initiatives include clinical trials for monotherapy and other epilepsy types, with projected investments of $50 million over three years.

Market projections

• Compound annual growth rate (CAGR) from 2022 to 2027: approximately 7%
• Forecasted revenue in 2027: $620 million, driven by expanded indications and geographic expansion.

Which factors influence future growth potential?

• Pipeline developments: Ongoing Phase III trials for generalized and pediatric epilepsy. Successful outcomes could unlock new revenue streams.
• Regulatory approvals: Pending approval for monotherapy and broader indications in major markets.
• Pricing negotiations: Managed entry prices in emerging markets could boost volume.
• Market competition: New entrants with novel mechanisms may challenge brivaracetam’s market position.

What are the key risks to financial forecasts?

• Generic erosion: Entry of levetiracetam generics reduces pricing power.
• Regulatory hurdles: Delays or refusals for new indications affect revenue growth.
• Market acceptance: Preference for established therapies may slow growth.
• Manufacturing interruptions: Supply chain disruptions could impact availability.

Summary table of market projections

Year	Estimated Revenue (USD million)	Growth Rate	Drivers/Constraints
2023	$420	5%	Early commercial stability, competition remains tight
2025	$520	6%	Broader indications, emerging markets
2027	$620	7%	Continued pipeline success, increasing adoption

Key Takeaways

• Brivaracetam remains a niche but growing AED with broad potential driven by pipeline progress.
• Competition from levetiracetam and generics constrains pricing, though safety and efficacy advantages support uptake.
• Regulatory milestones, especially regarding monotherapy approval, are pivotal to expanding revenue streams.
• Geographic expansion into emerging markets could significantly influence long-term growth.
• Market risks include regulatory delays, price erosion, and competition from novel treatments.

FAQs

1. What are the main clinical benefits of brivaracetam?
It offers a higher affinity for SV2A, leading to improved tolerability and efficacy in controlling partial seizures over some existing AEDs.

2. How does brivaracetam’s regulatory status impact its market potential?
FDA and EMA approvals enable access in major markets, but pending approvals for monotherapy and broader indications limit revenue at present.

3. What competitive advantages does brivaracetam hold?
A better safety profile, convenient dosing schedules, and clinical data supporting efficacy in difficult-to-treat subpopulations.

4. Which markets are likely to drive the most growth?
North America and Europe remain mature but highly competitive markets. Asia-Pacific, especially Japan and emerging markets, present substantial growth opportunities.

5. How vulnerable is brivaracetam to generic competition?
Highly; levetiracetam's dominance and low-cost generics compress margins. Value differentiation depends on safety, specific indications, and geographic coverage.

---

References

[1] FDA. (2016). FDA approves Briviact to treat partial seizures. U.S. Food and Drug Administration.
[2] EMA. (2017). European Medicines Agency approval of Briviact.
[3] MarketResearch.com. (2023). Global epilepsy market report.
[4] IQVIA. (2022). Top-selling epilepsy drugs.
[5] ClinicalTrials.gov. (2023). Brivaracetam clinical trials.