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 six 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:	42
Clinical Trials:	14
Patent Applications:	1,038
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
University of California, Los Angeles	Phase 1/Phase 2
Overseas Pharmaceuticals, Ltd.	Phase 1
GX pharma technology (beijing) Co., Ltd	Phase 1

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	6,911,461		Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016		RX	Yes	No	10,729,653		Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016		RX	Yes	No	6,911,461		Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016		RX	Yes	Yes	6,911,461		Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016		RX	Yes	No	6,911,461		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	6,784,197
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	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	205836-003	May 12, 2016	8,492,416
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016	8,492,416

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/003898 Briviact 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
Serbia	53554	FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE 2-OKSO-1-PIROLIDIN DERIVATE (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES)
Japan	4769756
Malaysia	140593	2-OXO-1-PYRROLIDINE DERIVATIVES, PROCESS FOR PREPARING THEM AND THEIR USES
Norway	20023995
Portugal	1452524

Supplementary Protection Certificates for BRIVIACT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1452524	CR 2016 00013	Denmark		PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
1452524	CA 2016 00013	Denmark		PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
2391349	C20160006 00188	Estonia		PRODUCT NAME: BRIVARATSETAAM;REG NO/DATE: EU/1/15/1073 18.01.2016
1452524	2016/011	Ireland		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	300815	Netherlands		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118

Market Dynamics and Financial Trajectory for BRIVIACT

Introduction

BRIVIACT, also known as brivaracetam, is a key antiepileptic drug developed by UCB S.A., a global biopharmaceutical company. This article delves into the market dynamics and financial trajectory of BRIVIACT, highlighting its performance, market impact, and future prospects.

Market Context of Antiepileptic Drugs

The global antiepileptic drugs (AED) market is projected to grow significantly, with a CAGR of 4.8% from 2024 to 2032, reaching an estimated value of USD 24.85 billion by 2032[1].

BRIVIACT: An Overview

BRIVIACT is an adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy. It has shown promising results in clinical trials, particularly in its efficacy and safety profile.

Clinical Success and Regulatory Approvals

Recent Phase 3 studies in Asia have shown positive top-line results, with BRIVIACT meeting primary and all secondary endpoints. These results are expected to support regulatory submissions in Japan and other regions[4].

Market Performance

BRIVIACT has been a significant contributor to UCB's revenue growth. Despite the overall decline in UCB's revenue in 2023 due to the loss of exclusivity for other products, BRIVIACT has maintained its growth trajectory. The drug is part of UCB's core product portfolio, which has driven the company's net sales[3].

Financial Impact

In 2018, UCB's financial report indicated strong growth driven by its core products, including BRIVIACT. The company's net sales increased by 5% at constant exchange rates, with BRIVIACT contributing to this growth[2].

Revenue Projections

While specific revenue figures for BRIVIACT alone are not always detailed, the drug is expected to continue contributing to UCB's revenue growth. UCB's financial guidance for 2024 forecasts a growing top line, partly due to the performance of BRIVIACT and other growth drivers like EVENITY® and BIMZELX®[5].

Competitive Landscape

The antiepileptic drugs market is dominated by a few key players, including UCB S.A., Pfizer Inc., and GSK plc. BRIVIACT's success has helped UCB maintain its competitive edge, despite challenges such as patent expirations and generic entries. The drug's therapeutic effectiveness and global presence have been crucial in this regard[1].

Regional Market Dynamics

North America, particularly the U.S., has been a strong market for BRIVIACT, driven by higher diagnosis and treatment rates for neurology conditions and favorable reimbursement policies. The drug is also gaining traction in other regions, including Europe and Asia Pacific, where regulatory approvals and increasing awareness are driving demand[1].

Research and Development

UCB has been intensifying its investment in R&D, with a focus on launching innovative and generic products. This strategy is expected to positively impact the global market, including the performance of BRIVIACT. The company's R&D expenses have increased, reflecting its commitment to developing new treatments and maintaining market competitiveness[2][3].

Future Prospects

Given the positive clinical results and ongoing regulatory submissions, BRIVIACT is poised for continued growth. UCB's financial guidance for 2024 and beyond indicates a strong focus on product launches and market expansion, which will likely benefit BRIVIACT. The drug's performance will be a key factor in UCB's ability to deliver growth over the next decade[5].

Challenges and Opportunities

While BRIVIACT faces challenges such as patent expirations and generic competition, UCB's strategic investments in R&D and market expansion are expected to mitigate these risks. The increasing prevalence of epilepsy and growing awareness among patients about new treatment options present significant opportunities for the drug's continued success.

"UCB plans regulatory submissions for Briviact in Japan in Q3 2023... The study efficacy and safety outcomes will support the regulatory submission of brivaracetam in Japan in Q3, 2023."[4]

Key Takeaways

• BRIVIACT is a key antiepileptic drug developed by UCB S.A., showing strong clinical efficacy and safety.
• The drug has contributed significantly to UCB's revenue growth despite overall market challenges.
• Regulatory approvals and positive clinical results are expected to drive BRIVIACT's market expansion.
• UCB's focus on R&D and strategic market investments will support the drug's continued success.
• The global antiepileptic drugs market, particularly in North America, Europe, and Asia Pacific, presents significant growth opportunities for BRIVIACT.

FAQs

Q: What is BRIVIACT used for? A: BRIVIACT (brivaracetam) is used as an adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy.

Q: Who is the manufacturer of BRIVIACT? A: BRIVIACT is manufactured by UCB S.A., a global biopharmaceutical company.

Q: What are the key regions for BRIVIACT's market growth? A: The key regions for BRIVIACT's market growth include North America, Europe, and the Asia Pacific, driven by regulatory approvals, higher diagnosis rates, and favorable reimbursement policies.

Q: How has BRIVIACT performed in clinical trials? A: BRIVIACT has shown positive top-line results in Phase 3 studies, meeting primary and all secondary endpoints, particularly in trials conducted in Asia.

Q: What are the future prospects for BRIVIACT? A: BRIVIACT is expected to continue growing, driven by UCB's strategic investments in R&D, regulatory submissions, and market expansion efforts.

Sources

1. Fortune Business Insights - Antiepileptic Drugs [AED] Market Size, Trends | Forecast, 2032
2. PR Newswire - UCB Full Year Report 2018
3. UCB - UCB on Growth Path for a Decade Plus
4. UCB - UCB announces positive preliminary results for major brivaracetam (Briviact) study in Asia
5. PR Newswire - UCB on Growth Path for a Decade Plus

Last updated: 2024-12-16