BRIVARACETAM - Generic Drug Details

What are the generic sources for brivaracetam and what is the scope of patent protection?

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 six 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:	43
Clinical Trials:	44
Patent Applications:	1,398
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
University of California, Los Angeles	Phase 1/Phase 2
University of Minnesota	Phase 3
GX pharma technology (beijing) Co., Ltd	Phase 1

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
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016		RX	Yes	No	6,911,461		Y	Y
Zydus Pharms	BRIVARACETAM	brivaracetam	TABLET;ORAL	214501-004	Oct 3, 2022		DISCN	No	No
Zydus Pharms	BRIVARACETAM	brivaracetam	TABLET;ORAL	214501-001	Oct 3, 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	SOLUTION;ORAL	205838-001	May 12, 2016	6,784,197
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016	8,492,416
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016	8,492,416
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	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/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 BRIVARACETAM

Country	Patent Number	Title	Estimated Expiration
Japan	4938259
Hungary	0300196
Bulgaria	107004
Czech Republic	304420	2-Oxo-1-pyrrolidinové deriváty, způsob jejich přípravy a jejich použití (2-Oxo-1-pyrrolidine derivatives, process of their preparation and their use)

Supplementary Protection Certificates for BRIVARACETAM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1452524	530	Finland
1452524	16C1001	France		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118
1452524	2016/011	Ireland		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	CR 2016 00013	Denmark		PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118

BRIVARACETAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Brivaracetam

Introduction

Brivaracetam, a medication used primarily for the treatment of partial-onset seizures, has been a significant player in the pharmaceutical market, particularly in the realm of antiepileptic drugs. This article delves into the market dynamics and financial trajectory of brivaracetam, highlighting its current status, growth prospects, and the factors influencing its market performance.

Market Overview

Brivaracetam is marketed under the brand name BRIVIACT® by UCB, a global biopharmaceutical company. The drug has been approved for use in various regions, including the U.S., Europe, and Japan, for the treatment of partial-onset seizures in patients with epilepsy[2][3].

Market Size and Growth Projections

The global Brivaracetam API market is expected to experience substantial growth from 2023 to 2031. This growth is driven by increasing demand for effective antiepileptic medications and the expanding patient population. The market is segmented based on type (Type I, Type II, Type III, Type IV) and application (Tablet, Injection, Others), with geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa contributing to the overall market size[1].

Financial Performance of UCB

UCB's financial reports provide insight into the performance of BRIVIACT®. In the first six months of 2022, UCB's revenue increased by 5% to €2.925 billion, with net sales of BRIVIACT® contributing to this growth. Despite generic erosion affecting other products like VIMPAT® and E KEPPRA®, BRIVIACT® continued to show strong growth[2].

In 2023, UCB's revenue reached €5.25 billion, with BRIVIACT® among the products driving this growth. The net sales of BRIVIACT® showed double-digit growth, contributing significantly to UCB's overall revenue[3].

Key Drivers and Restraints

Drivers

• Increasing Patient Population: The growing number of patients with epilepsy who do not achieve adequate seizure control with existing medications drives the demand for brivaracetam.
• Clinical Efficacy: Brivaracetam's effectiveness in reducing seizure frequency and its favorable safety profile make it an attractive option for both patients and healthcare providers[4].
• Market Expansion: UCB's strategic efforts to expand the availability of BRIVIACT® in new markets and regions contribute to its growing revenue.

Restraints

• Generic Erosion: The loss of exclusivity for other UCB products, such as VIMPAT® and E KEPPRA®, can impact overall revenue, although BRIVIACT® has been less affected by this trend[2][3].
• Competition: The antiepileptic drug market is competitive, with several other medications available. However, brivaracetam's unique mechanism of action and clinical benefits help it maintain a strong market position.

Budget Impact and Cost-Effectiveness

A budget impact analysis conducted in the Valencia Community, Spain, indicated that the introduction of brivaracetam as an adjunctive therapy for partial-onset epilepsy could lead to savings for the health system. The study estimated that the annual expenditure on antiepileptics would decrease by 0.09-0.37%, representing €41,873 over a five-year period. This is due to the predictable and fixed annual cost of brivaracetam, which does not require titration[4].

Market Dynamics

Market Segmentation

The Brivaracetam API market is segmented based on type and application. The tablet form is a significant segment, given its ease of administration and patient compliance. Geographical segmentation reveals that North America and Europe are key markets, with Asia-Pacific showing promising growth potential[1].

Competitive Landscape

UCB's strong portfolio, including BRIVIACT®, CIMZIA®, FINTEPLA®, and BIMZELX®, positions the company favorably in the market. However, competition from other pharmaceutical companies and generic alternatives remains a challenge[2][3].

Regulatory Environment

Regulatory approvals and compliance are crucial for the market dynamics of brivaracetam. UCB has successfully navigated regulatory hurdles, securing approvals for BRIVIACT® in various regions. Ongoing clinical trials and new indications also contribute to the drug's market trajectory[3].

Future Outlook

Growth Prospects

UCB's financial guidance for 2024 indicates continued growth, with revenue expected to reach €5.5-5.7 billion. The strong performance of BRIVIACT®, along with other growth drivers like FINTEPLA® and BIMZELX®, is expected to drive this growth[3].

Clinical Pipeline

UCB's robust clinical pipeline, including new indications and potential medicines for various patient populations, ensures a promising future for BRIVIACT®. The company's commitment to innovation and patient access is likely to sustain the drug's market position[3].

Key Takeaways

• Strong Market Growth: The Brivaracetam API market is projected to grow significantly from 2023 to 2031.
• Financial Performance: UCB's revenue and net sales have been positively impacted by the strong growth of BRIVIACT®.
• Cost-Effectiveness: Brivaracetam offers predictable and fixed annual costs, leading to potential savings for health systems.
• Competitive Advantage: BRIVIACT®'s unique clinical benefits and UCB's strategic market expansion efforts maintain its competitive edge.
• Future Outlook: Continued growth is expected, driven by UCB's strong product portfolio and robust clinical pipeline.

FAQs

Q: What is the primary use of brivaracetam? A: Brivaracetam is primarily used as an adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy.

Q: Which company markets brivaracetam? A: Brivaracetam is marketed by UCB under the brand name BRIVIACT®.

Q: What are the key drivers of the brivaracetam market? A: The increasing patient population, clinical efficacy, and market expansion are key drivers of the brivaracetam market.

Q: How does brivaracetam impact healthcare budgets? A: Brivaracetam can lead to savings for health systems due to its predictable and fixed annual cost, as it does not require titration.

Q: What is the future outlook for the brivaracetam market? A: The market is expected to grow significantly, driven by UCB's strong product portfolio and robust clinical pipeline.

Sources

1. Market Research Intellect: Global Brivaracetam API Market Size, Scope And Forecast Report.
2. UCB: Strong first six months – UCB with continued delivery and strong resilience.
3. UCB: UCB on Growth Path for a Decade Plus.
4. PubMed: Budget Impact Analysis of Brivaracetam Adjunctive Therapy for Partial-Onset Seizures.