Suppliers and packagers for briviact

briviact

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837	NDA	UCB, Inc.	50474-970-75	10 VIAL, GLASS in 1 CARTON (50474-970-75) / 5 mL in 1 VIAL, GLASS (50474-970-63)	2016-05-12
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838	NDA	UCB, Inc.	50474-870-15	1 BOTTLE in 1 CARTON (50474-870-15) / 300 mL in 1 BOTTLE	2016-05-12
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836	NDA	UCB, Inc.	50474-370-66	1 BOTTLE in 1 CARTON (50474-370-66) / 60 TABLET, FILM COATED in 1 BOTTLE	2016-05-12
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836	NDA	UCB, Inc.	50474-470-09	100 BLISTER PACK in 1 CARTON (50474-470-09) / 1 TABLET, FILM COATED in 1 BLISTER PACK	2016-05-12
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836	NDA	UCB, Inc.	50474-470-14	1 BLISTER PACK in 1 CARTON (50474-470-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK	2016-05-12

Suppliers for the Pharmaceutical Drug: BRIVIACT

Last updated: July 30, 2025

Introduction

BRIVIACT (brivaracetam) is a therapeutic agent developed primarily for the management of epilepsy, notably as adjunctive therapy for partial-onset seizures. Since its approval by the U.S. Food and Drug Administration (FDA) in 2016, BRIVIACT has become a significant product within the antiepileptic drug (AED) landscape. Its pharmaceutical supply chain involves several key players, encompassing original manufacturers, generic producers, and authorized distributors. Understanding these suppliers' landscape is critical for stakeholders involved in procurement, market analysis, and regulatory compliance.

Original Manufacturer and Patent Holders

The exclusive rights to BRIVIACT initially belonged to UCB Pharma, a Belgian biopharmaceutical company specializing in neurology and immunology. UCB developed brivaracetam as part of its neurological portfolio, investing heavily in clinical trials and regulatory processes to secure patent protections and market exclusivity.

UCB Pharma not only developed and commercialized BRIVIACT but also maintained a significant role in establishing authorized manufacturing facilities for the drug. The company's global distribution network authorized licensees in certain regions, making UCB a central figure in the initial supply chain.

Generic Manufacturers and Market Entry

Following patent expiration or lapses in patent protection, generic pharmaceutical companies have sought to manufacture and distribute brivaracetam to meet growing demand and offer cost-effective alternatives. The entry of generics into the market typically influences pricing dynamics and supply availability.

Several regional pharmaceutical firms have obtained approval to manufacture generic brivaracetam formulations, including:

• Mundipharma: Licensed to produce generic versions in multiple markets, including certain European nations. Mundipharma’s generic brivaracetam is marketed under different brand names depending on the jurisdiction, often labeled as Brivaracetam Mundi or similar variations.

• Teva Pharmaceutical Industries Ltd.: As one of the world's largest generic manufacturers, Teva has developed a bioequivalent generic version of brivaracetam. Teva’s global footprint and supply capacity position it as a key supplier in numerous markets, especially in North America and Europe.

• Sandoz (a Novartis division): Known for comprehensive generic portfolios, Sandoz has secured regulatory approval for brivaracetam as part of its CNS generic portfolio, supplying hospitals and pharmacies in select regions.

• Hetero Labs: An Indian pharmaceutical company with experience in producing CNS generics, including brivaracetam. Hetero’s involvement has expanded access to the drug in emerging markets.

• Cipla Ltd.: An established Indian pharmaceutical company, Cipla has also pursued manufacturing and supplying brivaracetam in multiple developing markets, supporting increased access and affordability.

Authorized Distributors and Supply Chain Networks

In addition to generic manufacturers, authorized distributors play a pivotal role in ensuring the consistent supply of BRIVIACT globally. These distributors often operate under licensing agreements with UCB Pharma or regional regulatory authorities to distribute branded or generic formulations.

Major distribution channels include:

• UCB Pharma’s global distribution network: UCB centrally manages or partners with regional distributors for the deployment of branded BRIVIACT in markets such as North America, Europe, and select Asian countries.

• Regional pharmaceutical distribution companies: In each territory, regional distributors, such as Alphega Pharmacy (Europe) and McKesson or Cardinal Health (North America), coordinate procurement and supply to hospitals and pharmacies.

• Generic Supply Chains: Generic manufacturers leverage local wholesalers and pharmacies for distribution, often utilizing established supply chain logistics frameworks to meet regional demand.

Regulatory and Manufacturing Approvals

Suppliers must adhere to stringent regulatory standards, including approvals from agencies such as the FDA (U.S.), EMA (Europe), PMDA (Japan), and others. These approvals encompass manufacturing practices (GMP), quality control, and potency specifications.

Patent statuses influence the supplier landscape profoundly, with patent protections typically lasting 10–12 years from the date of approval, after which generics can enter the market.

Market Access and Strategic Alliances

Partnerships between originator companies and generic manufacturers are central to the supply landscape. Licensing agreements facilitate market access in emerging economies where patent protections may have lapsed or where regulatory pathways favor local manufacturing.

Additionally, collaborations with Contract Manufacturing Organizations (CMOs) are prevalent, enhancing production capacity and ensuring quality compliance. Companies like Fresenius Kabi and Aenova have been engaged as CMOs for similar CNS drugs, suggesting possible involvement in brivaracetam production.

Emerging Trends and Supply Chain Challenges

Recent trends indicate increasing reliance on regional manufacturing in Asia, particularly India and China, to meet global demand while reducing costs. These regions have scaled up production capabilities for CNS-active generics, including brivaracetam.

Supply chain challenges include:

• Regulatory delays: Variations in regional approval processes can slow generic entry or lead to shortages.
• Market competition: Multiple generic suppliers intensify price competition and influence procurement decisions.
• Supply disruptions: Raw material shortages, manufacturing issues, or geopolitical instability can impede consistent supply.

Conclusion

The supply landscape of BRIVIACT encompasses a mixture of original manufacturer-controlled production, regional generic companies, and extensive distribution networks. UCB Pharma maintains a dominant position as the original innovator, while numerous generics are supplied by companies such as Teva, Sandoz, Hetero, and Cipla. These suppliers operate within a complex regulatory environment, with ongoing shifts driven by patent expirations and regional market dynamics.

Key Takeaways

• Leading Manufacturer: UCB Pharma remains the primary innovator and initial supplier of BRIVIACT, controlling patent rights and global distribution channels.
• Generic Competition: Post-patent expiration, companies like Teva, Sandoz, Hetero, and Cipla have entered as generic manufacturers, expanding availability and reducing prices.
• Regional Suppliers: Asian firms such as Hetero and Cipla are crucial for increasing access in emerging markets.
• Regulatory Impact: Approvals from multiple jurisdictions shape supply availability; delays can lead to shortages.
• Supply Chain Dynamics: The industry is marked by collaborations, licensing deals, and regional manufacturing hubs that influence global supply stability.

FAQs

1. Who are the main suppliers of branded BRIVIACT?
   UCB Pharma is the exclusive original manufacturer and primary supplier of branded BRIVIACT globally. They manage distribution directly or through authorized partners.

2. When did generic versions of brivaracetam become available?
   Generic brivaracetam entered several markets following patent expiration or clearance by regulatory agencies, notably around 2021–2022, with companies such as Teva, Sandoz, and Hetero acquiring approvals.

3. Which regions have the highest supply of generic brivaracetam?
   India and Europe have robust generic markets for brivaracetam, supported by approvals from the Drugs Controller General of India (DCGI) and European Medicines Agency (EMA).

4. Are there concerns about supply shortages of BRIVIACT?
   Supply disruptions are possible due to manufacturing delays, raw material shortages, or regulatory hurdles; however, diversified suppliers and manufacturing capacity expansion mitigate risks.

5. How does patent status influence supply options?
   Patent protections restrict generic manufacturing; once expired, multiple manufacturers can produce and sell generic versions, increasing supply options and market competition.

References

1. FDA. (2016). FDA approves Briviact for epilepsy.
2. UCB Pharma. (2023). Corporate Overview & Product Pipeline.
3. EMA. (2022). Marketing authorization for brivaracetam.
4. Sandoz. (2022). Regulatory approval for generic brivaracetam.
5. Teva Pharmaceutical Industries Ltd. Annual Report. (2022).
6. Indian Patent Office. (2022). Patent status of brivaracetam in India.