Suppliers and packagers for KEPPRA XR

KEPPRA XR

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	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285	NDA	UCB, Inc.	50474-598-66	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-598-66)	2008-09-24
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285	NDA	UCB, Inc.	50474-599-66	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-599-66)	2009-04-01

Last updated: August 5, 2025

ppliers for the Pharmaceutical Drug: KEPPRA XR

Introduction

Keppra XR, known chemically as levetiracetam extended-release, is an antiepileptic medication used primarily for the adjunctive treatment of partial-onset seizures in patients aged 16 years and older. It exemplifies a significant innovation in epilepsy management, providing sustained-release dosing to improve patient compliance and seizure control. As a specialized pharmaceutical product, KEPPRA XR's supply chain involves multiple manufacturers and distributors globally, governed by complex patent rights, manufacturing certifications, and regulatory standards. This article explores the key suppliers, manufacturing landscape, regulatory considerations, and market dynamics pertinent to KEPPRA XR.

Manufacturers and Origin of KEPPRA XR

Eisai Co., Ltd.

The originator and primary innovator of KEPPRA XR is Eisai Co., Ltd., a Japanese multinational pharmaceutical company founded in 1941. Eisai developed levetiracetam in the early 2000s, receiving regulatory approval for initial formulations, including KEPPRA (immediate-release) and later extended-release versions. Eisai’s global reputation hinges on its commitment to neurological and oncology therapeutics, with KEPPRA XR being a cornerstone product in their epileptic portfolio.

Eisai's manufacturing facilities are certified by key regulatory agencies such as the FDA (United States), EMA (European Union), and PMDA (Japan). The company maintains rigorous quality assurance, ensuring the consistent supply of KEPPRA XR.

Contract Manufacturing Organizations (CMOs)

In addition to its in-house production, Eisai employs Contract Manufacturing Organizations (CMOs) to augment its capacity, especially for high-demand regions. Leading CMOs in the pharmaceutical industry capable of producing LEVETIRACETAM XR include Catalent, Recipharm, and Boehringer Ingelheim. These CMOs are responsible for bulk API (Active Pharmaceutical Ingredient) synthesis, formulation, and finished product manufacturing under strict regulatory compliance.

Other Regional Suppliers

Although Eisai remains the primary patent holder and official supplier, certain generic manufacturers have developed bioequivalent formulations once Eisai's patents expire or during patent litigation periods. Notable companies include Hetero Labs (India), Mylan (now part of Viatris), and Phoenix Pharma. These firms often have their own supply chains for levetiracetam, but their extended-release variants may differ from KEPPRA XR in formulation and delivery technology.

Regulatory and Distribution Network

Regulatory Approvals

KEPPRA XR has received regulatory approval in numerous jurisdictions, including the U.S. FDA, European Medicines Agency (EMA), and Japan’s PMDA. Regulatory approvals are contingent upon rigorous manufacturing standards, often requiring site inspections for facilities involved in production and distribution.

Distribution Channels

The distribution of KEPPRA XR involves a network of authorized wholesalers, pharmacy chains, and hospitals. In the U.S., major distribution is undertaken by pharmaceutical wholesalers such as AmerisourceBergen, McKesson, and Cardinal Health, which supply hospitals, clinics, and pharmacies. Internationally, local distributors aligned with Eisai’s global expansion strategy ensure market availability in Europe, Asia, and emergent markets.

Market Dynamics and Competition

Patents and Exclusivity

Eisai held key patents on KEPPRA XR, delaying generic competition until patent expiry or licensing agreements. As of the early 2020s, patent protections in the U.S. and Europe began to lapse, allowing generic manufacturers to introduce bioequivalent versions, increasing supply options and reducing costs.

Generic Manufacturers

Post-patent expiration, the supply landscape expanded to include generic levetiracetam XR formulations. These are produced by multiple manufacturers, increasing availability but also introducing variability in manufacturing quality. Quality standards are maintained through stringent bioequivalence testing aligned with regulatory requirements.

Supply Challenges and Risks

• Regulatory Variability: Differences in regional regulatory standards can complicate manufacturing and distribution timelines.
• Manufacturing Disruptions: Dependence on CMOs and complex synthesis of APIs increases vulnerability to supply chain disruptions.
• Patent Litigations: Ongoing patent litigations may delay generic entry or force licensing agreements, impacting supply stability.
• Global Crises: Pandemics or geopolitical conflicts (e.g., COVID-19, supply chain restrictions) pose risks to overseas manufacturing and delivery schedules.

Future Outlook and Opportunities

The market for KEPPRA XR and its generics is poised for growth due to increasing epilepsy prevalence and patient preference for extended-release formulations. Eisai is likely to continue leveraging regional manufacturing hubs and expanding licensing agreements, especially in emerging markets, to ensure robust supply chains. Additionally, technological innovations in drug formulation and manufacturing could enhance stability, scalability, and cost efficiency.

Key Takeaways

• Primary Source: Eisai Co., Ltd. remains the main supplier, with manufacturing closely regulated and localized via CMOs for capacity expansion.
• Generic Competition: Post-patent expiration has increased supply diversity, with multiple bioequivalent generics available globally.
• Supply Chain Risks: Reliance on complex manufacturing processes and regional regulations imposes risks that require careful management.
• Regulatory Standards: Strict adherence to regulatory guidelines ensures product quality and access across markets.
• Market Expansion: Continued licensing and regional manufacturing growth will sustain supply stability and meet global demand.

Frequently Asked Questions (FAQs)

1. Who are the main suppliers of KEPPRA XR?
The primary manufacturer is Eisai Co., Ltd., supporting global distribution through its own facilities and contracted CMOs. Generic companies also supply bioequivalent versions post-patent expiry.

2. Where is KEPPRA XR manufactured?
Eisai operates manufacturing sites in Japan, the U.S., and Europe, with CMOs in multiple regions including India and Europe for formulation and final product assembly.

3. Can I find KEPPRA XR from multiple suppliers?
Yes, especially in markets where patents have expired, numerous generic manufacturers produce safe, bioequivalent formulations, increasing supply options.

4. What regulatory considerations influence KEPPRA XR supply?
Manufacturers must meet strict standards set by agencies like the FDA, EMA, and PMDA, ensuring consistent quality, efficacy, and safety.

5. How does patent expiration affect KEPPRA XR supply?
Patent expiry opens market access for generics, leading to increased supply diversity, reduced prices, and broader availability, but also introduces variability in manufacturing quality.

Citations

[1] Eisai Co., Ltd. Official Website. (2023). "Keppra (levetiracetam) Extended-Release."
[2] U.S. Food and Drug Administration. (2022). "Ekprobra (levetiracetam) Extended Release: Approval History."
[3] European Medicines Agency. (2023). "KEPPRA XR: Marketing Authorization Details."
[4] GlobalData. (2023). "Pharmaceutical Supply Chain Analysis for Antiepileptic Drugs."
[5] IP Data. (2023). "Patent Status and Generic Launch Timeline for Levetiracetam in Major Markets."