keppra: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872	NDA	UCB, Inc.	50474-002-63	10 VIAL, SINGLE-USE in 1 CARTON (50474-002-63) / 5 mL in 1 VIAL, SINGLE-USE	2006-08-23
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505	NDA	UCB, Inc.	50474-001-48	473 mL in 1 BOTTLE, PLASTIC (50474-001-48)	2003-10-20
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035	NDA	UCB, Inc.	50474-594-40	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-594-40)	2000-04-24
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035	NDA	UCB, Inc.	50474-595-40	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-595-40)	2000-04-24
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035	NDA	UCB, Inc.	50474-596-40	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-596-40)	2000-04-24
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035	NDA	UCB, Inc.	50474-597-66	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-597-66)	2000-04-24
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

KEPPRA, the brand name for levetiracetam, is a widely prescribed antiepileptic medication used to treat partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 2000, KEPPRA has become a mainstay in epilepsy management. Given its high demand, understanding the supply landscape—comprising originators, generic manufacturers, and regional suppliers—is critical for stakeholders across the pharmaceutical supply chain. This article provides a comprehensive overview of KEPPRA suppliers, emphasizing sourcing dynamics, manufacturing footprints, and global distribution.

Original Manufacturer and Patent Status

UCB Pharma, a Belgian biopharmaceutical company, originally developed and licensed KEPPRA (levetiracetam). UCB holds primary regulatory approvals and comprehensive manufacturing rights, establishing a foundation for the drug's international distribution. The patent protection for KEPPRA expired in many markets by 2016, paving the way for generic entry. As a result, a proliferation of generic levetiracetam manufacturers significantly expanded supply options.

Major Generic Suppliers of KEPPRA

Following patent expiration, numerous pharmaceutical companies worldwide have emerged as key generic suppliers, supplying both branded and authorized generic versions of KEPPRA. These companies vary in their manufacturing scale, geographic reach, and regulatory credentials.

1. Mylan (now part of Viatris)

Overview: Mylan became one of the earliest and most prominent generic manufacturers of levetiracetam post-patent expiry.
Manufacturing: Operates multiple production facilities worldwide, including in the United States, India, and Europe.
Regulatory Approvals: Holds approvals from the FDA, EMA, and other regulatory agencies for levetiracetam formulations.
Supply Scope: Supplies both the U.S. market under the generic name and international markets through licensing agreements.

2. Teva Pharmaceutical Industries Ltd.

Overview: Teva, a global leader in generics, offers levetiracetam as part of its extensive portfolio.
Manufacturing: Maintains manufacturing plants in Israel, India, and Europe.
Quality Assurance: Known for rigorous compliance with regulatory standards, ensuring reliable supply.
Market Distribution: Provides the drug across North America, Europe, and other regions via direct and distribution agreements.

3. Sandoz (Novartis)

Overview: Sandoz supplies levetiracetam as part of Novartis' generics arm.
Manufacturing: Active manufacturing sites in Europe and North America.
Regulatory Standing: Secures approvals for multiple formulations, including immediate-release and extended-release preparations.
Regional Focus: Primarily active across European and North American markets.

4. Dr. Reddy’s Laboratories

Overview: Based in India, Dr. Reddy’s supplies levetiracetam to diverse global markets.
Manufacturing: Operates manufacturing units complying with international standards.
Market Reach: Supplies to North America, Europe, and emerging markets, leveraging cost-effective production.

5. Sun Pharmaceutical Industries Ltd.

Overview: One of India’s largest pharmaceutical firms, Sun Pharma produces levetiracetam generics.
Manufacturing: Multiple facilities with FDA and EMA approvals.
Supply Network: Extends supply to North America, Asia, and Africa.

6. Others

Additional companies such as Lupin, Aurobindo Pharma, and Cipla also produce levetiracetam, often targeting specific regions or markets with approved formulations.

Authorized Generics and Regional Suppliers

In addition to original generic entrants, some companies produce authorized generics—identical copies of the branded drug, manufactured by the original innovator under licensing agreements or through contractual manufacturing arrangements. These are crucial in markets where brand loyalty persists or patent litigation delays generic entry.

Examples:
- UCB’s authorized generic versions are marketed in the U.S. under different labels.
- Alvogen and Torrent Pharmaceuticals have also introduced authorized and licensed generics into regional markets.

Regional and Contract Manufacturing Dynamics

Regional manufacturing hubs significantly influence KEPPRA's supply chain:

United States: FDA-approved plants primarily in the U.S. and India supply generic levetiracetam through local and imported formulations.
India: Acts as a major manufacturing hub, with firms like Dr. Reddy’s, Sun Pharma, and Lupin producing at scale for both domestic and export markets.
Europe: Suppliers such as Sandoz and Teva maintain manufacturing sites directly serving European regulatory markets.
Asia and Africa: Cost-effective producers like Aurobindo and Cipla cater to markets with specific formulations and lower price points.

Contract manufacturing arrangements between original patent holders and third-party producers further diversify supply channels, ensuring continuity during market fluctuations or regulatory delays.

Supply Challenges and Market Dynamics

While multiple suppliers contribute to a robust supply network for KEPPRA, challenges persist:

Regulatory delays: Variations in approval timelines across regions can lead to temporary shortages.
Quality compliance: Maintaining consistent quality standards demands rigorous regulatory oversight, especially with multiple regional manufacturers.
Pricing pressures: Increased competition from generics drives pricing, but also incentivizes multiple suppliers to sustain presence in the market.
Supply chain disruptions: Global geopolitical issues, logistics constraints, and pandemics can impact manufacturing and distribution.

Emerging Trends in KEPPRA Supply

Bioequivalent formulations: Development of similar formulations with improved bioavailability or patient adherence features.
Alternate manufacturing sites: Expansion into new manufacturing regions like Southeast Asia or Latin America aims to enhance supply chain resilience.
Regulatory harmonization: Efforts toward mutual recognition of approvals streamline market access across jurisdictions.

Conclusion

The KEPPRA supply landscape is characterized by a diverse array of manufacturers, ranging from pioneering generic companies like Mylan and Teva to regional players in India and Europe. The expiration of patent protections facilitated widespread generic manufacturing and regional distribution, ensuring broader access while maintaining supply stability. Ongoing regulatory, manufacturing, and geopolitical factors will influence future supply dynamics, but the current landscape demonstrates a well-established, competitive network capable of meeting global demand.

Key Takeaways

Multiple Suppliers: The global supply of KEPPRA comprises original manufacturer UCB and numerous generic producers, predominantly in India, Europe, and North America.
Market Access and Regulatory Compliance: Robust approvals across jurisdictions are necessary for sustained supply and market expansion.
Regional Manufacturing: Localized manufacturing hubs ensure regional demand is met efficiently.
Supply Chain Resilience: Diversified manufacturing and licensing agreements mitigate risks of shortages.
Future Outlook: Emerging formulations, regional production, and regulatory harmonization will shape supply stability moving forward.

FAQs

1. Who is the original manufacturer of KEPPRA?
UCB Pharma initially developed KEPPRA (levetiracetam) and held exclusive rights until patent expiration, after which numerous generics entered the market.

2. Which companies are the leading generic suppliers of levetiracetam?
Mylan (Viatris), Teva, Sandoz (Novartis), Dr. Reddy’s, and Sun Pharma are among the top generic producers globally.

3. Are there regional differences in KEPPRA suppliers?
Yes. European markets are dominated by Sandoz and Teva, while India-based firms like Dr. Reddy’s and Sun Pharma supply both domestic and export markets, including the U.S.

4. What impact does patent expiry have on the supply of KEPPRA?
Patent expiry led to proliferation of generics, increasing supply options, competition, and potentially lowering prices. It also prompted new entrants to develop authorized and licensed generics.

5. How do supply chain disruptions affect KEPPRA availability?
Disruptions from regulatory delays, geopolitical issues, or pandemics can lead to shortages, emphasizing the importance of diversified manufacturing and strategic planning.

Sources:

[1] UCB Pharma. KEPPRA (levetiracetam) prescribing information.
[2] FDA. Approved Drug Products Database.
[3] Mylan (Viatris). Drug approvals and product information.
[4] Teva Pharmaceuticals. Product portfolio.
[5] Sandoz. Generic levetiracetam regulatory filings.
[6] Dr. Reddy’s Laboratories. Corporate disclosures.
[7] Sun Pharmaceutical Industries Ltd. Annual reports and approvals.

Suppliers and packagers for keppra

keppra

Suppliers for the Pharmaceutical Drug: KEPPRA