LEVETIRACETAM IN SODIUM CHLORIDE Drug Patent Profile

When do Levetiracetam In Sodium Chloride patents expire, and what generic alternatives are available?

Levetiracetam In Sodium Chloride is a drug marketed by B Braun Medical Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, and Nexus. and is included in eight NDAs.

The generic ingredient in LEVETIRACETAM IN SODIUM CHLORIDE is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Levetiracetam In Sodium Chloride

A generic version of LEVETIRACETAM IN SODIUM CHLORIDE was approved as levetiracetam by MYLAN on November 4^th, 2008.

Summary for LEVETIRACETAM IN SODIUM CHLORIDE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	225
Patent Applications:	3,497
DailyMed Link:	LEVETIRACETAM IN SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for LEVETIRACETAM IN SODIUM CHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 4
AgeneBio	Phase 2
McMaster University	Phase 3

See all LEVETIRACETAM IN SODIUM CHLORIDE clinical trials

Pharmacology for LEVETIRACETAM IN SODIUM CHLORIDE

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for LEVETIRACETAM IN SODIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun Medical Inc	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	209705-001	Feb 27, 2024	AP	RX	No	No
Hikma	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	211356-001	Feb 12, 2024	AP	RX	No	No
Nexus	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	213532-003	Jul 6, 2020	AP	RX	No	No

EU/EMA Drug Approvals for LEVETIRACETAM IN SODIUM CHLORIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma SA	Keppra	levetiracetam	EMEA/H/C/000277 Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Keppra is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	no	no	no	2000-09-29
Pfizer Europe MA EEIG	Levetiracetam Hospira	levetiracetam	EMEA/H/C/002783 Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.Levetiracetam Hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.	Authorised	yes	no	no	2014-01-07
Accord Healthcare S.L.U.	Levetiracetam Accord	levetiracetam	EMEA/H/C/002290 Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03

LEVETIRACETAM IN SODIUM CHLORIDE Market Analysis and Financial Projection

Levetiracetam in Sodium Chloride: Market Dynamics and Financial Trajectory

Market Overview

Levetiracetam, marketed under the trade name Keppra, is a pyrrolidine-class drug used to treat various types of seizures associated with epileptic disorders. The market for levetiracetam, particularly in its formulation with sodium chloride, is characterized by several key dynamics and a promising financial trajectory.

Market Size and Growth

The global levetiracetam market is expected to experience significant growth over the forecast period from 2022 to 2029. The market size is projected to expand at a remarkable CAGR, driven by increasing demand for effective antiepileptic drugs. By 2029, the market is anticipated to reach substantial revenue, with sales and revenue forecasts indicating a robust growth trajectory[1][5].

Segmentation by Type and Application

The levetiracetam market is segmented by type, including tablets, injections, and solutions. The injection form, particularly the concentrate for injection in 5-mL single-use vials, is a significant segment. These vials must be diluted in a compatible diluent before intravenous infusion[2].

In terms of application, levetiracetam is primarily used for the treatment of myoclonic seizures, tonic-clonic seizures, and other epileptic disorders. The market profile for these applications indicates a high demand driven by the need for effective seizure management[1][5].

Geographical Distribution

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region exhibits different growth rates and market shares, with Asia-Pacific expected to be a key growth driver due to increasing healthcare expenditure and a large patient population[1][5].

Market Dynamics

Drivers

• Increasing Prevalence of Epilepsy: The rising incidence of epilepsy and related seizures drives the demand for effective antiepileptic drugs like levetiracetam.
• Advancements in Healthcare: Improvements in healthcare infrastructure and access to advanced treatments in emerging markets contribute to market growth.
• Cost-Effectiveness: Studies have shown that levetiracetam can be cost-effective by reducing the need for surgical evaluations and surgeries, thereby saving healthcare costs[4].

Restraints

• Side Effects and Adverse Reactions: Levetiracetam can have side effects such as dizziness, fatigue, and behavioral changes, which may limit its adoption.
• Competition from Generic Drugs: The presence of generic versions of levetiracetam can reduce the market share of branded products.

Opportunities

• Emerging Markets: Growing healthcare needs in developing countries present significant opportunities for market expansion.
• Research and Development: Continuous R&D in antiepileptic drugs can lead to new formulations and applications, further boosting the market.

Challenges

• Regulatory Hurdles: Strict regulatory requirements and approval processes can delay market entry for new products.
• Economic Factors: Economic downturns can affect healthcare spending and impact market growth.

Financial Trajectory

Revenue and Sales

The global levetiracetam market is expected to generate substantial revenue over the forecast period. Sales are anticipated to increase, driven by the growing demand for antiepileptic treatments. The revenue status and outlook from 2022 to 2029 indicate a positive financial trajectory, with significant growth projected in all major regions[1][5].

Cost-Effectiveness Analysis

A cost-effectiveness analysis of levetiracetam as an add-on therapy for refractory epilepsy has shown that the drug can provide significant savings by reducing the number of surgical evaluations and surgeries. The incremental cost-effectiveness ratio (ICER) for levetiracetam was found to be approximately $80.7 per seizure-free day gained per patient per year, indicating a favorable cost-benefit profile[4].

Key Players and Competitive Landscape

The levetiracetam market is dominated by several key players, including major pharmaceutical companies. These companies focus on product innovation, pricing strategies, and market penetration to maintain their market share. The competitive landscape is characterized by intense competition, with companies also investing in R&D to develop new formulations and applications[1][5].

Market Forecast

The market forecast for levetiracetam from 2022 to 2029 is optimistic, with projections indicating significant growth. The forecast covers sales and revenue by type, application, and geographical region, providing a comprehensive overview of the market's future prospects[1][5].

Conclusion

The market for levetiracetam in sodium chloride is poised for robust growth, driven by increasing demand for effective antiepileptic treatments and favorable cost-effectiveness profiles. Despite challenges such as side effects and competition from generics, the market is expected to expand significantly over the forecast period.

Key Takeaways

• Growing Demand: Increasing prevalence of epilepsy drives the demand for levetiracetam.
• Cost-Effectiveness: Levetiracetam can reduce healthcare costs by minimizing the need for surgical interventions.
• Geographical Expansion: Emerging markets offer significant growth opportunities.
• Competitive Landscape: Key players focus on innovation and market penetration to maintain their share.
• Positive Financial Trajectory: The market is expected to generate substantial revenue over the forecast period.

FAQs

What is levetiracetam used for?

Levetiracetam is used to treat various types of seizures associated with epileptic disorders, including myoclonic and tonic-clonic seizures.

How is levetiracetam administered?

Levetiracetam is available as a concentrate for injection in 5-mL single-use vials, which must be diluted in a compatible diluent before intravenous infusion.

What are the key drivers of the levetiracetam market?

The key drivers include the increasing prevalence of epilepsy, advancements in healthcare, and the cost-effectiveness of the drug in reducing surgical evaluations and surgeries.

Who are the major players in the levetiracetam market?

The market is dominated by several major pharmaceutical companies that focus on product innovation and market penetration.

What is the forecasted growth rate of the levetiracetam market?

The market is expected to grow at a remarkable CAGR from 2022 to 2029, driven by increasing demand and favorable market dynamics.

Sources

1. GlobeNewswire: Levetiracetam Market Size and Outlook to 2022-2029.
2. ASHP: Levetiracetam Monograph.
3. PubChem: Levetiracetam.
4. PubMed: Economic evaluation of levetiracetam as an add-on therapy in refractory epilepsy.
5. Market Research Intellect: Global Levetiracetam Drugs Market Size, Trends and Projections.