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, Baxter Hlthcare Corp, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hq Spclt Pharma, and Nexus. and is included in nine NDAs.

The generic ingredient in LEVETIRACETAM IN SODIUM CHLORIDE is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-four 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:	9
NDAs:	9
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	247
Patent Applications:	4,492
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
Beijing Tiantan Hospital	PHASE3
Nebraska Methodist Health System	PHASE3
Fundacin de Investigacin Biomdica - Hospital Universitario de La Princesa	PHASE3

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
Nexus	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	213532-001	Jul 6, 2020	AP	RX	No	No
B Braun Medical	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	209705-001	Feb 27, 2024	AP	RX	No	No
Gland	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	206880-001	Oct 25, 2017	AP	RX	No	No
Hq Spclt Pharma	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	202543-004	Dec 14, 2020		DISCN	Yes	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/000277Keppra 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/002783Levetiracetam 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/002290Levetiracetam 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
Pharmathen S.A.	Matever	levetiracetam	EMEA/H/C/002024Matever 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.Matever 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

Market Dynamics and Financial Trajectory for Levetiracetam in Sodium Chloride

Last updated: July 29, 2025

Introduction

Levetiracetam, marketed primarily under the brand name Keppra, is an antiepileptic drug widely prescribed for seizure management. Its formulation in sodium chloride solutions is increasingly pivotal for hospitalized patients requiring parenteral therapy, further expanding its clinical utility beyond oral administration. Understanding the evolving market landscape and financial prospects surrounding levetiracetam in sodium chloride involves analyzing factors such as demand drivers, regulatory pathways, competitive dynamics, manufacturing complexities, and pricing trends.

Market Overview

The global antiepileptic drugs (AEDs) market, valued at approximately USD 5.4 billion in 2022, is projected to grow at a CAGR of 4.3% through 2030, driven by rising epilepsy prevalence, aging populations, and technological innovations (source: ResearchAndMarkets, 2022). Levetiracetam accounts for a substantial share of this market, owing to its favorable safety profile and broad-spectrum efficacy.

The inclusion of levetiracetam in sodium chloride solutions marks a significant modality shift, prioritizing parenteral use in acute care settings. This injectable form is particularly relevant in intensive care units (ICUs), emergency departments, and perioperative contexts where rapid therapeutic intervention is essential.

Market Drivers

Increasing Incidence of Epilepsy and Neurological Disorders

Approximately 50 million people worldwide suffer from epilepsy, making AEDs a critical need (WHO, 2021). The rise in neurological disorders, compounded by an aging demographic, accelerates demand for effective treatments such as levetiracetam.

Expansion of Parenteral Formulations

The clinical advantages of injectable levetiracetam—such as rapid onset, high bioavailability, and minimal drug interactions—are catalyzing its adoption in acute care. The formulation in sodium chloride solutions simplifies administration and aligns with hospital protocols, further boosting demand.

Regulatory Approvals and Off-Label Indications

Regulatory agencies like the FDA and EMA have approved IV formulations of levetiracetam for acute seizure management, fostering new prescribing pathways. Additionally, ongoing research into off-label uses, including status epilepticus and neurocritical care, enhances market prospects.

Emerging Markets and Healthcare Infrastructure Growth

Rapid expansion of healthcare infrastructure, particularly in Asia-Pacific regions, presents new opportunities. Favorable reimbursement policies and increased healthcare spending also support market growth.

Market Challenges

Pricing Pressures and Patent Expirations

Generic versions of oral levetiracetam entered the market post-patent expiration in 2014, exerting downward pressure on prices. Similar trends are anticipated for injectable formulations once exclusivity lapses.

Manufacturing and Supply Chain Complexities

Formulating levetiracetam in sodium chloride solutions entails complex manufacturing processes, procurement of high-quality active pharmaceutical ingredients (APIs), and rigorous stability testing. Disruptions in supply chains can influence market availability and pricing.

Competition from Alternative AEDs

Drug alternatives such as lacosamide, phenobarbital, and phenytoin pose competitive threats, especially in critical care settings. The preference for newer or more cost-effective options can influence market share.

Regulatory Barriers and Reimbursement Landscape

Variability in regulatory approval timelines and reimbursement policies across regions may impact market penetration and profitability.

Financial Trajectory

Revenue Projections

Based on current demand patterns and clinical adoption rates, revenues for levetiracetam in sodium chloride solutions are expected to grow at a CAGR of approximately 5.0% reaching USD 350-400 million globally by 2030. The initial growth phase is driven by hospital uptake, while mature markets may stabilize due to pricing pressures.

Pricing Dynamics

Injectable forms tend to command premium pricing due to production complexity and critical usage applications. However, generic competition is anticipated to erode margins, emphasizing the importance of patent strategies and value-added differentiations.

Investment and R&D Outlook

Pharmaceutical companies are investing in formulation enhancements, such as stability improvements and bioavailability studies, to prolong exclusivity and optimize market share. Development of biosimilars or combination therapies could also diversify revenue streams.

Market Expansion Opportunities

Emerging markets—like China, India, and Brazil—offer significant growth potential driven by increased healthcare infrastructure investments and rising epilepsy prevalence. Strategic partnerships and local manufacturing can facilitate entry and sustain profitability.

Regulatory and Patent Landscape

The patent for Keppra, the flagship brand of levetiracetam, expired in multiple jurisdictions by 2014, paving the way for generics. However, manufacturers seek new formulations or delivery mechanisms—such as the sodium chloride solutions—to secure supplementary exclusivity periods through method-of-use or formulation patents, which can influence financial trajectories.

Competitive Landscape

Global pharmaceutical players, including UCB, Teva, Sandoz, and Mylan, dominate the market for levetiracetam products. Their strategies encompass patent litigation, licensing, and pipeline development to strengthen market positioning. Novel formulations, such as levetiracetam in sodium chloride, need differentiation to carve out sustainable market share amid generic competition.

Market Outlook Summary

The future of levetiracetam in sodium chloride hinges on clinical adoption rates, regulatory support, and manufacturing scalability. While competitive pressures are intense, clinical advantages and targeted hospital use mean the drug's niche remains promising. Strategic positioning, global expansion, and ongoing innovation will determine financial success over the coming decade.

Key Takeaways

• Growing Demand: Rising epilepsy and neurological disorder prevalence underpin sustained market need for levetiracetam, especially in parenteral forms.
• Product Differentiation: Formulation improvements and clinical advantages in sodium chloride solutions can secure competitive edges in acute care settings.
• Market Challenges: Patent expirations, pricing pressures, and competition from alternative AEDs necessitate strategic planning.
• Emerging Markets: Expanding healthcare infrastructure in developing regions offers substantial growth opportunities.
• Innovation & Regulation: Ongoing R&D and favorable regulatory pathways will influence the long-term financial trajectory.

FAQs

1. What advantages does levetiracetam in sodium chloride offer over other formulations?
   It provides rapid administration, high bioavailability, and ease of infusion in acute or critical care environments, enhancing its suitability for hospital settings.

2. How will patent expirations affect the market for levetiracetam in sodium chloride?
   Patent expirations will likely lead to increased generic competition, exerting downward pressure on prices and shrinking profit margins, unless novel formulations or delivery methods are protected by new patents.

3. What are the primary regions for growth in levetiracetam injections?
   The Asia-Pacific region, Latin America, and the Middle East are poised for significant growth due to expanding healthcare infrastructure and rising neurological disease rates.

4. Are there significant regulatory hurdles in expanding the use of levetiracetam in sodium chloride?
   Regulatory approval hinges on demonstrating safety, efficacy, and manufacturing quality. While approved in many jurisdictions, evolving guidelines and regional differences can pose challenges.

5. How do competitive AED options impact the financial outlook?
   Alternatives like lacosamide and phenobarbital can challenge market share, emphasizing the need for differentiation and cost-effective positioning to sustain profitability.

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Sources:
[1] ResearchAndMarkets (2022). Global Antiepileptic Drugs Market Report.
[2] World Health Organization (2021). Epilepsy Fact Sheet.
[3] U.S. Food and Drug Administration (FDA). Keppra (levetiracetam) Prescribing Information.
[4] MarketWatch, 2023. Pharmaceutical Market Trends.
[5] EvaluatePharma, 2023. Pipeline and Patent Data.