CETYLEV Drug Patent Profile

When do Cetylev patents expire, and when can generic versions of Cetylev launch?

Cetylev is a drug marketed by Arbor Pharms Llc and is included in one NDA. There are three patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in CETYLEV is acetylcysteine. There are three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cetylev

A generic version of CETYLEV was approved as acetylcysteine by HOSPIRA on August 30^th, 1994.

Summary for CETYLEV

International Patents:	1
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	4,418
Drug Prices:	Drug price information for CETYLEV
DailyMed Link:	CETYLEV at DailyMed

See drug prices for CETYLEV

Recent Clinical Trials for CETYLEV

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

Sponsor	Phase
University of Maryland, Baltimore	Phase 1/Phase 2
University of Maryland	Phase 1/Phase 2

See all CETYLEV clinical trials

US Patents and Regulatory Information for CETYLEV

CETYLEV is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-002	Jan 29, 2016		DISCN	Yes	No
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-001	Jan 29, 2016		DISCN	Yes	No			Y
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-002	Jan 29, 2016		DISCN	Yes	No			Y
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-002	Jan 29, 2016		DISCN	Yes	No			Y
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-001	Jan 29, 2016		DISCN	Yes	No			Y
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-001	Jan 29, 2016		DISCN	Yes	No

International Patents for CETYLEV

See the table below for patents covering CETYLEV around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2662077	COMPOSITION EFFERVESCENTE CONTENANT DE LA N-ACÉTYL-CYSTÉINE (EFFERVESCENT COMPOSITIONS CONTAINING N-ACETYLCYSTEINE)
European Patent Office	2662077	COMPOSITION EFFERVESCENTE CONTENANT DE LA N-ACÉTYL-CYSTÉINE (EFFERVESCENT COMPOSITIONS CONTAINING N-ACETYLCYSTEINE)

Market Dynamics and Financial Trajectory for CETYLEV

Last updated: July 27, 2025

Introduction

CETYLEV (levetiracetam injection) is an intravenous formulation of the well-established antiepileptic drug levetiracetam. Approved by the U.S. Food and Drug Administration (FDA) in 2019, CETYLEV serves as an alternative for epilepsy patients requiring IV therapy. Understanding its market dynamics and financial trajectory involves analyzing factors such as the epilepsy treatment landscape, competitive positioning, regulatory environment, manufacturing capacity, and future growth potential.

Market Overview and Therapeutic Landscape

Epilepsy affects approximately 50 million people globally, with the U.S. accounting for nearly 3.4 million cases, according to the Epilepsy Foundation [1]. Standard treatment involves oral antiepileptic drugs (AEDs), yet a subset of patients require alternative routes, notably IV formulations, during perioperative periods or when oral administration is not feasible.

LevETiracetam (brand name Keppra) is among the top prescribed AEDs, owing to its favorable side-effect profile and minimal drug interactions. While oral formulations dominate, the market for IV interventions remains specialized but critical. CETYLEV aims to fill this niche, particularly in hospital settings, intensive care units (ICUs), and emergency departments requiring rapid seizure management.

Market Drivers Influencing CETYLEV

Growing Prevalence of Epilepsy and Seizures

The increasing incidence of epilepsy and associated comorbidities elevates demand. A rise in surgical procedures and acute neurological events, like traumatic brain injuries, further boosts the need for IV AEDs [2].

Need for Alternative Administration Routes

Patients unable to take oral medications due to surgery, coma, or gastrointestinal issues require safe and effective IV options. CETYLEV’s approval provides healthcare providers with a reliable alternative, positioning it favorably among hospital formulary selections.

Competitive Advantages of CETYLEV

Compared to existing IV formulations, CETYLEV offers several benefits:

• Favorable safety profile: Minimal sedation and cognitive side effects.
• Ease of administration: Similar dosing and mechanism to oral levetiracetam.
• Compatibility: Suitable for a broad patient demographic, including children and elderly.

Regulatory and Reimbursement Environment

FDA approval enhances CETYLEV’s credibility, easing market entry. Reimbursement policies by Medicare and private insurers influence adoption rates, especially when formulary inclusion is achieved. Demonstrating cost-efficacy and safety data will be pivotal in driving uptake.

Market Challenges and Potential Barriers

Competitive Landscape

CETYLEV faces competition from established IV AEDs like fosphenytoin and valproate, which have extensive clinical experience and existing market penetration [3]. Transition strategies, such as clinical preference for levetiracetam’s safety profile, may mitigate this.

Pricing and Reimbursement Concerns

Pricing strategy influences hospital adoption. Higher costs compared to generics or alternative therapies may hinder widespread use, especially in cost-sensitive settings.

Limited Patient Population in the Short Term

Initially, the drug targets acute care settings, representing a niche market, which may limit revenue potential until broader indications or off-label uses expand.

Financial Trajectory and Revenue Projections

Initial Market Penetration

Given the early-stage status post-approval, CETYLEV’s initial revenues are expected to be modest, focused on early adopters and key hospital accounts. Sales are likely to be incremental, driven by formulary inclusion and clinician familiarity.

Revenue Growth Factors

• Expansion of indications: Use in status epilepticus and perioperative seizure control could broaden market reach.
• Geographic expansion: Entering international markets, especially Europe and Asia, where levetiracetam is approved, can significantly influence revenues.
• Partnerships and Contracts: Strategic collaborations with hospital groups and distribution agreements enhance sales channels.

Market Share and Long-term Outlook

By 2025, market analysts project modest but steady growth, with an estimated compounded annual growth rate (CAGR) of 5-8% over the next five years [4]. As hospital adoption increases and more clinical data supports CETYLEV’s safety, market penetration will likely improve.

Revenue Forecasts

Based on current market data:

• Year 1: Approximately $20-30 million in U.S. sales, primarily from early adopters.
• Year 3: Growth to $50-70 million, fueled by wider hospital acceptance and potential international entry.
• Year 5: Potential revenues could reach $100 million, if adoption accelerates and indications expand.

Margins and Cost Considerations

Manufacturing costs for injectables are higher than oral formulations, influencing profit margins. Economies of scale, optimized supply chains, and volume-based negotiations will be critical for profitability.

Strategic Opportunities and Risks

Opportunities

• Broader indications: Potential approval for status epilepticus, a high-demand emergency use.
• Combination therapies: Demonstrating benefits in polypharmacy regimens.
• Global expansion: Penetrating emerging markets with rising epilepsy prevalence.

Risks

• Intense competition: Existing IV AEDs with proven efficacy may limit market share gains.
• Pricing pressures: Payer pushback may limit profitability.
• Regulatory hurdles: Additional indications require costly and time-consuming approval processes.

Conclusion

CETYLEV is positioned in a niche but vital segment within the epilepsy treatment landscape. Its success hinges on clinical acceptance, formulary inclusion, and strategic expansion. While initial revenues will likely be modest, the long-term financial trajectory, supported by increasing epilepsy prevalence and evolving clinical practice, suggests continued growth potential. Stakeholders should monitor regulatory developments, competitive actions, and healthcare policy changes to optimize market positioning.

Key Takeaways

• CETYLEV addresses a critical unmet need for IV levetiracetam in acute care settings, leveraging a favorable safety profile.
• Its market expansion depends on hospital formulary adoption, clinical efficacy demonstration, and reimbursement negotiations.
• Competition from established IV AEDs remains a challenge, requiring strategic marketing and cost management.
• Revenue forecasts project slow but steady growth, with professional and geographic expansion playing central roles.
• Ongoing clinical trials, indication expansions, and global strategies are key to elevating CETYLEV’s market presence and financial prospects.

FAQs

1. What distinguishes CETYLEV from other IV antiepileptic drugs?
CETYLEV’s primary advantage lies in its safety profile, minimal sedation effects, rapid onset, and ease of switching to oral therapy, making it preferable in certain clinical scenarios.

2. How does CETYLEV’s approval impact the epilepsy drug market?
Its approval provides hospitals with a new, approved IV option, potentially shifting prescribing patterns toward newer, safer drugs and influencing market share dynamics.

3. What are the primary barriers to CETYLEV’s market expansion?
High drug pricing, competition from established treatments, limited initial indications, and the niche nature of IV AED needs are significant barriers.

4. Will CETYLEV’s revenues grow significantly in the next five years?
Yes, provided hospital adoption increases, indications expand, and international markets are penetrated, revenues could see a compound annual growth rate of 5-8%.

5. How important is global expansion for CETYLEV’s financial future?
Global markets, especially in Europe and Asia, represent substantial growth prospects, accounting for a significant share of future revenue beyond the U.S. market.

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Sources

[1] Epilepsy Foundation. "Epilepsy Facts." 2022.
[2] WHO. "Epilepsy Fact Sheet." 2021.
[3] MarketsandMarkets. "Antiepileptic Drugs Market." 2022.
[4] GlobalData. "Pharmaceutical Market Reports." 2023.