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Last Updated: December 26, 2024

RUFINAMIDE Drug Patent Profile


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Which patents cover Rufinamide, and when can generic versions of Rufinamide launch?

Rufinamide is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Glenmark Pharms Ltd, Micro Labs, and Mylan. and is included in fourteen NDAs.

The generic ingredient in RUFINAMIDE is rufinamide. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the rufinamide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Rufinamide

A generic version of RUFINAMIDE was approved as rufinamide by GLENMARK PHARMS LTD on May 16th, 2016.

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Drug patent expirations by year for RUFINAMIDE
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Recent Clinical Trials for RUFINAMIDE

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SponsorPhase
Birmingham Women's and Children's NHS Foundation TrustPhase 4
Matthew's FriendsPhase 4
Guy's and St Thomas' NHS Foundation TrustPhase 4

See all RUFINAMIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for RUFINAMIDE
Paragraph IV (Patent) Challenges for RUFINAMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BANZEL Oral Suspension rufinamide 40 mg/mL 201367 1 2014-06-16
BANZEL Tablets rufinamide 200 mg and 400 mg 021911 5 2012-11-14

US Patents and Regulatory Information for RUFINAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd RUFINAMIDE rufinamide SUSPENSION;ORAL 213410-001 Feb 23, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd RUFINAMIDE rufinamide TABLET;ORAL 204964-003 Aug 17, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd RUFINAMIDE rufinamide SUSPENSION;ORAL 213457-001 Dec 18, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for RUFINAMIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eisai GmbH Inovelon rufinamide EMEA/H/C/000660
Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.
Authorised no no no 2007-01-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

RUFINAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rufinamide

Introduction

Rufinamide, marketed under the trade name BANZEL, is an antiepileptic drug primarily used as an adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy. Here, we delve into the market dynamics and financial trajectory of rufinamide, exploring its current and projected market performance, cost-effectiveness, and key factors influencing its growth.

Market Growth Projections

The global rufinamide market is anticipated to experience robust growth over the coming years. From 2024 to 2032, the market is expected to expand driven by increasing demand for innovative treatments and services in the epilepsy sector[1].

CAGR and Forecast Period

The global rufinamide market is projected to register a Compound Annual Growth Rate (CAGR) of around 3.2% during the forecast period from 2021 to 2028. This growth is attributed to the rising need for effective treatments for LGS and other epilepsy conditions[4].

Cost-Effectiveness Analysis

Rufinamide has been evaluated for its cost-effectiveness in treating LGS patients, particularly in comparison to other antiepileptic drugs like topiramate and lamotrigine.

UK NHS Perspective

A cost-effectiveness analysis from the UK NHS perspective indicates that rufinamide, despite being more costly, results in a higher number of successfully treated LGS patients. The analysis suggests that if society is willing to pay at least £250 for a 1% increase in the number of successfully treated patients, rufinamide is likely to be cost-effective with a probability of over 80%[2].

Clinical Benefits and Costs

The analysis involved an individual patient-simulation model to estimate treatment-related costs and clinical benefits over a 3-year period. Rufinamide showed higher total costs but also higher success rates in reducing seizure frequency and drop attacks compared to topiramate and lamotrigine[2].

Market Drivers

Several factors are driving the growth of the rufinamide market.

Increasing Demand for Innovative Treatments

The need for effective and innovative treatments for epilepsy, particularly for rare and difficult-to-treat conditions like LGS, is a significant driver. Rufinamide's efficacy in reducing seizure frequency and its approval for use in children as young as one year old contribute to its market demand[5].

Expanding Patient Population

The approval of rufinamide for use in younger patients (from 1 to less than 4 years old) has expanded its target population. This expansion is expected to boost sales and market growth[5].

Regulatory Approvals and Recommendations

Regulatory approvals and positive risk-benefit assessments by health authorities like the FDA further enhance the market credibility and acceptance of rufinamide. The FDA's approval of rufinamide for LGS treatment in various age groups has been a crucial factor in its market success[5].

Market Challenges

Despite the positive growth trajectory, the rufinamide market faces several challenges.

High Treatment Costs

Rufinamide is more expensive than some other antiepileptic drugs, which can be a barrier to access, especially in regions with limited healthcare budgets. However, cost-effectiveness analyses suggest that the benefits may justify the costs in many cases[2].

Side Effects and Safety Concerns

Like other antiepileptic drugs, rufinamide has side effects such as nausea, vomiting, and loss of appetite. These side effects, while manageable, can impact patient compliance and overall market perception[5].

Competitive Landscape

The antiepileptic drug market is competitive, with several drugs available for treating various forms of epilepsy.

Comparative Analysis with Other AEDs

Rufinamide is often compared to other adjunctive treatments like topiramate and lamotrigine. While it may be more costly, its efficacy in treating LGS patients makes it a viable option. Cost-utility analyses have shown that rufinamide can be a cost-effective alternative in certain scenarios[3].

Financial Performance and Revenue

The financial performance of rufinamide is closely tied to its market demand and the overall growth of the epilepsy treatment market.

Revenue Projections

Given the projected CAGR and expanding patient population, the revenue from rufinamide sales is expected to increase significantly over the forecast period. The market's robust growth from 2024 to 2032 will likely result in substantial revenue gains for manufacturers like Eisai, the developer of BANZEL[1].

Key Takeaways

  • Market Growth: The rufinamide market is expected to grow at a CAGR of around 3.2% from 2021 to 2028.
  • Cost-Effectiveness: Rufinamide is cost-effective, particularly in treating LGS patients, despite higher costs compared to some other AEDs.
  • Market Drivers: Increasing demand for innovative treatments, expanding patient population, and regulatory approvals are key drivers.
  • Challenges: High treatment costs and side effects are notable challenges.
  • Competitive Landscape: Rufinamide competes with other AEDs but stands out due to its efficacy in treating LGS.

FAQs

What is the primary use of rufinamide?

Rufinamide is primarily used as an adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome (LGS).

How does rufinamide compare to other antiepileptic drugs in terms of cost-effectiveness?

Rufinamide is more costly than some other AEDs but is considered cost-effective due to its higher success rates in treating LGS patients, particularly if society is willing to pay for the incremental benefits[2].

What age groups is rufinamide approved for?

Rufinamide is approved for use in children as young as one year old and in adults for the treatment of LGS[5].

What are the common side effects of rufinamide?

Common side effects include nausea, vomiting, and loss of appetite[5].

How is the rufinamide market expected to grow in the coming years?

The rufinamide market is projected to grow at a CAGR of around 3.2% from 2021 to 2028, driven by increasing demand and expanding patient populations[4].

Sources

  1. WICZ: Rufinamide Market 2024 | Key Elements, Scope, and Future Segmentation by 2032.
  2. PubMed: The cost effectiveness of rufinamide in the treatment of Lennox-Gastaut syndrome.
  3. PubMed: Cost-utility analysis of rufinamide versus topiramate and lamotrigine.
  4. DataIntelo: Global Rufinamide Market Research | Global Industry Analysis & Forecast.
  5. FDA: 201367 Rufinamide Clinical BPCA.

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