RUFINAMIDE - Generic Drug Details

What are the generic drug sources for rufinamide and what is the scope of freedom to operate?

Rufinamide is the generic ingredient in two branded drugs marketed by Eisai Inc, 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 sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for rufinamide. Twelve suppliers are listed for this compound.

Summary for RUFINAMIDE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	16
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	12
Patent Applications:	1,739
Drug Prices:	Drug price trends for RUFINAMIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RUFINAMIDE
What excipients (inactive ingredients) are in RUFINAMIDE?	RUFINAMIDE excipients list
DailyMed Link:	RUFINAMIDE at DailyMed

See drug prices for RUFINAMIDE

Recent Clinical Trials for RUFINAMIDE

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

Sponsor	Phase
Central Manchester University Hospitals NHS Foundation Trust	Phase 4
Sheffield Children's NHS Foundation Trust	Phase 4
Birmingham Women's and Children's NHS Foundation Trust	Phase 4

See all RUFINAMIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for RUFINAMIDE

N03AF	Carboxamide derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	AB	RX	Yes	No
Mylan	RUFINAMIDE	rufinamide	TABLET;ORAL	205095-002	May 16, 2016	AB	RX	No	No
Lupin Ltd	RUFINAMIDE	rufinamide	TABLET;ORAL	204964-002	Aug 17, 2022	AB	RX	No	No
Hikma	RUFINAMIDE	rufinamide	TABLET;ORAL	204988-001	May 16, 2016	AB	RX	No	No
Bionpharma	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	211388-001	Apr 23, 2019	AB	RX	No	No
Lupin Ltd	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	213457-001	Dec 18, 2020	AB	RX	No	No
Micro Labs	RUFINAMIDE	rufinamide	TABLET;ORAL	216688-002	May 15, 2023	AB	RX	No	No

Expired US Patents for RUFINAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	7,750,028*PED
Eisai Inc	BANZEL	rufinamide	SUSPENSION;ORAL	201367-001	Mar 3, 2011	6,740,669*PED
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008	8,076,362*PED
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008	7,750,028*PED
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	6,740,669*PED
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	8,076,362*PED
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-001	Nov 14, 2008	8,076,362*PED

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

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.