BANZEL Drug Patent Profile

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

Banzel is a drug marketed by Eisai Inc and is included in two NDAs.

The generic ingredient in BANZEL 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 Banzel

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

Summary for BANZEL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	1
Patent Applications:	1,180
Drug Prices:	Drug price information for BANZEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BANZEL
What excipients (inactive ingredients) are in BANZEL?	BANZEL excipients list
DailyMed Link:	BANZEL at DailyMed

See drug prices for BANZEL

Recent Clinical Trials for BANZEL

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

Sponsor	Phase
Eisai Inc.	Phase 3

See all BANZEL clinical trials

Paragraph IV (Patent) Challenges for BANZEL

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 BANZEL

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	SUSPENSION;ORAL	201367-001	Mar 3, 2011	AB	RX	Yes	Yes
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008	AB	RX	Yes	Yes
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-001	Nov 14, 2008		DISCN	Yes	No

Expired US Patents for BANZEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008
Eisai Inc	BANZEL	rufinamide	SUSPENSION;ORAL	201367-001	Mar 3, 2011
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008

EU/EMA Drug Approvals for BANZEL

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

International Patents for BANZEL

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

Country	Patent Number	Title	Estimated Expiration
Turkey	9801631
Brazil	9804947
Spain	2197485

Supplementary Protection Certificates for BANZEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0994864	SPC/GB07/041	United Kingdom		PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
0994863	07C0037	France		PRODUCT NAME: MODIFICATION CRISTALLINE A DU RUFINAMIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/378/001 DU 20070116; REGISTRATION NO/DATE AT EEC: EU/1/06/378/001-016 DU 20070116
0994863	C00994863/01	Switzerland		PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009

BANZEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BANZEL (Rufinamide)

Introduction to BANZEL

BANZEL (rufinamide) is a triazole derivative antiepileptic drug (AED) used primarily for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in adults and children 1 year and older. It is structurally unrelated to other currently marketed AEDs, making it a unique option in the epilepsy treatment landscape.

Market Position of BANZEL

BANZEL is part of the broader antiepileptic drugs market, which is projected to grow significantly over the coming years. Here are some key points regarding its market position:

Global AED Market Growth

The global antiepileptic drugs market is expected to grow from $17.13 billion in 2024 to $24.85 billion by 2032, at a CAGR of 4.8%[1][4].

Segmentation and Market Share

BANZEL falls under the second-generation antiepileptic drugs segment, which holds a significant market share. Second-generation AEDs, including BANZEL, Keppra, and Lyrica, are expected to grow substantially due to their efficacy and safety profiles[1][4].

Financial Trajectory

Revenue Contribution

While specific financial data for BANZEL alone is not readily available, its contribution to the overall market can be inferred from the performance of second-generation AEDs. The second-generation segment, which includes BANZEL, is anticipated to continue its dominance due to the therapeutic benefits and relatively high approval rates of these drugs[3][4].

CAGR and Growth Prospects

The epilepsy drugs market, which includes BANZEL, is expected to grow at a CAGR of around 4.06% to 4.8% from 2024 to 2032. This growth is driven by increasing prevalence of epilepsy, rising product approvals, and enhanced diagnostic techniques[1][3][4].

Distribution Channels

Hospital Pharmacies

BANZEL is predominantly distributed through hospital pharmacies, which hold a dominant share of the AED market. The preference for hospitals due to advanced infrastructure and adequate facilities contributes to the adoption of BANZEL in these settings[1].

Retail and Online Pharmacies

In addition to hospital pharmacies, retail and online pharmacies also play a significant role in the distribution of BANZEL. The ease of access and rising preference for teleconsultation and online pharmacy facilities are expected to boost the growth of these segments[1].

Geographical Performance

North America

North America, particularly the U.S., is a key market for BANZEL. The region dominated the global AED market with a share of 48.3% in 2023, driven by the high prevalence of epilepsy and significant FDA approvals[1].

Europe and Asia Pacific

Europe and the Asia Pacific are also crucial regions for BANZEL, with expected higher CAGRs during the forecast period. Regulatory approvals and the penetration of key regional players are driving the growth in these regions[1][3].

Challenges and Opportunities

High Cost and Accessibility

One of the significant challenges facing BANZEL and other advanced epilepsy drugs is their high cost, which limits accessibility, especially in developing regions. However, ongoing advancements in drug development are yielding more effective and safer treatments, which could mitigate some of these challenges[3].

Side Effects and Patient Compliance

Some AEDs, including BANZEL, may have side effects that affect patient compliance. For instance, BANZEL has been associated with weight loss, decreased appetite, and other adverse events. However, these side effects are generally manageable, and the overall safety profile of BANZEL remains favorable[2].

Competitive Landscape

BANZEL competes in a market dominated by major pharmaceutical companies such as UCB S.A., Pfizer Inc., and GSK plc. Pfizer’s Lyrica, although its patent expired in 2019, remains a significant competitor. However, BANZEL’s unique mechanism of action and therapeutic benefits help it maintain a strong market presence[1][3].

Key Takeaways

• Market Growth: The global AED market, including BANZEL, is projected to grow at a CAGR of 4.8% from 2024 to 2032.
• Segment Dominance: Second-generation AEDs, which include BANZEL, hold a significant market share due to their efficacy and safety.
• Distribution: Hospital pharmacies dominate the distribution, with retail and online pharmacies also contributing to the market growth.
• Geographical Performance: North America, Europe, and the Asia Pacific are key regions driving the market growth.
• Challenges: High cost and side effects are challenges, but ongoing drug development is addressing these issues.

FAQs

Q: What is the projected growth rate of the global antiepileptic drugs market? A: The global antiepileptic drugs market is expected to grow at a CAGR of 4.8% from 2024 to 2032[1].

Q: Which segment dominates the antiepileptic drugs market? A: The second-generation antiepileptic drugs segment, which includes BANZEL, dominates the market[1][4].

Q: What are the main distribution channels for BANZEL? A: Hospital pharmacies are the dominant distribution channel, followed by retail and online pharmacies[1].

Q: Which regions are driving the growth of the antiepileptic drugs market? A: North America, Europe, and the Asia Pacific are the key regions driving the market growth[1][3].

Q: What are some of the challenges facing BANZEL and other antiepileptic drugs? A: High cost, limited accessibility, and potential side effects are some of the challenges facing these drugs[3].

Cited Sources

1. Fortune Business Insights: Antiepileptic Drugs [AED] Market Size, Trends | Forecast, 2032
2. FDA: 201367 Rufinamide Clinical BPCA
3. SNS Insider: Epilepsy Drugs Market Size, Share & Growth Report 2032
4. Straits Research: Antiepileptic Drugs (AED) Market Size to Grow at a CAGR of 4.12 ...