APTIOM Drug Patent Profile

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

Aptiom is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred patent family members in twenty-six countries.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aptiom

A generic version of APTIOM was approved as eslicarbazepine acetate by DR REDDYS on June 29^th, 2021.

Summary for APTIOM

International Patents:	100
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	3
Patent Applications:	226
Drug Prices:	Drug price information for APTIOM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APTIOM
What excipients (inactive ingredients) are in APTIOM?	APTIOM excipients list
DailyMed Link:	APTIOM at DailyMed

See drug prices for APTIOM

Recent Clinical Trials for APTIOM

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

Sponsor	Phase
Sunovion	Phase 3
Stanford University	Phase 4
Sunovion	Phase 4

See all APTIOM clinical trials

Pharmacology for APTIOM

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for APTIOM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APTIOM	Tablets	eslicarbazepine acetate	200 mg, 400 mg, 600 mg and 800 mg	022416	7	2017-11-08

US Patents and Regulatory Information for APTIOM

APTIOM is protected by fifteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	AB	RX	Yes	No			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	AB	RX	Yes	No
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	AB	RX	Yes	Yes			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	AB	RX	Yes	No				Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	AB	RX	Yes	No			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	AB	RX	Yes	No			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	AB	RX	Yes	No

Expired US Patents for APTIOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013

EU/EMA Drug Approvals for APTIOM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
BIAL - Portela & Ca, S.A.	Zebinix	eslicarbazepine acetate	EMEA/H/C/000988 Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.	Authorised	no	no	no	2009-04-21
BIAL - Portela Ca, S.A.	Exalief	eslicarbazepine acetate	EMEA/H/C/000987 Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.	Withdrawn	no	no	no	2009-04-21

International Patents for APTIOM

When does loss-of-exclusivity occur for APTIOM?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering APTIOM around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2546521	ЛЕКАРСТВЕННЫЕ ФОРМЫ ДЛЯ ПЕРОРАЛЬНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ АЦЕТАТ ЛИКАРБАЗЕПИНА (DOSAGE FORMS FOR ORAL APPLICATION CONTAINING LICARBAZEPINE ACETATE)
Japan	6043758
Brazil	PI0520258	uso de uma composição farmacêutica, método para preparar uma composição farmacêutica, e, uso de uma quantidade eficaz de acetato de eslicarbazepina
Poland	185476
Poland	2214636
European Patent Office	2319836	Reduction catalytique asymetrique d'oxcarbazepine (Asymmetric catalytic reduction of oxcarbazepine)
New Zealand	578331	THERAPEUTICAL USES OF ESLICARBAZEPINE

Supplementary Protection Certificates for APTIOM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0751129	SPC/GB09/047	United Kingdom		PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTERED: UK EU/1/09/514/001 20090421; UK EU/1/09/514/002 20090421; UK EU/1/09/514/003 20090421; UK EU/1/09/514/004 20090421; UK EU/1/09/514/005 20090421; UK EU/1/09/514/006 20090421; UK EU/1/09/514/019 20090421; UK EU/1/09/514/020 20090421; UK EU/1/09/514/013 20090421; UK EU/1/09/514/014 20090421; UK EU/1/09/514/015 20090421; UK EU/1/09/514/016 20090421; UK EU/1/09/514/017 20090421; UK EU/1/09/514/018 20090421; UK EU/1/09/514/007 20090421; UK EU/1/09/514/008 20090421; UK EU/1/09/514/009 20090421; UK EU/1/09/514/010 20090421; UK EU/1/09/514/011 20090421; UK EU/1/09/514/012 20090421
0751129	09C0040	France		PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/514/001 DU 20090421; REGISTRATION NO/DATE AT EEC: EU/1/09/514/001 DU 20090421
0751129	C300406	Netherlands		PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
0751129	CA 2009 00023	Denmark
2214636	C02214636/01	Switzerland		PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020
0751129	SPC027/2009	Ireland		SPC027/2009: 20091119, EXPIRES: 20210627
1915346	C01915346/01	Switzerland		PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020

Market Dynamics and Financial Trajectory for APTIOM (Eslicarbazepine Acetate)

Introduction

APTIOM, also known as eslicarbazepine acetate, is a sodium channel inhibitor approved for the adjunctive treatment of partial-onset seizures in the US and Europe. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Overview

The antiepileptic drugs market, which includes APTIOM, is forecasted to grow significantly over the next few years. The market is expected to reach $19,814 million by 2030, growing at a CAGR of 2.60% during the forecast period of 2024-2030[1].

Drug Classification and Approval

APTIOM is classified as a second-generation antiepileptic drug. It was discovered and developed by BIAL and is marketed by Sunovion Pharmaceuticals Inc. in the US and Canada. The drug received FDA approval in November 2013 for the adjunctive treatment of partial-onset seizures[4].

Clinical Trials and Efficacy

The FDA approval of APTIOM was based on three phase III clinical trials (Studies 301, 302, and 304) that enrolled over 1,400 patients. These studies demonstrated the efficacy of APTIOM in reducing the frequency of partial-onset seizures when used as an adjunctive treatment[4].

Market Segmentation

By Drug Type

APTIOM falls under the second-generation antiepileptic drugs category, which is a significant segment in the market. As patents for second-generation drugs expire, companies are focusing more on the development of third-generation drugs, but second-generation drugs like APTIOM continue to hold a substantial market share[1].

By Form and Administration

APTIOM is available in tablet form and is administered orally. The oral administration route is the most common and preferred method for antiepileptic drugs, contributing to the drug's market appeal[1].

Geographic Market

North America

North America, particularly the US and Canada, holds a significant share of the antiepileptic drugs market, including APTIOM. The region's robust healthcare infrastructure and high living standards contribute to its market dominance[1].

Asia-Pacific

While North America leads in terms of current market share, the Asia-Pacific region is expected to offer lucrative growth opportunities over the forecast period. This growth is driven by an increasing prevalence of neurological disorders in countries like India, Bangladesh, and Pakistan[1].

Financial Performance

Sales and Revenue

Sales of APTIOM have shown positive trends. For instance, Sumitomo Pharma reported an increase in APTIOM sales due to the true-up of rebates and other factors in the first quarter of FY2024. This indicates a stable and growing revenue stream for the drug[5].

Research and Development

The financial performance of companies like Sunovion Pharmaceuticals, which markets APTIOM, is influenced by research and development expenses. While these expenses can be significant, they are crucial for maintaining and expanding the drug's market position[2].

Competitive Landscape

The antiepileptic drugs market is competitive, with various drugs available for different types of seizures. APTIOM competes with other second-generation drugs like Vimpat, Lyrica, and Keppra. However, its unique mechanism of action and clinical trial data support its position in the market[1].

Pricing and Affordability

The pricing of antiepileptic drugs, including APTIOM, is influenced by demand and the willingness to pay among patients and healthcare providers. As more competitors enter the market and patents expire, prices are expected to decline, making these drugs more accessible to a broader patient population[3].

Challenges and Opportunities

Side Effects and Patient Compliance

One of the challenges facing APTIOM and other antiepileptic drugs is the potential for side effects, which can impact patient compliance. However, clinical trials have shown that APTIOM has a favorable side effect profile compared to some other antiepileptic drugs[4].

Market Expansion

The growing prevalence of neurological disorders and the increasing awareness of epilepsy treatment options present significant opportunities for market expansion. Digitalization and the rise of online pharmacies also offer new distribution channels that can enhance the drug's reach[1].

Key Takeaways

• Market Growth: The antiepileptic drugs market, including APTIOM, is expected to grow at a CAGR of 2.60% from 2024 to 2030.
• Clinical Efficacy: APTIOM has demonstrated efficacy in reducing partial-onset seizures through phase III clinical trials.
• Geographic Dominance: North America currently leads the market, but the Asia-Pacific region is poised for significant growth.
• Financial Performance: Sales of APTIOM have been increasing, supported by rebates and other financial factors.
• Competitive Landscape: APTIOM competes with other second-generation antiepileptic drugs but maintains a strong market position due to its unique mechanism and clinical data.

FAQs

1. What is APTIOM used for? APTIOM (eslicarbazepine acetate) is used as an adjunctive treatment for partial-onset seizures in patients with epilepsy.

2. Who developed and markets APTIOM? APTIOM was developed by BIAL and is marketed by Sunovion Pharmaceuticals Inc. in the US and Canada.

3. What are the key clinical trials that led to the FDA approval of APTIOM? The FDA approval of APTIOM was based on three phase III clinical trials (Studies 301, 302, and 304) that enrolled over 1,400 patients.

4. How does the pricing of APTIOM compare to other antiepileptic drugs? The pricing of APTIOM, like other antiepileptic drugs, is influenced by demand and the willingness to pay. As more competitors enter the market and patents expire, prices are expected to decline.

5. What are the future growth prospects for APTIOM in the antiepileptic drugs market? The antiepileptic drugs market, including APTIOM, is expected to grow significantly over the next few years, driven by increasing prevalence of neurological disorders and expanding distribution channels.

Sources

1. IndustryARC: Antiepileptic Drugs Market Size Report, 2024-2030.
2. BioSpace: Aptevo Therapeutics Reports 1Q 2024 Financial Results and Provides a Business Update.
3. AJMC: The Price of Progress: Understanding Innovation and Affordability of Prescription Drugs.
4. Clinical Trials Arena: Aptiom (eslicarbazepine acetate) for the Treatment of Partial-Onset Seizures.
5. Sumitomo Pharma: Conference on Q1 FY2024 Financial Results.

Last updated: 2024-12-16