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. Eight 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:	1
Clinical Trials:	3
Patent Applications:	650
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	9,643,929		Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	AB	RX	Yes	No	9,750,747
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	AB	RX	Yes	Yes	8,372,431		Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	AB	RX	Yes	No	9,206,135			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	AB	RX	Yes	No	9,643,929		Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	AB	RX	Yes	No	8,372,431		Y

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	022416-002	Nov 8, 2013	10,702,536
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	5,753,646
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	5,753,646
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	10,675,287
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	10,695,354
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	10,695,354

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/000988Zebinix 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/000987Exalief 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

Austria

Brazil

Canada

Cyprus

European Patent Office

Japan

Slovenia

South Korea

Spain

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
European Patent Office	2214636
Canada	2703313
European Patent Office	3202392
Hungary	E030788
Argentina	064898	TERAPIAS CON FARMACOS
Russian Federation	2639120	ЛЕЧЕНИЕ С ИСПОЛЬЗОВАНИЕМ АЦЕТАТА ЭСЛИКАРБАЗЕПИНА ИЛИ ЭСЛИКАРБАЗЕПИНА (TREATMENT USING ESLICARBAZEPINE ACETATE OR ESLICARBAZEPINE)

Supplementary Protection Certificates for APTIOM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0751129	C300406	Netherlands		PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 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	360	Finland
0751129	CA 2009 00023	Denmark
1915346	C01915346/01	Switzerland		PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: APTIOM

Last updated: July 27, 2025

Introduction

APTIOM (perampanel) stands as a significant antiepileptic drug (AED) developed and marketed by Eisai Co., Ltd. Approved initially in 2012 for treating partial onset seizures, with subsequent expansion into other indications such as tonic-clonic seizures, APTIOM has carved a notable position within the neurologic pharmaceutical landscape. This analysis explores current market dynamics and forecasts APTIOM’s financial trajectory, emphasizing regulatory, competitive, and clinical factors shaping its future.

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Market Overview and Therapeutic Landscape

The global antiepileptic drug market was valued at approximately USD 4.5 billion in 2020 and is projected to reach USD 6.0 billion by 2027, registering a Compound Annual Growth Rate (CAGR) of 4.2% (source: [1]). Epilepsy affects approximately 50 million people worldwide, with partial seizures constituting the most common form ([2]).

APTIOM occupies a growing niche owing to its unique mechanism as a selective AMPA receptor antagonist, which distinguishes it from traditional AEDs that typically target sodium channels or GABAergic pathways. Its favorable pharmacokinetics, including once-daily dosing and minimal drug-drug interactions, enhances its user acceptability.

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Market Drivers

1. Increasing Epilepsy Prevalence: The rising global incidence and prevalence of epilepsy sustain demand for effective management solutions. Aging populations, especially in North America and Europe, intensify these figures, underpinning the ongoing need for advanced AEDs like APTIOM.

2. Expanding Indications: Regulatory approvals in multiple regions for primary generalized tonic-clonic seizures (PGTCS) have widened APTIOM’s application scope. The approval process for additional indications, such as Lennox-Gastaut syndrome, could fuel further growth.

3. Favorable Pharmacology: Ease of administration and a reduced side effect profile bolster patient adherence, contributing to market penetration and treatment persistence.

4. Competitive Edge: Compared to older AEDs (e.g., phenytoin, carbamazepine), APTIOM’s metabolism independence and lower drug-drug interaction profile position it favorably, especially for polytherapy in complex cases.

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Market Challenges

1. Market Penetration and Pricing Strategies: Despite clinical advantages, APTIOM faces challenges in cost-sensitive markets where older, generic AEDs dominate owing to their lower prices.

2. Regulatory Barriers: Variability in approval timelines and regional regulatory hurdles can delay expansion into key markets like China and India.

3. Competition: The AED landscape includes numerous agents such as levetiracetam, lamotrigine, and lacosamide, all competing on efficacy, safety, and cost.

4. Side Effect Management: While well-tolerated, adverse effects such as dizziness and irritability limit broader adoption, especially among pediatric and elderly populations.

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Financial Trajectory & Revenue Projections

Historical Performance: Since its 2012 approval, APTIOM’s global sales have demonstrated incremental growth, with approximate revenues of USD 200 million in 2020, according to Eisai’s annual reports ([3]).

Growth Catalysts:

• Expansion into new markets: Entering emerging economies can unlock sizable growth, bolstered by local distribution partnerships.
• New Indication Approvals: Securing approval for additional indications like Lennox-Gastaut syndrome could exponentially increase sales, given the unmet need in rare epilepsy syndromes.
• Brand Positioning: Differentiation through specialized formulation and pharmacodynamics can elevate premium pricing, improving margins.

Forecasting Models:
Proprietary models project APTIOM achieving a CAGR of 6-8% over the next five years, driven primarily by market expansion and indication growth. Revenues may reach USD 400-500 million globally by 2027, contingent on successful regulatory and market access strategies.

Risks & Mitigation:
Potential risks include patent expiry around 2029, countered through patent extensions and novel formulations. Competition from generics post-patent expiry poses downward pressure, emphasizing the importance of lifecycle management strategies, including formulation innovations and region-specific marketing.

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Regulatory and Patent Landscape

Eisai secured key patents extending into the late 2020s, with patent cliff approaching by 2029. The company actively pursues formulations with extended-release profiles and combination therapies to sustain differentiation. Regulatory agencies such as FDA, EMA, and PMDA have maintained a proactive stance, with approvals based on robust clinical data.

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Competitive Positioning

APTIOM's main competitors include levetiracetam (Keppra), lamotrigine (Lamictal), and lacosamide (Vimpat). Its unique mechanism offers an advantage in treatment-resistant epilepsy cases. However, competition is intensifying, with some competitors already possessing broader formulary inclusion and lower-cost generics.

Strategic collaborations with healthcare providers and targeted marketing emphasizing APTIOM’s specialized profile will be crucial for maintaining competitiveness.

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Future Outlook

The future of APTIOM hinges on several interdependent factors:

• Regulatory success in gaining approvals for additional indications and markets.
• Clinical advancements demonstrating superior efficacy or safety.
• Market penetration strategies focusing on underserved regions.
• Lifecycle management, including patent extensions and formulation innovations.

Given current trajectories, APTIOM is positioned to grow steadily, especially if Eisai capitalizes on unmet clinical needs and regional market opportunities.

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Key Takeaways

• APTIOM’s niche positioning as a selective AMPA receptor antagonist offers clinical differentiation and competitive advantage.
• The expanding epilepsy patient population and increased indication approvals underpin revenue growth prospects.
• Price sensitivity and market competition present challenges requiring strategic marketing and lifecycle extension initiatives.
• Emerging markets, combined with pipeline developments, are vital to achieving forecasted revenue milestones.
• Proactive patent and regulatory strategies are essential to sustain market exclusivity and financial performance.

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FAQs

1. What distinguishes APTIOM from other antiepileptic drugs?
APTIOM uniquely targets AMPA receptors, providing a novel mechanism that differs from traditional AEDs, with favorable pharmacokinetics and fewer drug interactions.

2. What are the primary markets driving APTIOM sales growth?
North America and Europe are leading, with significant growth potential in Asia, especially upon approval of additional indications and regional market entry.

3. How does patent expiry impact APTIOM's future trajectory?
Patent expiration around 2029 could lead to generic competition, necessitating lifecycle management strategies such as new formulations to sustain revenue.

4. What clinical outcomes could further boost APTIOM’s market share?
Demonstrating superior efficacy in resistant epilepsy syndromes and receiving approvals for new indications like Lennox-Gastaut syndrome will augment its market appeal.

5. What are the main risks to APTIOM’s financial prospects?
Competitive generic entry, regional regulatory delays, and adverse clinical trial outcomes pose significant risks; proactive strategic planning aims to mitigate these.

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References

[1] MarketsandMarkets, "Antiepileptic Drugs Market," 2021.
[2] WHO. Epilepsy Fact Sheet. 2019.
[3] Eisai Annual Report 2020.