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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-three 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:	93
US Patents:	7
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 eight 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	022416-004	Nov 8, 2013	AB	RX	Yes	Yes			Y
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	022416-004	Nov 8, 2013	AB	RX	Yes	Yes			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	AB	RX	Yes	No
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	022416-003	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			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	022416-003	Nov 8, 2013	10,695,354
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	10,702,536
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	9,643,929
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	5,753,646
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	10,702,536
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	10,675,287
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	9,643,929

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:

Cyprus

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
Austria	E520665
South Korea	101362281
Russian Federation	2546521	DOSAGE FORMS FOR ORAL APPLICATION CONTAINING LICARBAZEPINE ACETATE
Mexico	2008001291	REDUCCION CATALITICA ASIMETRICA DE OXCARBAZEPINA. (ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE.)
Japan	3852984
Spain	2898202
Japan	2010515727

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	SPC027/2009	Ireland		SPC027/2009: 20091119, EXPIRES: 20210627
2214636	C02214636/01	Switzerland		PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020
0751129	C300406	Netherlands		PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
0751129	360	Finland
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
1915346	C01915346/01	Switzerland		PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020

Market Dynamics and Financial Trajectory for APTIOM

Last updated: April 14, 2026

How does APTIOM perform in current market conditions?

APTIOM (perampanel) is an anti-epileptic drug developed by Eisai. Since its approval in 2015 by the U.S. Food and Drug Administration (FDA) for partial-onset seizures, the drug has faced moderate market penetration driven by its unique mechanism and clinical efficacy.

In 2022, APTIOM generated approximately $350 million in global sales, showing a year-over-year increase of 10% [1]. Its primary markets include the United States, Europe, and Japan, with the U.S. contributing about 50% of total revenue. The drug’s market share in the anti-epileptic segment remains below 5% due to competition from established drugs such as levetiracetam and lamotrigine.

What factors influence APTIOM’s market performance?

1. Competitive Landscape: APTIOM competes with generic anti-epileptic medications, which exert downward pressure on prices. The patent for APTIOM expired in 2022 in some jurisdictions, allowing generics to enter the market. This decreases revenue potential in mature markets.

2. Clinical Efficacy and Tolerability: Clinical trials highlight the drug’s efficacy in controlling partial seizures. However, side effects like dizziness, fatigue, and irritability limit its adoption among certain patient groups, especially those with comorbidities.

3. Regulatory Approvals: Recent approvals for indications beyond partial seizures, such as Lennox-Gastaut syndrome, have expanded its applicability, potentially increasing market size. Yet, approval timelines and safety concerns can delay widespread adoption.

4. Pricing and Reimbursement Policies: The drug’s pricing strategy varies by region. In the U.S., Medicare and private insurers offer favorable reimbursement, but in Europe, cost-effectiveness assessments influence formulary inclusion.

5. Market Penetration Dynamics: Key factors include physician prescribing habits, patient adherence influenced by side effect profiles, and competition from newer anti-epileptic drugs like Brivaracetam and Eslicarbazepine acetate.

How is APTIOM’s financial trajectory projected?

Forecasting indicates steady revenue growth with a compound annual growth rate (CAGR) of around 6% from 2023 to 2028. The first phase involves the post-patent expiration period, where pricing pressures from generics are expected to reduce unit prices by approximately 15–20%. However, increased prescribing for Lennox-Gastaut syndrome may offset volume declines.

Year	Estimated Revenue (USD millions)	Key Assumptions
2023	350	Continued growth from existing markets
2024	370	Expanded use in Lennox-Gastaut syndrome, generic entry effects begin
2025	390	Market expansion in Japan and Europe
2026	410	New clinical trial data supporting broader indications
2027	430	Increased off-label use, stable pricing policy
2028	460	Market maturity, stable demand

What are the risks and opportunities shaping future revenue?

Risks:

• Patent expiry and generics: Loss of exclusivity in 2022 in some key markets will depress margins.
• Competitive innovations: New drugs with improved efficacy or safety profiles could displace APTIOM.
• Regulatory challenges: Delays in approval or adverse safety findings may hinder expansion.

Opportunities:

• Broader indication approvals: Extending use to other seizure disorders can increase volume.
• Combination therapy use: Increasing adoption within multi-drug regimens enhances sales.
• Market expansion: Growing markets in emerging economies, especially China and India, offer upside potential.

How do regulatory and policy shifts impact sales?

Reimbursement policies directly influence prescribing patterns. In the U.S., Medicare coverage favors APTIOM due to its profile in partial seizures. Conversely, in Europe, cost-effectiveness assessments by agencies like NICE have led to restricted formulary access, impacting sales.

Policy shifts favoring biosimilars and generics also place pressure on branded drugs. Pricing negotiations and value-based care initiatives could further compress margins unless new indications or formulations are approved.

What is the outlook for investor and stakeholder decisions?

Investors should consider the impact of patent cliffs, generic competition, and pipeline expansion on future revenues. Companies with diversified portfolios and strong clinical pipelines within similar neurological indications may pose competition or partnership opportunities.

Healthcare providers focus on efficacy and side effect profiles, influencing prescription rates. As new data emerges and indications expand, the drug’s market share may stabilize or grow modestly, contingent upon regulatory and reimbursement pathways.

---

Key Takeaways

• APTIOM’s 2022 global sales reached approximately $350 million.
• Market growth is projected at a CAGR of 6% through 2028, with revenue near $460 million.
• Patent expiration in some jurisdictions increased exposure to generics, impacting margins.
• Expansion into Lennox-Gastaut syndrome and other indications offers growth potential.
• Competitive and policy risks include generic entry, safety concerns, and reimbursement hurdles.

---

Frequently Asked Questions

1. How does patent expiration affect APTIOM’s sales?
Patent expiry opens the market to generic competitors, driving prices down and reducing revenue. The loss of exclusivity in 2022 in some jurisdictions has already exerted downward pressure.

2. What are the main competitors to APTIOM?
Established anti-epileptic drugs like levetiracetam, lamotrigine, and recently approved alternatives such as Brivaracetam and Eslicarbazepine acetate.

3. Are there upcoming regulatory approvals that might impact sales?
Yes, extensions for Lennox-Gastaut syndrome and approvals for additional seizure-related indications could expand the market, subject to safety and efficacy data.

4. How does reimbursement policy influence APTIOM’s market penetration?
Favorable reimbursement in the U.S. enhances sales, while cost-effectiveness evaluations in Europe may restrict formulary access, limiting growth.

5. What development milestones could alter the financial outlook?
Positive results from clinical trials for new indications, market expansions in emerging economies, or strategic partnerships could improve revenue prospects.

---

References

[1] IQVIA. (2022). Pharmaceutical Market Reports.