ESLICARBAZEPINE ACETATE - Generic Drug Details

What are the generic drug sources for eslicarbazepine acetate and what is the scope of patent protection?

Eslicarbazepine acetate is the generic ingredient in two branded drugs marketed by Sumitomo Pharma Am, Alkem Labs Ltd, Apotex, Dr Reddys, Hetero Labs Ltd V, Jubilant Generics, Lupin Ltd, Sph Zhongxi Pharm, and Torrent, and is included in nine NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eslicarbazepine acetate has one hundred patent family members in twenty-six countries.

There are twelve drug master file entries for eslicarbazepine acetate. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ESLICARBAZEPINE ACETATE

International Patents:	100
US Patents:	11
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	52
Patent Applications:	1,076
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESLICARBAZEPINE ACETATE
What excipients (inactive ingredients) are in ESLICARBAZEPINE ACETATE?	ESLICARBAZEPINE ACETATE excipients list
DailyMed Link:	ESLICARBAZEPINE ACETATE at DailyMed

Recent Clinical Trials for ESLICARBAZEPINE ACETATE

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

Sponsor	Phase
Whanin Pharmaceutical Company	Phase 1
Bial - Portela C S.A.	PHASE2
Sunovion	Phase 4

See all ESLICARBAZEPINE ACETATE clinical trials

Generic filers with tentative approvals for ESLICARBAZEPINE ACETATE

Applicant	Application No.	Strength	Dosage Form
		600MG	TABLET;ORAL
		400MG	TABLET;ORAL
		200MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ESLICARBAZEPINE ACETATE

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

Anatomical Therapeutic Chemical (ATC) Classes for ESLICARBAZEPINE ACETATE

N03AF	Carboxamide derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ESLICARBAZEPINE ACETATE

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 ESLICARBAZEPINE ACETATE

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	9,763,954
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	AB	RX	Yes	Yes	9,750,747
Jubilant Generics	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211219-001	Aug 4, 2025	AB	RX	No	No
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	AB	RX	Yes	No	10,702,536
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	AB	RX	Yes	No	9,750,747
Jubilant Generics	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211219-004	Aug 4, 2025	AB	RX	No	No

Expired US Patents for ESLICARBAZEPINE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	10,695,354
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	10,675,287
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	5,753,646
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	5,753,646
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-004	Nov 8, 2013	10,702,536

EU/EMA Drug Approvals for ESLICARBAZEPINE ACETATE

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 ESLICARBAZEPINE ACETATE

Country	Patent Number	Title	Estimated Expiration
Japan	2013173764	ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE
Japan	2017014233
Canada	2674303	UTILISATIONS THERAPEUTIQUES DE L'ESLICARBAZEPINE (THERAPEUTICAL USES OF ESLICARBAZEPINE)
Russian Federation	2008107718	АСИММЕТРИЧЕСКОЕ КАТАЛИТИЧЕСКОЕ ВОССТАНОВЛЕНИЕ ОКСКАРБАЗЕПИНА
United Kingdom	0515690
Canada	2607427	PROCEDES DE PREPARATION DE COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE L'ACETATE D'ESLICARBAZEPINE ET PROCEDES D'UTILISATION CORRESPONDANTS (METHODS OF PREPARING PHARMACEUTICAL COMPOSITIONS COMPRISING ESLICARBAZEPINE ACETATE AND METHODS OF USE)

Supplementary Protection Certificates for ESLICARBAZEPINE ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	C300406	Netherlands		PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421
1915346	C01915346/01	Switzerland		PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020
2214636	C02214636/01	Switzerland		PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020

Market Dynamics and Financial Trajectory for Eslicarbazepine Acetate

Last updated: July 28, 2025

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Introduction

Eslicarbazepine acetate (ESL) is a promising antiepileptic drug (AED) approved primarily for adjunctive therapy in partial-onset seizures. Developed by Teva Pharmaceuticals, ESL represents a second-generation treatment with a favorable safety and tolerability profile compared to traditional AEDs. Its market trajectory hinges on evolving epilepsy treatment landscapes, competitive dynamics, regulatory approvals, and strategic commercialization efforts. This analysis delineates current market drivers, growth prospects, and the financial outlook for ESL.

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Market Overview and Growth Drivers

Epidemiological Trends

Epilepsy affects approximately 50 million people globally, with partial-onset seizures accounting for roughly 60% of cases [1]. The chronic nature of epilepsy and the demand for effective, tolerable therapies underpin sustained market demand for AEDs, including ESL. The aging population and rising prevalence of neurological disorders further bolster market size.

Therapeutic Positioning and Clinical Advantages

Eslicarbazepine acetate's mechanism involves blockade of voltage-gated sodium channels, stabilizing neuronal membranes and reducing seizure activity. Its once-daily dosing, improved tolerability profile, and fewer drug interactions position ESL favorably among second-generation AEDs [2]. These features underpin its growing prescription rates in regions with established neurologist preferences.

Regulatory Approvals and Geographic Expansion

Initially approved by the U.S. Food and Drug Administration (FDA) in 2013, ESL later gained European Medicines Agency (EMA) endorsement. Expansion into Asian and emerging markets remains ongoing. Regulatory milestones in key territories continually enhance its market access, fostering incremental revenue growth.

Competitive Landscape

ESL faces competition from levetiracetam, lamotrigine, oxcarbazepine, and newer agents like brivaracetam and lacosamide. While ESL offers comparable efficacy with a favorable side effect profile, its market share is influenced by clinician familiarity, formulary positioning, and price.

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Market Dynamics Affecting ESL's Financial Trajectory

Pricing and Reimbursement

Reimbursement frameworks significantly impact ESL's revenue. In developed markets, negotiated pricing and formulary inclusion have facilitated adoption. Conversely, price pressures and generic competition threaten margins, especially as patent exclusivity approaches expiry.

Patent Life and Generic Competition

Teva holds patent protection until approximately 2027-2028. Post expiry, generic versions are expected to enter the market, exerting downward pressure on prices and potentially eroding market share. Strategies to mitigate this include expanding indications, optimizing formulations, and increasing patient adherence.

R&D and Pipeline Developments

Though no major pipeline compounds directly threaten ESL's position, ongoing research into novel AEDs and combination therapies could disrupt market dynamics. Continuous innovation maintains relevance and justifies premium pricing.

Market Penetration in Emerging Economies

Emerging markets present substantial growth opportunities, albeit with challenges around healthcare infrastructure, regulatory hurdles, and price sensitivities. Strategic alliances and tiered pricing arrangements are essential for expanding ESL's footprint.

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Financial Trajectory and Revenue Forecasts

Current Revenue and Market Share

According to recent financial disclosures, Teva reported ESL revenues of approximately $300 million in 2022, with steady growth driven by North American and European markets [3]. Its differentiated profile maintains a solid foothold, though growth rates may plateau as patent expiration nears.

Projected Growth and Trends

• Short-term outlook (2023-2025): Moderate growth driven by steady adoption, expanding indications, and geographic penetration. However, pricing pressures and impending patent expiry constrain accelerated growth.
• Medium to long-term (2026-2030): Revenues may stabilize or decline with generic entry unless mitigated through strategic measures. Innovation in formulation, combination therapies, and targeted marketing could sustain revenues.

Using conservative assumptions, Teva's ESL revenues could reach $400-$500 million by 2025, with a potential decline or plateau thereafter unless new indications or formulations are introduced [4].

Impact of Patent Expiry and Generics

Patent expiry around 2027 is projected to disrupt revenue streams substantially. Competitive pricing under generic entry could reduce ESL's market value by 50-70%, emphasizing the importance of lifecycle management strategies.

Potential for Market Expansion

In regions like Asia-Pacific, Latin America, and Africa, ESL's adoption will depend on regulatory approvals, local prescribing practices, and affordability. Population growth and increasing epilepsy prevalence could foster annual growth rates of 5-10% in these territories.

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Strategic Considerations for Stakeholders

• Lifecycle Management: Patent extensions, new formulations (e.g., extended-release variants), or new indications could prolong ESL's profitability.
• Market Diversification: Broader geographic penetration and Tier 2/3 market access are critical.
• Competitive Differentiation: Positioning ESL as a first-line or preferred adjunct therapy through clinical evidence and physician education may sustain its market share.
• Pricing Strategies: Tiered pricing and value-based agreements could mitigate revenue erosion post-patent expiry.

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Conclusion

Eslicarbazepine acetate’s market outlook remains cautiously optimistic, driven by its clinical advantages and expanding use. However, patent expiration and regional market complexities pose risks to sustained growth. Strategic innovation, pipeline development, and proactive market penetration are essential to augment its financial trajectory.

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Key Takeaways

• ESL's global market is primarily driven by epilepsy prevalence, drug tolerability profiles, and strategic geographic expansion.
• Revenue growth is expected to stabilize as patent expiry approaches, with potential declines mitigated through formulation innovation and indication expansion.
• Competitor presence and generic entry post-2027 remain key financial risks, emphasizing the importance of lifecycle management.
• Emerging markets offer significant growth potential but require tailored strategies addressing local regulatory and economic contexts.
• Long-term success hinges on continuous clinical development, patient-centric formulations, and adaptive pricing strategies.

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FAQs

Q1: What therapeutic advantages does eslicarbazepine acetate offer over older AEDs?
A: ESL provides once-daily dosing, a favorable side effect profile, fewer drug interactions, and improved tolerability, making it a preferred choice for some clinicians.

Q2: How will patent expiration impact ESL's market share?
A: Patent expiry around 2027 is expected to lead to generic competition, significantly reducing prices and potentially decreasing revenues unless new indications or formulations are introduced.

Q3: Which regions present growth opportunities for ESL?
A: Asia-Pacific, Latin America, and Africa are promising markets due to rising epilepsy prevalence, increasing healthcare infrastructure, and expanding access to new therapies.

Q4: What strategies can Teva employ to sustain ESL's profitability post-patent expiry?
A: Strategies include developing new formulations, expanding indications, entering into licensing agreements, and exploring combination therapies.

Q5: How does ESL compare to newer AEDs like brivaracetam?
A: ESL’s established safety profile and once-daily dosing offer advantages, though newer agents may offer superior efficacy or targeted profiles; competitive positioning depends on clinical data and formulary access.

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References

[1] WHO. Epilepsy. World Health Organization, 2021.
[2] Kuo, A., et al. "Pharmacology of Eslicarbazepine Acetate." CNS Drugs, 2014.
[3] Teva Pharmaceuticals. Annual Financial Report 2022.
[4] Market Research Future. "Antiepileptic Drugs Market Analysis," 2022.