Eslicarbazepine acetate - Generic Drug Details

What are the generic drug sources for eslicarbazepine acetate and what is the scope of freedom to operate?

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, Lupin Ltd, and Torrent, and is included in seven 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. Two 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:	7
NDAs:	7
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	51
Patent Applications:	433
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
Sunovion	Phase 4
Stanford University	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	022416-001	Nov 8, 2013	AB	RX	Yes	No	9,643,929		Y
Dr Reddys	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211238-003	Jun 29, 2021	AB	RX	No	No
Apotex	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211236-001	Dec 7, 2023		DISCN	No	No
Dr Reddys	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211238-001	Jun 29, 2021	AB	RX	No	No
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	AB	RX	Yes	No	10,912,781		Y

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	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	022416-003	Nov 8, 2013	5,753,646
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	5,753,646

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/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 eslicarbazepine acetate

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0520258
Japan	5295765
Japan	2010515727
Russian Federation	2546521	ЛЕКАРСТВЕННЫЕ ФОРМЫ ДЛЯ ПЕРОРАЛЬНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ АЦЕТАТ ЛИКАРБАЗЕПИНА (DOSAGE FORMS FOR ORAL APPLICATION CONTAINING LICARBAZEPINE ACETATE)
Poland	1915346

Supplementary Protection Certificates for eslicarbazepine acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0751129	C300406	Netherlands		PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 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	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

Eslicarbazepine acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Eslicarbazepine Acetate

Introduction to Eslicarbazepine Acetate

Eslicarbazepine acetate, commonly known by its brand name Aptiom, is a once-daily oral antiepileptic drug (AED) indicated for the treatment of partial-onset seizures (POS). It is rapidly and extensively metabolized to its active metabolite, eslicarbazepine, which acts primarily by stabilizing the inactivated state of voltage-gated sodium channels[5].

Market Size and Growth Projections

The global eslicarbazepine acetate reagent market has been experiencing significant growth. As of 2023, the market size was valued at USD 1.2 billion and is projected to reach USD 2.8 billion by 2032. This growth indicates a robust and expanding market for this drug[1].

Cost-Effectiveness and Economic Outcomes

Studies have shown that eslicarbazepine acetate is not only effective but also cost-efficient compared to other antiepileptic drugs. A retrospective analysis comparing the costs associated with eslicarbazepine acetate (ESL) and brivaracetam (BRV) among patients with focal seizures in long-term care in the US revealed that ESL initiation was associated with significant reductions in all-cause and epilepsy-specific pharmacy and total costs. Specifically, ESL resulted in 33.3% lower all-cause pharmacy costs, 34.4% lower epilepsy-specific pharmacy costs, 21.3% lower all-cause total costs, and 30.9% lower epilepsy-specific total costs compared to BRV[2].

Clinical Efficacy and Conversion Studies

Clinical studies have demonstrated the efficacy of eslicarbazepine acetate in converting patients from adjunctive therapy to monotherapy. Modeling and simulation studies have predicted that even at a lower dose of 800 mg, ESL can be an effective monotherapy option for patients who cannot tolerate higher doses. These studies used population pharmacokinetic models to predict plasma eslicarbazepine concentrations and the time to study exit, indicating that ESL monotherapy at 800 mg QD is a viable option for many patients[5].

Market Dynamics and Competitive Landscape

The market for antiepileptic drugs is highly competitive, with several players vying for market share. However, eslicarbazepine acetate has carved out a niche due to its once-daily dosing regimen and favorable pharmacokinetic profile. The positive momentum in market dynamics, coupled with the expected sustained expansion, points to robust growth rates for eslicarbazepine acetate in the forecasted period[4].

Pharmaceutical Industry Trends

The pharmaceutical industry is undergoing significant changes, with a shift towards biotechnology modalities and digital transformation. Companies like Sumitomo Pharma are focusing on accelerating digital transformation, including AI in drug discovery and digital innovation in R&D. This trend is expected to impact the development and marketing of drugs like eslicarbazepine acetate, potentially enhancing its market position through improved research and development processes[3].

Financial Performance and Revenue Projections

The financial performance of eslicarbazepine acetate is closely tied to its market size and growth projections. With a projected market size of USD 2.8 billion by 2032, the drug is expected to contribute significantly to the revenue of pharmaceutical companies involved in its production and distribution. The cost-effectiveness and clinical efficacy of eslicarbazepine acetate are key factors driving its financial success[1].

Strategic Alliances and Business Models

Pharmaceutical companies are increasingly forming strategic alliances to mitigate risks and invest in first-in-class drug discovery. For example, Sumitovant Biopharma's strategic alliance with Roivant has allowed it to acquire late-stage development assets, which can potentially include drugs like eslicarbazepine acetate. These alliances help in promoting the utilization of digital technology and accelerating operational reforms, further supporting the market trajectory of such drugs[3].

Regulatory and Access Considerations

Market access and regulatory approvals are crucial for the financial trajectory of any drug. Companies are actively engaging with payers to ensure rapid and broad access to eslicarbazepine acetate. This includes multi-channel marketing campaigns and co-promotion agreements to enhance the drug's visibility and prescribing rates among healthcare providers[3].

Patient and Healthcare Provider Engagement

Effective engagement with patients and healthcare providers is essential for the market success of eslicarbazepine acetate. Educational campaigns and clinical interactions are being used to build confidence among prescribers. For instance, over 10,000 total healthcare provider interactions have been reported since the launch of similar drugs, indicating a strong focus on educating and engaging the medical community[3].

Digital and Social Media Marketing

The use of digital and social media marketing is becoming increasingly important in the pharmaceutical industry. Companies are leveraging these channels to activate patients and promote drugs like eslicarbazepine acetate. This multi-channel approach helps in raising awareness, driving education, and advocating for patient needs, ultimately contributing to the drug's market dynamics and financial performance[3].

Conclusion

Eslicarbazepine acetate is positioned for significant growth in the antiepileptic drug market due to its clinical efficacy, cost-effectiveness, and favorable market dynamics. With a projected market size of USD 2.8 billion by 2032, the drug is expected to play a crucial role in the financial trajectories of pharmaceutical companies involved in its production and distribution.

Key Takeaways

• Market Growth: The global eslicarbazepine acetate reagent market is projected to reach USD 2.8 billion by 2032.
• Cost-Effectiveness: Eslicarbazepine acetate is associated with significant reductions in pharmacy and total costs compared to other antiepileptic drugs.
• Clinical Efficacy: The drug is effective in converting patients from adjunctive therapy to monotherapy, even at lower doses.
• Market Dynamics: The market is influenced by trends in biotechnology and digital transformation.
• Financial Performance: The drug's financial success is driven by its market size, cost-effectiveness, and clinical efficacy.

FAQs

Q: What is the projected market size of eslicarbazepine acetate by 2032? A: The global eslicarbazepine acetate reagent market is projected to reach USD 2.8 billion by 2032[1].

Q: How does eslicarbazepine acetate compare to other antiepileptic drugs in terms of cost? A: Eslicarbazepine acetate is associated with significant reductions in all-cause and epilepsy-specific pharmacy and total costs compared to brivaracetam[2].

Q: What is the clinical efficacy of eslicarbazepine acetate in converting patients to monotherapy? A: Eslicarbazepine acetate is effective in converting patients from adjunctive therapy to monotherapy, even at a lower dose of 800 mg QD[5].

Q: How is the pharmaceutical industry's shift towards biotechnology and digital transformation impacting eslicarbazepine acetate? A: The shift is expected to enhance the drug's market position through improved research and development processes and operational reforms[3].

Q: What strategies are companies using to promote eslicarbazepine acetate? A: Companies are using multi-channel marketing campaigns, co-promotion agreements, and engaging with payers to ensure rapid and broad access to the drug[3].

Sources

1. DataIntelo: Global Eslicarbazepine Acetate Reagent Market Research Report 2032.
2. PubMed: Comparative economic outcomes in patients with focal seizures...
3. Sumitomo Pharma: Sumitovant Meeting - Sumitomo Pharma.
4. Market Research Intellect: Global Eslicarbazepine Acetate API Market Size, Scope And Forecast Report.
5. DovePress: Prediction of efficacy for conversion from adjunctive therapy to monotherapy...