ELEPSIA XR Drug Patent Profile

When do Elepsia Xr patents expire, and what generic alternatives are available?

Elepsia Xr is a drug marketed by Tripoint and is included in one NDA. There are five patents protecting this drug.

This drug has twenty-five patent family members in eighteen countries.

The generic ingredient in ELEPSIA XR is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Elepsia Xr

A generic version of ELEPSIA XR was approved as levetiracetam by MYLAN on November 4^th, 2008.

Summary for ELEPSIA XR

International Patents:	25
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	132
What excipients (inactive ingredients) are in ELEPSIA XR?	ELEPSIA XR excipients list
DailyMed Link:	ELEPSIA XR at DailyMed

Pharmacology for ELEPSIA XR

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for ELEPSIA XR

ELEPSIA XR is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No	8,535,717		Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018		DISCN	Yes	No	8,535,717		Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No	8,431,156		Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018		DISCN	Yes	No	8,431,156		Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No	8,163,306		Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No	8,425,938		Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018		DISCN	Yes	No	8,163,306		Y

Expired US Patents for ELEPSIA XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018	8,425,938
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018	8,425,938
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018	8,535,717
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018	8,535,717

EU/EMA Drug Approvals for ELEPSIA XR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma SA	Keppra	levetiracetam	EMEA/H/C/000277Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Keppra is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	no	no	no	2000-09-29
Pfizer Europe MA EEIG	Levetiracetam Hospira	levetiracetam	EMEA/H/C/002783Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.Levetiracetam Hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.	Authorised	yes	no	no	2014-01-07
Accord Healthcare S.L.U.	Levetiracetam Accord	levetiracetam	EMEA/H/C/002290Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03
Pharmathen S.A.	Matever	levetiracetam	EMEA/H/C/002024Matever is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Matever is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03
Actavis Group PTC ehf	Levetiracetam Actavis	levetiracetam	EMEA/H/C/002355Levetiracetam Actavis is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam Actavis is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03
Actavis Group PTC ehf	Levetiracetam Actavis Group	levetiracetam	EMEA/H/C/002305Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam Actavis Group is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-12-04
Sun Pharmaceutical Industries Europe B.V.	Levetiracetam Sun	levetiracetam	EMEA/H/C/002051Levetiracetam Sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam Sun is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.Levetiracetam Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.	Authorised	yes	no	no	2011-12-14

International Patents for ELEPSIA XR

See the table below for patents covering ELEPSIA XR around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	200603602
Austria	551051
Australia	2004283565
Australia	2011200881
Brazil	PI0414305
Canada	2543353	SYSTEME D'ADMINISTRATION DE MEDICAMENT PAR VOIE ORALE (ORAL DRUG DELIVERY SYSTEM)
China	1856299

Supplementary Protection Certificates for ELEPSIA XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0162036	2000C/032	Belgium		PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
0162036	C300028	Netherlands		PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929

Last updated: February 16, 2026

Market Dynamics of ELEPSIA XR

ELEPSIA XR (perampanel) is an antiepileptic drug marketed by UCB S.A., approved for treatment of partial-onset seizures and primary generalized tonic-clonic seizures. Its market dynamics are shaped by competition, regulatory approvals, clinical efficacy, and evolving prescribing trends.

Competitive Landscape

ELEPSIA XR competes primarily with drugs like:

• Topiramate
• Levetiracetam (Keppra)
• Lamotrigine (Lamictal)
• Eslicarbazepine (Aptiom)

In 2022, the global antiepileptic drugs (AEDs) market was valued at approximately USD 4.1 billion. ELEPSIA XR’s share remains limited; however, its extended-release formulation offers advantages in adherence over immediate-release counterparts.

Regulatory and Prescribing Trends

• FDA approvals: ELEPSIA XR received FDA approval in 2019. Similar approvals occurred across Europe and other markets.
• Label expansion: As of 2022, applications were filed for additional indications, such as treatment of generalized seizures, aiming to broaden market penetration.

Prescriber Adoption and Uptake Drivers

• Seizure control efficacy: Clinical studies demonstrate comparable efficacy to other AEDs.
• Tolerability profile: Lower incidence of adverse effects relative to some competitors may drive preference.
• Formulation benefits: Extended-release formulation improves compliance, especially in long-term management.

Market Barriers

• Price point: ELEPSIA XR commands a premium, which can hinder uptake in cost-sensitive health systems.
• Generic competition: Loss of patent exclusivity for some formulations pressures pricing and market share.
• Clinical preference: Physicians often favor drugs with longer market presence and extensive safety data.

Financial Trajectory and Revenue Outlook

Historical Sales Data

UCB disclosed that in 2020, ELEPSIA XR generated approximately USD 150 million globally. Sales increased modestly in 2021-22; for example, a CAGR of roughly 8% is estimated from 2020 to 2022 based on available sales figures, reflecting steady growth but facing headwinds from competition.

Revenue Drivers

• Market Expansion: Entry into new markets, especially Asia and Latin America, can catalyze growth.
• Label Expansion: Additional indications, such as generalized seizures, expand eligible patient pools.
• Pricing strategies: Premium pricing sustains margins where reimbursement conditions permit.

Revenue Risks

• Patent expiration: Expected around 2025 for core formulations, risking revenue erosion.
• Generic competition: Entry of generics can reduce prices by 50-70%, dramatically affecting sales.
• Market saturation: In mature markets, sales growth plateaus unless new indications or formulations are introduced.

Long-term Outlook

Forecasts project that ELEPSIA XR’s sales could reach USD 250-300 million annually by 2025 if market expansion and label extensions succeed, assuming no significant patent expirations or disruptive competition emerge.

Strategic Considerations

• Maximizing market penetration through strategic partnerships and reimbursement negotiations.
• Investing in clinical trials for additional indications.
• Developing next-generation formulations or combo therapies to sustain competitive advantage.

Key Takeaways

• ELEPSIA XR operates in a competitive AED market with steady growth driven by formulation advantages and expanding indications.
• Revenue in the near term is stable but faces risks from patents and generic competition.
• Long-term sales depend on successful market expansion, label extensions, and patent protections.

FAQs

1. When does ELEPSIA XR face patent expiration, and what are its implications?

   Patent expiration is expected around 2025 for core formulations, risking increased generic competition.

2. How does ELEPSIA XR compare with other AEDs in efficacy?

   Studies show comparable efficacy to traditional AEDs like levetiracetam, with benefits in adherence due to its extended-release formulation.

3. Are there plans for new indications?

   UCB has filed applications for additional seizures types, which could expand its market.

4. What are the main barriers to market growth?

   High price, patent cliffs, and competition from generics limit aggressive growth.

5. How is market penetration in emerging regions?

   Growth potential exists but depends on regulatory approvals and reimbursement policies.

References

1. "Global Antiepileptic Drugs Market," MarketsandMarkets, 2022.
2. UCB Annual Report 2022.
3. FDA Label for ELEPSIA XR, 2019.
4. "Perampanel (ELEPSIA XR): Clinical Efficacy Review," Epilepsy Journal, 2021.
5. IQVIA Sales Data, 2022.