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-six 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:	2
Raw Ingredient (Bulk) Api Vendors:	132
Patent Applications:	3,497
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			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018		DISCN	Yes	No			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018		DISCN	Yes	No			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018		DISCN	Yes	No			Y

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/000277 Keppra 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/002783 Levetiracetam 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/002290 Levetiracetam 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/002024 Matever 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/002355 Levetiracetam 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/002305 Levetiracetam 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/002051 Levetiracetam 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
European Patent Office	1663175	SYSTEME D'ADMINISTRATION DE MEDICAMENT PAR VOIE ORALE (ORAL DRUG DELIVERY SYSTEM)
Japan	5666075
Eurasian Patent Organization	013106	ОРАЛЬНАЯ СИСТЕМА ДОСТАВКИ ЛЕКАРСТВЕННОГО ПРЕПАРАТА (ВАРИАНТЫ) (ORAL DRUG DELIVERY SYSTEM)
Portugal	1663175
African Regional IP Organization (ARIPO)	200603602
Brazil	PI0414305
Japan	2015038126	経口薬送達システム (ORAL DRUG DELIVERY SYSTEM)

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

ELEPSIA XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ELEPSIA XR

Introduction to ELEPSIA XR

ELEPSIA XR is an extended-release formulation of levetiracetam, a medication used in the treatment of seizures, particularly partial-onset seizures. It is designed to provide a convenient once-daily dosing regimen, which can improve patient compliance and reduce the fluctuations in blood levels associated with immediate-release formulations.

Market Context

The global epilepsy drugs market is experiencing significant growth, driven by increasing prevalence of epilepsy, growing awareness of the disease, and the introduction of new-generation anti-epileptic medications. Here are some key market dynamics influencing ELEPSIA XR:

Increasing Prevalence of Epilepsy

The global epilepsy drugs market is driven by the rising prevalence of epilepsy. In the United States alone, 3 million people and 470,000 children have been diagnosed with epilepsy, according to the CDC[4].

Growing Awareness and Government Initiatives

The market is also propelled by growing public awareness of epilepsy and its treatment options. Strategic alliances between government authorities and healthcare providers are further enhancing the market outlook[4].

Competitive Landscape

ELEPSIA XR operates within a competitive landscape dominated by several major pharmaceutical companies. Key players in the refractory epilepsy market include Pfizer, Novartis, Abbott, Neurelis Inc, GSK Plc, and others[1].

Other Key Players and Products

Companies like Supernus Pharmaceuticals have also made significant contributions with products such as Oxtellar XR and Trokendi XR, which are extended-release formulations for epilepsy treatment. These products have shown strong market performance and have helped in expanding the company's neurology portfolio[3].

Financial Trajectory

Market Size and Growth

The refractory epilepsy market, which includes drugs like ELEPSIA XR, is estimated to grow at a CAGR of 4.2% from 2024 to 2031. The market is expected to be valued at USD 1.2 billion in 2024 and reach USD 3.1 billion by 2031[1].

Peak Sales Potential

ELEPSIA XR, as a near-term commercialization opportunity, has a peak sales potential of USD 50 million in the US market. This is indicative of the strong financial prospects for this drug, especially given its unique formulation and compliance benefits[2].

Regulatory and Commercialization Challenges

FDA Approvals and Manufacturing Issues

The commercialization of ELEPSIA XR has faced delays due to regulatory issues. For instance, Sun Pharma Advanced Research Company (SPARC), which in-licensed ELEPSIA XR, has encountered delays due to a warning letter from the US FDA regarding manufacturing compliance at their Halol plant. SPARC has initiated site transfers and resubmission of the new drug applications (NDAs) to address these issues[2].

Resubmission and Alternate Manufacturing Sites

SPARC is working on alternate manufacturing sites and resubmitting the applications to expedite the approval process. However, the company has not provided a concrete timeline for these efforts, indicating ongoing challenges in the commercialization process[2].

Product Differentiation and Compliance

Once-Daily Dosing Regimen

ELEPSIA XR offers a once-daily dosing regimen, which is a significant advantage in terms of patient compliance. This formulation avoids the blood level fluctuations associated with immediate-release products, leading to better therapeutic outcomes and reduced side effects[5].

Pharmacokinetic Profile

The unique pharmacokinetic profile of ELEPSIA XR ensures a smooth and steady release of the medication, which is crucial for maintaining consistent therapeutic levels and minimizing adverse reactions[5].

Adverse Reactions and Safety Considerations

Somnolence and Fatigue

ELEPSIA XR, like other levetiracetam formulations, may cause somnolence and fatigue. Clinical trials have shown that these adverse reactions are more common in patients receiving higher doses, and they can be serious in some cases[5].

Renal Impairment and Dose Adjustments

The drug is not recommended for patients with moderate or severe renal impairment. For patients with mild renal impairment, dose adjustments are necessary, and creatinine clearance must be calculated to determine the appropriate dose[5].

Key Takeaways

• Market Growth: The refractory epilepsy market, including ELEPSIA XR, is expected to grow at a CAGR of 4.2% from 2024 to 2031.
• Peak Sales Potential: ELEPSIA XR has a peak sales potential of USD 50 million in the US market.
• Regulatory Challenges: Commercialization has been delayed due to FDA compliance issues, but SPARC is working on resubmissions and alternate manufacturing sites.
• Product Differentiation: ELEPSIA XR offers a convenient once-daily dosing regimen with a unique pharmacokinetic profile.
• Safety Considerations: The drug may cause somnolence and fatigue, and dose adjustments are necessary for patients with renal impairment.

FAQs

1. What is the expected market size of the refractory epilepsy market by 2031?

   • The refractory epilepsy market is expected to reach USD 3.1 billion by 2031[1].

2. What is the peak sales potential of ELEPSIA XR in the US market?

   • ELEPSIA XR has a peak sales potential of USD 50 million in the US market[2].

3. Why has the commercialization of ELEPSIA XR been delayed?

   • The commercialization has been delayed due to FDA compliance issues at the manufacturing plant, prompting SPARC to initiate site transfers and resubmit the NDAs[2].

4. What are the key benefits of ELEPSIA XR's once-daily dosing regimen?

   • The once-daily dosing regimen improves patient compliance and avoids blood level fluctuations associated with immediate-release products, reducing side effects[5].

5. Are there any specific safety considerations for patients taking ELEPSIA XR?

   • Yes, patients should be aware of potential somnolence and fatigue, and dose adjustments are necessary for those with renal impairment[5].

Cited Sources

1. Coherent Market Insights: Refractory Epilepsy Market - Report, Trends, Share & Insights.
2. MoneyControl: SPARC may further face delays in commercializing new drugs Xelpros, Elepsia XR in US.
3. Supernus Pharmaceuticals Inc: SUPERNUS PHARMACEUTICALS INC.
4. Cognitive Market Research: Global Epilepsy Drugs Market Report 2024 Edition.
5. FDA: ELEPSIA XR Label.