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:	3,249
Formulation / Manufacturing:	see details
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

Anatomical Therapeutic Chemical (ATC) Classes for ELEPSIA XR

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for ELEPSIA XR

ELEPSIA XR is protected by five US patents.

Patents protecting ELEPSIA XR

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

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

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
Denmark	1663175
Japan	2015038126	経口薬送達システム (ORAL DRUG DELIVERY SYSTEM)
European Patent Office	1663175	SYSTEME D'ADMINISTRATION DE MEDICAMENT PAR VOIE ORALE (ORAL DRUG DELIVERY SYSTEM)
Poland	381756

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