KEPPRA Drug Patent Profile

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When do Keppra patents expire, and when can generic versions of Keppra launch?

Keppra is a drug marketed by Ucb Inc and is included in four NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Keppra

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

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Summary for KEPPRA

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	116
Patent Applications:	3,215
Drug Prices:	Drug price information for KEPPRA
Drug Sales Revenues:	Drug sales revenues for KEPPRA
What excipients (inactive ingredients) are in KEPPRA?	KEPPRA excipients list
DailyMed Link:	KEPPRA at DailyMed

Drug patent expirations by year for KEPPRA

Recent Clinical Trials for KEPPRA

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

Sponsor	Phase
Sohag University	Phase 2
Myrtelle Inc.	Phase 1/Phase 2
CureRareDisease LLC	Phase 1/Phase 2

See all KEPPRA clinical trials

Pharmacology for KEPPRA

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for KEPPRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KEPPRA	Tablets	levetiracetam	1000 mg	021035	1	2007-01-24

US Patents and Regulatory Information for KEPPRA

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-001	Sep 12, 2008	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-001	Nov 30, 1999	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-002	Feb 12, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505-001	Jul 15, 2003	AA	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-004	Jan 6, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-003	Nov 30, 1999	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for KEPPRA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006	⤷ Sign Up	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-004	Jan 6, 2006	⤷ Sign Up	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-001	Nov 30, 1999	⤷ Sign Up	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-002	Nov 30, 1999	⤷ Sign Up	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-002	Nov 30, 1999	⤷ Sign Up	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-003	Nov 30, 1999	⤷ Sign Up	⤷ Sign Up
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-003	Nov 30, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for KEPPRA

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for KEPPRA

See the table below for patents covering KEPPRA around the world.

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Country	Patent Number	Title	Estimated Expiration
Slovenia	1909764		⤷ Sign Up
Japan	2013018786	PHARMACEUTICAL COMPOSITION CONTAINING LEVETIRACETAM AND PREPARATION METHOD THEREFOR	⤷ Sign Up
South Korea	20080030546	PHARMACEUTICAL COMPOSITIONS COMPRISING LEVETIRACETAM AND PROCESS FOR THEIR PREPARATION	⤷ Sign Up
Taiwan	200738280	Novel pharmaceutical compositions comprising levetiracetam and process for their preparation	⤷ Sign Up
Bulgaria	60030	METHOD FOR THE PREPARATION OF /D/-ETHYL-2-OXO-1-PIRROLIDINEACETAMIDE	⤷ Sign Up
Denmark	1909764		⤷ Sign Up
Croatia	P20141185		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for KEPPRA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0162036	2000C/032	Belgium	⤷ Sign Up	PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
0162036	C300028	Netherlands	⤷ Sign Up	PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
0162036	SPC/GB00/030	United Kingdom	⤷ Sign Up	SPC/GB00/030: 20050514, EXPIRES: 20100514
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description