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KEPPRA Drug Profile

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Which patents cover Keppra, 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 three Paragraph IV challenges.

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. Ninety-four suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

Summary for KEPPRA

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	4
Suppliers / Packagers:	5
Bulk Api Vendors:	96
Clinical Trials:	64
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	KEPPRA at DailyMed

Pharmacology for KEPPRA

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for KEPPRA

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;IV (INFUSION)	021872-001	Jul 31, 2006	AP	RX	Yes	Yes
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-001	Sep 12, 2008	AB	RX	Yes	No			Y
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-001	Nov 30, 1999	AB	RX	Yes	No					Y
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-002	Feb 12, 2009	AB	RX	Yes	Yes			Y

Expired US Patents for KEPPRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505-001	Jul 15, 2003
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-004	Jan 6, 2006
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-001	Nov 30, 1999
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;IV (INFUSION)	021872-001	Jul 31, 2006

Paragraph IV (Patent) Challenges for KEPPRA

Drugname	Dosage	Strength	RLD	Submissiondate
	Extended-release Tablet	500 mg and 750 mg		2011-01-07
	Tablets	1000 mg		2007-01-24
	Extended-release Tablets	1000 mg		2011-01-07

International Patents for KEPPRA

Country	Document Number	Estimated Expiration
South Africa	200703096
New Zealand	554157
Spain	2524771
Croatia	P20141185

Supplementary Protection Certificates for KEPPRA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00028	Netherlands		PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
00C/032	Belgium		PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329