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Serving leading biopharmaceutical companies globally:

Merck
Chubb
Healthtrust
QuintilesIMS
Boehringer Ingelheim
Cantor Fitzgerald
Fish and Richardson
McKinsey
Citi
Teva

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021035

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NDA 021035 describes KEPPRA, which is a drug marketed by Ucb Inc and is included in four NDAs. It is available from seven suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the KEPPRA profile page.

The generic ingredient in KEPPRA is levetiracetam. There are thirty-five drug master file entries for this compound. Ninety-nine suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 021035
Tradename:KEPPRA
Applicant:Ucb Inc
Ingredient:levetiracetam
Patents:1
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 021035
Suppliers and Packaging for NDA: 021035
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KEPPRA levetiracetam TABLET;ORAL 021035 NDA STAT RX USA LLC 16590-134 16590-134-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-134-30)
KEPPRA levetiracetam TABLET;ORAL 021035 NDA STAT RX USA LLC 16590-135 16590-135-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-135-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Nov 30, 1999TE:ABRLD:Yes
Patent:➤ SubscribePatent Expiration:Dec 7, 2031Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Nov 30, 1999TE:ABRLD:Yes
Patent:➤ SubscribePatent Expiration:Dec 7, 2031Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Nov 30, 1999TE:ABRLD:Yes
Patent:➤ SubscribePatent Expiration:Dec 7, 2031Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021035

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-004 Jan 6, 2006 ➤ Subscribe ➤ Subscribe
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 ➤ Subscribe ➤ Subscribe
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-002 Nov 30, 1999 ➤ Subscribe ➤ Subscribe
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 ➤ Subscribe ➤ Subscribe
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999 ➤ Subscribe ➤ Subscribe
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999 ➤ Subscribe ➤ Subscribe
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-002 Nov 30, 1999 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Accenture
Healthtrust
Colorcon
Covington
Boehringer Ingelheim
Cantor Fitzgerald
Cerilliant
Harvard Business School
Fuji

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