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Serving leading biopharmaceutical companies globally:

Colorcon
Daiichi Sankyo
Accenture
Healthtrust
Farmers Insurance
Moodys
Merck
Cantor Fitzgerald
US Army
Teva

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022285

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NDA 022285 describes KEPPRA XR, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the KEPPRA XR profile page.

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

Summary for 022285

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 022285

Suppliers and Packaging for NDA: 022285

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KEPPRA XR levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285 NDA UCB, Inc. 50474-598 50474-598-66 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-598-66)
KEPPRA XR levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285 NDA UCB, Inc. 50474-599 50474-599-66 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-599-66)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Sep 12, 2008TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Sep 17, 2028Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Feb 12, 2009TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Sep 17, 2028Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022285

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb IncKEPPRA XRlevetiracetamTABLET, EXTENDED RELEASE;ORAL022285-001Sep 12, 2008► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

UBS
Novartis
Dow
QuintilesIMS
Fish and Richardson
Colorcon
Cipla
Boehringer Ingelheim
Mallinckrodt
Federal Trade Commission

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