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Mallinckrodt
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Merck
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Healthtrust
QuintilesIMS
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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021400

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NDA 021400 describes LEVITRA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from six suppliers. There are four patents protecting this drug and three Paragraph IV challenges. Additional details are available on the LEVITRA profile page.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
Summary for 021400
Tradename:LEVITRA
Applicant:Bayer Hlthcare
Ingredient:vardenafil hydrochloride
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021400
Suppliers and Packaging for NDA: 021400
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVITRA vardenafil hydrochloride TABLET;ORAL 021400 NDA GlaxoSmithKline LLC 0173-0828 N 0173-0828-13
LEVITRA vardenafil hydrochloride TABLET;ORAL 021400 NDA GlaxoSmithKline LLC 0173-0829 N 0173-0829-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 19, 2003TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 31, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:ERECTILE DYSFUNCTION
Patent:➤ Try a Free TrialPatent Expiration:Oct 31, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:ERECTILE DYSFUNCTION
Patent:➤ Try a Free TrialPatent Expiration:Jul 23, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATEMENT OF ERECTIILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Teva
UBS
Moodys
Chubb
Medtronic
Argus Health
Accenture
Harvard Business School

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