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Last Updated: July 6, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022033


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NDA 022033 describes LUVOX CR, which is a drug marketed by Jazz Pharms and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the LUVOX CR profile page.

The generic ingredient in LUVOX CR is fluvoxamine maleate. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.
Summary for 022033
Tradename:LUVOX CR
Applicant:Jazz Pharms
Ingredient:fluvoxamine maleate
Patents:1
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 022033
Tradename Dosage Ingredient NDA Submissiondate
LUVOX CR CAPSULE, EXTENDED RELEASE;ORAL fluvoxamine maleate 022033 2009-04-20
LUVOX CR CAPSULE, EXTENDED RELEASE;ORAL fluvoxamine maleate 022033 2009-04-13

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 28, 2008TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 10, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OBSESSIVE COMPULSIVE DISORDER TREATABLE WITH AN SSRI

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 28, 2008TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 10, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OBSESSIVE COMPULSIVE DISORDER TREATABLE WITH AN SSRI

Expired US Patents for NDA 022033

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Jazz Pharms LUVOX CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 022033-001 Feb 28, 2008   Start Trial   Start Trial
Jazz Pharms LUVOX CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 022033-002 Feb 28, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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