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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022328


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NDA 022328 describes INTERMEZZO, which is a drug marketed by Purdue Pharma and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INTERMEZZO profile page.

The generic ingredient in INTERMEZZO is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 022328
Tradename:INTERMEZZO
Applicant:Purdue Pharma
Ingredient:zolpidem tartrate
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 022328
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 022328
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328 NDA Purdue Pharma LP 59011-256 59011-256-05 5 CARTON in 1 TRAY (59011-256-05) > 1 POUCH in 1 CARTON > 1 TABLET in 1 POUCH
INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328 NDA Purdue Pharma LP 59011-256 59011-256-30 30 POUCH in 1 CARTON (59011-256-30) > 1 TABLET in 1 POUCH
Paragraph IV (Patent) Challenges for 022328
Tradename Dosage Ingredient NDA Submissiondate
INTERMEZZO TABLET;SUBLINGUAL zolpidem tartrate 022328 2012-04-10

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrength1.75MG
Approval Date:Nov 23, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 15, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD FOR TREATING INSOMNIA
Patent:  Start TrialPatent Expiration:Feb 16, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TREATING INSOMNIA
Patent:  Start TrialPatent Expiration:Aug 20, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA

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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
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McKesson
Harvard Business School
Express Scripts

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