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Generated: December 17, 2017

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-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 022328

Tradename:1
Applicant:1
Ingredient:1
Patents:4
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 022328

Ingredient-typePyridines
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 59011-255 59011-255-05 5 CARTON in 1 TRAY (59011-255-05) > 1 POUCH in 1 CARTON > 1 TABLET in 1 POUCH
INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328 NDA Purdue Pharma LP 59011-255 59011-255-30 30 POUCH in 1 CARTON (59011-255-30) > 1 TABLET in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength1.75MG
Approval Date:Nov 23, 2011TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Apr 15, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD FOR TREATING INSOMNIA
Patent:► SubscribePatent Expiration:Feb 16, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TREATING INSOMNIA
Patent:► SubscribePatent 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:

Harvard Business School
US Army
Covington
Chubb
AstraZeneca
Queensland Health
Chinese Patent Office
Merck
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Teva

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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