Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
Covington
Moodys
Cerilliant
Harvard Business School
Teva
Boehringer Ingelheim
Cipla

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022328

« Back to Dashboard

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-two drug master file entries for this compound. Sixty-five 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
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 N 59011-255-05
INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328 NDA Purdue Pharma LP 59011-255 N 59011-255-30

Profile for product number 001

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Moodys
Merck
Johnson and Johnson
Cerilliant
Citi
UBS
Deloitte
Baxter

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.