Last Updated: May 3, 2026

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. There are two 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-four 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:	2

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;SUBLINGUAL			Strength	1.75MG
Approval Date:	Nov 23, 2011	TE:		RLD:	Yes
Patent:	7,658,945	Patent Expiration:	Apr 15, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD FOR TREATING INSOMNIA
Patent:	8,242,131	Patent Expiration:	Aug 20, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;SUBLINGUAL			Strength	3.5MG
Approval Date:	Nov 23, 2011	TE:		RLD:	Yes
Patent:	7,658,945	Patent Expiration:	Apr 15, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD FOR TREATING INSOMNIA

Expired US Patents for NDA 022328

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011	7,682,628	⤷ Start Trial
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011	7,682,628	⤷ Start Trial
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011	8,252,809	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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