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Last Updated: December 19, 2025

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 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-seven 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

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:	⤷ Get Started Free	Patent Expiration:	Apr 15, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD FOR TREATING INSOMNIA
Patent:	⤷ Get Started Free	Patent Expiration:	Feb 16, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD FOR TREATING INSOMNIA
Patent:	⤷ Get Started Free	Patent Expiration:	Aug 20, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING MIDDLE-OF-THE-NIGHT 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	⤷ Get Started Free	⤷ Get Started Free
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011	⤷ Get Started Free	⤷ Get Started Free
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011	⤷ Get Started Free	⤷ Get Started Free
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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