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INTERMEZZO Drug Profile

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Which patents cover Intermezzo, and what generic alternatives are available?

Intermezzo 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.

This drug has thirty-seven patent family members in thirteen countries.

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 INTERMEZZO

International Patents:	37
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	1
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INTERMEZZO
DailyMed Link:	INTERMEZZO at DailyMed

Pharmacology for INTERMEZZO

Ingredient-type	Pyridines
Drug Class	gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Agonists
Physiological Effect	Central Nervous System Depression

US Patents and Regulatory Information for INTERMEZZO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011	AB	RX	Yes	No			Y
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011	AB	RX	Yes	Yes
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011	AB	RX	Yes	No			Y
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011	AB	RX	Yes	Yes			Y

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Paragraph IV (Patent) Challenges for INTERMEZZO

Drugname	Dosage	Strength	RLD	Submissiondate
	Sublingual Tablets	1.75 mg and 3.5 mg		2012-04-10

Non-Orange Book US Patents for INTERMEZZO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,097,431	Methods and compositions for detecting steroids

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International Patents for INTERMEZZO

Country	Document Number	Estimated Expiration
Hong Kong	1118203
Canada	2609330
World Intellectual Property Organization (WIPO)	2005079761
Brazil	PI0609984

Supplementary Protection Certificates for INTERMEZZO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
0714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718