INTERMEZZO Drug Patent Profile

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When do Intermezzo patents expire, 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-five patent family members in thirteen countries.

The generic ingredient in INTERMEZZO is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Intermezzo

A generic version of INTERMEZZO was approved as zolpidem tartrate by ACME LABS on April 23^rd, 2007.

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Summary for INTERMEZZO

International Patents:	35
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	1
Drug Prices:	Drug price information for INTERMEZZO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INTERMEZZO
What excipients (inactive ingredients) are in INTERMEZZO?	INTERMEZZO excipients list
DailyMed Link:	INTERMEZZO at DailyMed

Drug patent expirations by year for INTERMEZZO

Recent Clinical Trials for INTERMEZZO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Transcept Pharmaceuticals	Phase 3

See all INTERMEZZO clinical trials

Paragraph IV (Patent) Challenges for INTERMEZZO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INTERMEZZO	Sublingual Tablets	zolpidem tartrate	1.75 mg and 3.5 mg	022328	1	2012-04-10

US Patents and Regulatory Information for INTERMEZZO

INTERMEZZO is protected by four US patents.

Patents protecting INTERMEZZO

Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
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Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR TREATING INSOMNIA

Methods of treating middle-of-the-night insomnia
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Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA

Compositions for treating insomnia
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Patent Expiration: ⤷ Sign Up

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Glossary

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

International Patents for INTERMEZZO

See the table below for patents covering INTERMEZZO around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	5179757		⤷ Sign Up
South Korea	20080031208	SOLID COMPOSITIONS AND METHODS FOR TREATING MIDDLE-OF-THE NIGHT INSOMNIA	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006017813		⤷ Sign Up
Japan	2007523091		⤷ Sign Up
South Korea	20130006523	COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF	⤷ Sign Up
South Korea	20130116378	COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for INTERMEZZO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	C300714	Netherlands	⤷ Sign Up	PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	300714	Netherlands	⤷ Sign Up	PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132	92636	Luxembourg	⤷ Sign Up	PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132	122015000006	Germany	⤷ Sign Up	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
2236132	CA 2015 00004	Denmark	⤷ Sign Up	PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description