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Last Updated: May 19, 2022

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-seven 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-seven 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 23rd, 2007.

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Drug patent expirations by year for INTERMEZZO
Drug Prices for INTERMEZZO

See drug prices for INTERMEZZO

Drug Sales Revenue Trends for INTERMEZZO

See drug sales revenues for INTERMEZZO

Recent Clinical Trials for INTERMEZZO

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

SponsorPhase
Transcept PharmaceuticalsPhase 3

See all INTERMEZZO clinical trials

Pharmacology for INTERMEZZO
Anatomical Therapeutic Chemical (ATC) Classes for INTERMEZZO
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING INSOMNIA

Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING INSOMNIA

Methods of treating middle-of-the-night insomnia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA

Compositions for treating insomnia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-002 Nov 23, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-001 Nov 23, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-002 Nov 23, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-001 Nov 23, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-001 Nov 23, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-002 Nov 23, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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.

Country Patent Number Title Estimated Expiration
South Korea 20130116378 COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF See Plans and Pricing
European Patent Office 1883408 COMPOSITIONS SOLIDES ET TECHNIQUES DE TRAITEMENT D'INSOMNIE SURVENANT AU MILIEU DE LA NUIT (SOLID COMPOSITIONS AND METHODS FOR TREATING MIDDLE-OF-THE NIGHT INSOMNIA) See Plans and Pricing
Japan 5179757 See Plans and Pricing
Brazil PI0507733 composição para a liberação de um agente hipnótico através da mucosa oral, e, método para tratar um distúrbio do sono em um paciente em necessidade deste See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006017813 See Plans and Pricing
Australia 2006249761 Solid compositions and methods for treating middle-of-the night insomnia See Plans and Pricing
New Zealand 563979 Solid compositions and methods for treating middle-of-the night insomnia See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INTERMEZZO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 92636 Luxembourg See Plans and Pricing PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132 300714 Netherlands See Plans and Pricing PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 CA 2015 00004 Denmark See Plans and Pricing 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
2236132 122015000006 Germany See Plans and Pricing 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 C300714 Netherlands See Plans and Pricing PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt
Moodys
Harvard Business School
Express Scripts

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