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Last Updated: July 6, 2020

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INTERMEZZO Drug 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-eight suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

US ANDA 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

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Drug Sales Revenue Trends for INTERMEZZO

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Recent Clinical Trials for INTERMEZZO

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SponsorPhase
Transcept PharmaceuticalsPhase 3

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Pharmacology for INTERMEZZO
Paragraph IV (Patent) Challenges for INTERMEZZO
Tradename Dosage Ingredient NDA Submissiondate
INTERMEZZO TABLET;SUBLINGUAL zolpidem tartrate 022328 2012-04-10

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

Supplementary Protection Certificates for INTERMEZZO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 122015000006 Germany   Start Trial 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 300714 Netherlands   Start Trial 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   Start Trial 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 92636 Luxembourg   Start Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132 C300714 Netherlands   Start Trial 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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