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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Chubb
Mallinckrodt
Julphar
Fish and Richardson
Argus Health
US Army
Medtronic
Fuji

Generated: June 18, 2018

DrugPatentWatch Database Preview

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.
Drug patent expirations by year for INTERMEZZO
Pharmacology for INTERMEZZO

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

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Paragraph IV (Patent) Challenges for INTERMEZZO
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Sublingual Tablets 1.75 mg and 3.5 mg ➤ Subscribe 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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for INTERMEZZO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
636 Luxembourg ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00714 Netherlands ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
0714 Netherlands ➤ Try a Free Trial 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 ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Baxter
Covington
Fuji
Deloitte
QuintilesIMS
Argus Health
Dow
Mallinckrodt

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