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Generated: April 24, 2019

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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-three drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-002 Nov 23, 2011 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-001 Nov 23, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-002 Nov 23, 2011 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-001 Nov 23, 2011 AB RX 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

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Paragraph IV (Patent) Challenges for INTERMEZZO
Drugname Dosage Strength RLD Date
➤ Subscribe Sublingual Tablets 1.75 mg and 3.5 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for INTERMEZZO

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

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