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Serving leading biopharmaceutical companies globally:

Queensland Health
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Express Scripts
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Farmers Insurance
Dow
Argus Health
US Army
Cipla
McKinsey

Generated: December 18, 2017

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 and five supplementary protection certificates in four countries.

The generic ingredient in INTERMEZZO is zolpidem tartrate. There are thirty-one drug master file entries for this compound. Sixty-six 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue PharmaINTERMEZZOzolpidem tartrateTABLET;SUBLINGUAL022328-001Nov 23, 2011ABRXYesNo► Subscribe► SubscribeY► Subscribe
Purdue PharmaINTERMEZZOzolpidem tartrateTABLET;SUBLINGUAL022328-002Nov 23, 2011ABRXYesYes► Subscribe► Subscribe► Subscribe
Purdue PharmaINTERMEZZOzolpidem tartrateTABLET;SUBLINGUAL022328-001Nov 23, 2011ABRXYesNo► Subscribe► SubscribeY► Subscribe
Purdue PharmaINTERMEZZOzolpidem tartrateTABLET;SUBLINGUAL022328-002Nov 23, 2011ABRXYesYes► Subscribe► SubscribeY► Subscribe
Purdue PharmaINTERMEZZOzolpidem tartrateTABLET;SUBLINGUAL022328-001Nov 23, 2011ABRXYesNo► Subscribe► Subscribe► Subscribe
Purdue PharmaINTERMEZZOzolpidem tartrateTABLET;SUBLINGUAL022328-001Nov 23, 2011ABRXYesNo► Subscribe► Subscribe► Subscribe
Purdue PharmaINTERMEZZOzolpidem tartrateTABLET;SUBLINGUAL022328-002Nov 23, 2011ABRXYesYes► Subscribe► Subscribe► Subscribe
Purdue PharmaINTERMEZZOzolpidem tartrateTABLET;SUBLINGUAL022328-002Nov 23, 2011ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for INTERMEZZO

Drugname Dosage Strength RLD Submissiondate
zolpidem tartrateSublingual Tablets1.75 mg and 3.5 mgIntermezzo4/10/2012

Non-Orange Book Patents for Tradename: 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
8,097,431Methods and compositions for detecting steroids► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: INTERMEZZO

Country Document Number Estimated Expiration
South Korea20140104986► Subscribe
South Korea20160105935► Subscribe
European Patent Office1883408► Subscribe
World Intellectual Property Organization (WIPO)2006128022► Subscribe
Israel229039► Subscribe
BrazilPI0507733► Subscribe
Canada2556450► Subscribe
Japan2013040175► Subscribe
South Korea20070030178► Subscribe
South Korea20130006523► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: INTERMEZZO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2015000006Germany► SubscribePRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2015 00004Denmark► SubscribePRODUCT 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
0714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
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Serving leading biopharmaceutical companies globally:

Cerilliant
Medtronic
McKesson
Teva
Moodys
Federal Trade Commission
Harvard Business School
Accenture
Colorcon
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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