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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
AstraZeneca
Covington
US Army
Chinese Patent Office
Teva
Chubb
Mallinckrodt
Fuji
Merck

Generated: June 24, 2017

DrugPatentWatch Database Preview

INTERMEZZO Drug Profile

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Which patents cover Intermezzo, and what generic Intermezzo 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-one 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.

Summary for Tradename: INTERMEZZO

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:INTERMEZZO at DailyMed

Pharmacology for Tradename: 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;SUBLINGUAL022328-001Nov 23, 2011ABRXYesNo8,252,809► SubscribeY ► Subscribe
Purdue Pharma
INTERMEZZO
zolpidem tartrate
TABLET;SUBLINGUAL022328-002Nov 23, 2011ABRXYesYes7,682,628► Subscribe ► Subscribe
Purdue Pharma
INTERMEZZO
zolpidem tartrate
TABLET;SUBLINGUAL022328-001Nov 23, 2011ABRXYesNo7,658,945► SubscribeY ► Subscribe
Purdue Pharma
INTERMEZZO
zolpidem tartrate
TABLET;SUBLINGUAL022328-002Nov 23, 2011ABRXYesYes7,658,945► SubscribeY ► Subscribe
Purdue Pharma
INTERMEZZO
zolpidem tartrate
TABLET;SUBLINGUAL022328-001Nov 23, 2011ABRXYesNo8,242,131► Subscribe ► Subscribe
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Paragraph IV activity 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
China100548281► Subscribe
Israel177227► Subscribe
South Korea20150038745► Subscribe
South Korea20130006523► Subscribe
Japan2007523091► 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
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
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
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
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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Johnson and Johnson
Medtronic
Julphar
Healthtrust
US Department of Justice
Dow
Deloitte
Baxter
McKesson

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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