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Serving leading biopharmaceutical companies globally:

Novartis
Harvard Business School
Baxter
Medtronic
Covington
Federal Trade Commission
Queensland Health
QuintilesIMS
Cerilliant
UBS

Generated: October 21, 2017

DrugPatentWatch Database Preview

EDLUAR Drug Profile

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Which patents cover Edluar, and what generic Edluar alternatives are available?

Edluar is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-five patent family members in thirty-one countries and five supplementary protection certificates in five countries.

The generic ingredient in EDLUAR 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.

Summary for Tradename: EDLUAR

US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EDLUAR at DailyMed

Pharmacology for Tradename: EDLUAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-001Mar 13, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-002Mar 13, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Mylan Speciality Lp
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-001Mar 13, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Mylan Speciality Lp
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-002Mar 13, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Mylan Speciality Lp
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-001Mar 13, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Mylan Speciality Lp
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-001Mar 13, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Mylan Speciality Lp
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-002Mar 13, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Mylan Speciality Lp
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-002Mar 13, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for EDLUAR

Drugname Dosage Strength RLD Submissiondate
zolpidem tartrateSublingual Tablets5 mg and 10 mgEdluar4/29/2010

Non-Orange Book Patents for Tradename: EDLUAR

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
7,910,132Pharmaceutical composition for the treatment of acute disorders► Subscribe
8,454,996Pharmaceutical composition for the treatment of acute disorders► 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: EDLUAR

Country Document Number Estimated Expiration
Australia764346► Subscribe
Spain2433930► Subscribe
World Intellectual Property Organization (WIPO)0016750► Subscribe
Australia6492799► Subscribe
Portugal2236133► Subscribe
Luxembourg92636► Subscribe
Denmark1115383► Subscribe
Cyprus1115685► Subscribe
European Patent Office2236132► Subscribe
Portugal1115383► 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: EDLUAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
4Finland► Subscribe
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Queensland Health
Federal Trade Commission
Cantor Fitzgerald
Deloitte
Covington
Healthtrust
Cerilliant
Fish and Richardson
US Department of Justice

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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