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Serving leading biopharmaceutical companies globally:

McKesson
Fuji
Merck
UBS
Teva
Mallinckrodt
Queensland Health
Johnson and Johnson
Federal Trade Commission
Chinese Patent Office

Generated: February 21, 2018

DrugPatentWatch Database Preview

EDLUAR Drug Profile

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Which patents cover Edluar, and what generic 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 ninety-one patent family members in thirty-one countries.

The generic ingredient in EDLUAR is zolpidem tartrate. There are thirty-two 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.
Summary for EDLUAR
International Patents:91
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EDLUAR at DailyMed
Drug patent expirations by year for EDLUAR
Pharmacology for EDLUAR

US Patents and Regulatory Information for 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;SUBLINGUAL 021997-001 Mar 13, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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 EDLUAR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Sublingual Tablets 5 mg and 10 mg ➤ Subscribe 4/29/2010

Non-Orange Book US Patents for 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
7,910,132 Pharmaceutical composition for the treatment of acute disorders ➤ Sign Up
8,454,996 Pharmaceutical composition for the treatment of acute disorders ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for EDLUAR

Supplementary Protection Certificates for EDLUAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000006 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
636 Luxembourg ➤ Sign Up PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0714 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
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
4 Finland ➤ Sign Up
00714 Netherlands ➤ Sign Up PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Covington
McKesson
Daiichi Sankyo
AstraZeneca
Teva
US Army
Healthtrust
Medtronic

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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