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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
AstraZeneca
US Department of Justice
US Army
Merck
QuintilesIMS
Baxter
Daiichi Sankyo
Fish and Richardson

Generated: July 17, 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.
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
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 Date
➤ Subscribe Sublingual Tablets 5 mg and 10 mg ➤ Subscribe ➤ Sign Up

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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Supplementary Protection Certificates for EDLUAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
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:

Teva
Daiichi Sankyo
Moodys
Cantor Fitzgerald
Federal Trade Commission
Julphar
Cipla
UBS
Mallinckrodt

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