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Last Updated: May 19, 2024

EDLUAR Drug Patent Profile


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Which patents cover Edluar, and when can generic versions of Edluar launch?

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

This drug has twenty patent family members in twelve countries.

The generic ingredient in EDLUAR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Edluar

A generic version of EDLUAR was approved as zolpidem tartrate by ACME LABS on April 23rd, 2007.

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Paragraph IV (Patent) Challenges for EDLUAR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EDLUAR Sublingual Tablets zolpidem tartrate 5 mg and 10 mg 021997 1 2010-04-29

US Patents and Regulatory Information for EDLUAR

EDLUAR is protected by two US patents.

Patents protecting EDLUAR

Pharmaceutical formulations useful in the treatment of insomnia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET

Pharmaceutical formulations useful in the treatment of insomnia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for EDLUAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for EDLUAR

See the table below for patents covering EDLUAR around the world.

Country Patent Number Title Estimated Expiration
Canada 2345121 COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT DES MALADIES AIGUES (PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF ACUTE DISORDERS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006046041 ⤷  Try a Trial
Estonia 200100182 ⤷  Try a Trial
European Patent Office 2805716 Composition pharmaceutique comprenant la buprĂ©norphine ayant une action rapide (A pharmaceutical composition comprising buprenorphine having a rapid action) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EDLUAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 300714 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 122015000006 Germany ⤷  Try a Trial 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
2236132 CA 2015 00004 Denmark ⤷  Try a Trial 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
2236132 484 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.