Zolpidem Tartrate Patent Expiration

Zolpidem Tartrate was first introduced by Cosette Pharmaceuticals Inc in its drug Ambien on Dec 16, 1992. Other drugs containing Zolpidem Tartrate are Edluar, Ambien Cr, Zolpidem Tartrate, Intermezzo, Zolpimist, Tovalt Odt. 36 different companies have introduced drugs containing Zolpidem Tartrate.


Zolpidem Tartrate Patents

Given below is the list of patents protecting Zolpidem Tartrate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zolpimist US8236285 Buccal, polar and non-polar spray containing zolpidem Aug 07, 2032 Aytu
Edluar US9265720 Pharmaceutical formulations useful in the treatment of insomnia Feb 25, 2031 Viatris
Intermezzo US8242131 Methods of treating middle-of-the-night insomnia Aug 20, 2029 Purdue Pharma
Intermezzo US7658945 Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof Apr 15, 2027 Purdue Pharma
Edluar US9597281 Pharmaceutical formulations useful in the treatment of insomnia Apr 06, 2027 Viatris
Intermezzo US7682628 Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof Feb 16, 2025

(Expired)

Purdue Pharma
Intermezzo US8252809 Compositions for treating insomnia Feb 16, 2025

(Expired)

Purdue Pharma
Ambien Cr US6514531

(Pediatric)

Controlled-release dosage forms comprising zolpidem or a salt thereof Jun 01, 2020

(Expired)

Cosette
Ambien Cr US6514531 Controlled-release dosage forms comprising zolpidem or a salt thereof Dec 01, 2019

(Expired)

Cosette
Edluar US6761910 Pharmaceutical composition for the treatment of acute disorders Sep 24, 2019

(Expired)

Viatris
Edluar US8512747 Pharmaceutical composition for the treatment of acute disorders Sep 24, 2019

(Expired)

Viatris
Zolpimist US7632517 Buccal, polar and non-polar spray containing zolpidem Oct 01, 2017

(Expired)

Aytu



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Zolpidem Tartrate's patents.

Given below is the list recent legal activities going on the following patents of Zolpidem Tartrate.

Activity Date Patent Number
Patent litigations
Expire Patent 15 Jan, 2018 US7632517
Expire Patent 02 Sep, 2016 US8236285
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 09 Apr, 2014 US7632517
Mail-Petition Decision - Accept Late Payment of Maintenance Fees - Granted 09 Apr, 2014 US7632517
Petition Decision - Accept Late Payment of Maintenance Fees - Granted 09 Apr, 2014 US7632517
Petition to Accept Late Payment of Maintenance Fee Payment Filed 09 Apr, 2014 US7632517
Expire Patent 10 Jan, 2014 US7632517
Patent Issue Date Used in PTA Calculation 07 Aug, 2012 US8236285
Recordation of Patent Grant Mailed 07 Aug, 2012 US8236285
Issue Notification Mailed 18 Jul, 2012 US8236285


Zolpidem Tartrate's Family Patents

Family Patents

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Zolpidem Tartrate Generic API Manufacturers

Several generic applications have been filed for Zolpidem Tartrate. The first generic version for Zolpidem Tartrate was by Sun Pharmaceutical Industries Inc and was approved on Apr 23, 2007. And the latest generic version is by Breckenridge Pharmaceutical Inc and was approved on Jun 4, 2020.

Given below is the list of companies who have filed for Zolpidem Tartrate generic, along with the locations of their manufacturing plants worldwide.