Zolpidem Tartrate Patent Expiration

Zolpidem Tartrate was first introduced by Sanofi Aventis Us Llc in its drug Ambien on Dec 16, 1992. Other drugs containing Zolpidem Tartrate are Intermezzo, Tovalt Odt, Edluar, Zolpimist, Zolpidem Tartrate, Ambien Cr. 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
Ambien Cr US6514531 Controlled-release dosage forms comprising zolpidem or a salt thereof Dec 01, 2019

(Expired)

Sanofi Aventis Us
Ambien Cr US6514531

(Pediatric)

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

(Expired)

Sanofi Aventis Us
Edluar US6761910 Pharmaceutical composition for the treatment of acute disorders Sep 24, 2019

(Expired)

Mylan Speciality Lp
Edluar US8512747 Pharmaceutical composition for the treatment of acute disorders Sep 24, 2019

(Expired)

Mylan Speciality Lp
Edluar US9265720 Pharmaceutical formulations useful in the treatment of insomnia Feb 25, 2031 Mylan Speciality Lp
Edluar US9597281 Pharmaceutical formulations useful in the treatment of insomnia Apr 06, 2027 Mylan Speciality Lp
Intermezzo US7658945 Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof Apr 15, 2027 Purdue Pharma
Intermezzo US7682628 Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof Feb 16, 2025 Purdue Pharma
Intermezzo US8242131 Methods of treating middle-of-the-night insomnia Aug 20, 2029 Purdue Pharma
Intermezzo US8252809 Compositions for treating insomnia Feb 16, 2025 Purdue Pharma
Zolpimist US7632517 Buccal, polar and non-polar spray containing zolpidem Oct 01, 2017

(Expired)

Aytu
Zolpimist US8236285 Buccal, polar and non-polar spray containing zolpidem Aug 07, 2032 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.

Event Date Patent/Publication
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



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Zolpidem Tartrate Generics

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.


1. INVAGEN PHARMS

Invagen Pharmaceuticals Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Invagen Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Sep 7, 2007
10MG tablet Discontinued ORAL N/A Sep 7, 2007


2. APOTEX INC

Apotex Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Apr 23, 2007
10MG tablet Prescription ORAL AB Apr 23, 2007


3. TEVA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Apr 23, 2007
10MG tablet Prescription ORAL AB Apr 23, 2007


4. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Nov 21, 2008
10MG tablet Discontinued ORAL N/A Nov 21, 2008


5. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB May 4, 2007
5MG tablet Prescription ORAL AB May 4, 2007


6. SYNTHON PHARMS

Synthon Pharmaceuticals Inc has filed for 4 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Synthon Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Apr 23, 2007
10MG tablet Discontinued ORAL N/A Apr 23, 2007
6.25MG tablet, extended release Discontinued ORAL N/A Apr 12, 2011
12.5MG tablet, extended release Discontinued ORAL N/A Jun 6, 2011


7. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6.25MG tablet, extended release Prescription ORAL AB Sep 10, 2013
12.5MG tablet, extended release Prescription ORAL AB Sep 10, 2013


8. NOVEL LABS INC

Novel Laboratories Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Novel Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
3.5MG

(reference standard)

tablet Prescription SUBLINGUAL AB Jun 3, 2015
1.75MG tablet Prescription SUBLINGUAL AB Jun 3, 2015


9. SUN PHARM INDS INC

Sun Pharmaceutical Industries Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Apr 23, 2007
10MG tablet Discontinued ORAL N/A Apr 23, 2007


10. TORRENT PHARMS

Torrent Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Torrent Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Aug 17, 2007
5MG tablet Prescription ORAL AB Aug 17, 2007


11. HIKMA

Hikma Pharmaceuticals has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Apr 30, 2008
10MG tablet Discontinued ORAL N/A Apr 30, 2008


12. WATSON LABS

Watson Laboratories Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Apr 23, 2007
10MG tablet Discontinued ORAL N/A Apr 23, 2007


13. LUPIN LTD

Lupin Ltd has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6.25MG tablet, extended release Prescription ORAL AB Sep 11, 2013
12.5MG tablet, extended release Prescription ORAL AB Sep 11, 2013


14. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Apr 23, 2007
10MG tablet Discontinued ORAL N/A Apr 23, 2007


15. WOCKHARDT

Wockhardt Ltd has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Wockhardt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A May 15, 2007
10MG tablet Discontinued ORAL N/A May 15, 2007


16. ACTAVIS ELIZABETH

Actavis Elizabeth Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6.25MG tablet, extended release Discontinued ORAL N/A Oct 13, 2010
12.5MG tablet, extended release Discontinued ORAL N/A Jun 6, 2011


17. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Apr 23, 2007
10MG tablet Discontinued ORAL N/A Apr 23, 2007


18. SANDOZ

Sandoz Inc has filed for 4 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Apr 23, 2007
10MG tablet Prescription ORAL AB Apr 23, 2007
6.25MG tablet, extended release Prescription ORAL AB Jul 1, 2011
12.5MG tablet, extended release Prescription ORAL AB Jul 1, 2011


19. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Discontinued ORAL N/A Apr 23, 2007
5MG tablet Discontinued ORAL N/A Apr 23, 2007


20. YUNG SHIN PHARM

Yung Shin Pharmaceutical Industrial Co Ltd has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Yung Shin Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Apr 23, 2007
10MG tablet Discontinued ORAL N/A Apr 23, 2007


21. MYLAN PHARMS INC

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Mylan Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Apr 23, 2007
10MG tablet Discontinued ORAL N/A Apr 23, 2007


22. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Discontinued SUBLINGUAL N/A Aug 8, 2016
5MG tablet Discontinued SUBLINGUAL N/A Aug 8, 2016


23. DR REDDYS

Dr Reddys Laboratories Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.75MG tablet Prescription SUBLINGUAL AB Nov 18, 2016
3.5MG tablet Prescription SUBLINGUAL AB Nov 18, 2016


24. RISING

Rising Pharma Holding Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Apr 23, 2007
10MG tablet Discontinued ORAL N/A Apr 23, 2007


25. CHARTWELL MOLECULAR

Chartwell Molecular Holdings Llc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Chartwell Molecular.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Jul 30, 2012
10MG tablet Prescription ORAL AB Jul 30, 2012


26. ACME LABS

The Acme Laboratories Ltd has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Acme Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Apr 23, 2007
10MG tablet Prescription ORAL AB Apr 23, 2007


27. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6.25MG tablet, extended release Prescription ORAL AB Jan 24, 2017
12.5MG tablet, extended release Prescription ORAL AB Jan 24, 2017


28. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
12.5MG tablet, extended release Discontinued ORAL N/A Jun 4, 2020
6.25MG tablet, extended release Discontinued ORAL N/A Jun 4, 2020


29. ENDO OPERATIONS

Endo Operations Ltd has filed for 6 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
12.5MG tablet, extended release Discontinued ORAL N/A Dec 3, 2010
6.25MG tablet, extended release Discontinued ORAL N/A Apr 14, 2011
5MG tablet Prescription SUBLINGUAL AB Aug 1, 2016
10MG tablet Prescription SUBLINGUAL AB Aug 1, 2016
1.75MG tablet Prescription SUBLINGUAL AB Sep 11, 2017
3.5MG tablet Prescription SUBLINGUAL AB Sep 11, 2017


30. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 2 different strengths of generic version for Zolpidem Tartrate. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6.25MG tablet, extended release Discontinued ORAL N/A Mar 25, 2013
12.5MG tablet, extended release Discontinued ORAL N/A Mar 25, 2013