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.
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.
Latest Legal Activities on Zolpidem Tartrate's Patents
Given below is the list recent legal activities going on the following patents of Zolpidem Tartrate.
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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.
1. 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
2. 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
Manufacturing Plant Locations
New
Actavis Elizabeth's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Elizabeth as present at those locations.
Country
City
Firm Name
United States
Elizabeth
Actavis Elizabeth LLC, A Company of Teva
3. 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
4. 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
Manufacturing Plant Locations
New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
Country
City
Firm Name
United States
Weston
Apotex Corp.
Canada
North York
Apotex Inc.
Winnipeg
Apotex Fermentation Inc.
Etobicoke
Apotex, Inc.
Brantford
Apotex Pharmachem Inc.
Toronto
Apotex Inc.
Richmond Hill
Apotex Inc.
India
Bangalore
Apotex Pharmachem India Pvt Ltd.
Bengaluru
Apotex Research Private Limited
Bangalore
Apotex Research Private Limited - Bioequivalence Centre
5. 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
Manufacturing Plant Locations
New
Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.
Country
City
Firm Name
Canada
Toronto
Apotex Inc.
North York
Apotex Inc.
Richmond Hill
Apotex Inc.
6. 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
Manufacturing Plant Locations
New
Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.
Country
City
Firm Name
India
Medchal
Aurobindo Pharma Ltd
Sangareddy
Aurobindo Pharma Limited
Bachupally
Aurobindo Pharma Limited
Polepally, Mahaboob Nagar
Aurobindo Pharma Limited
United States
East Windsor
Aurobindo Pharma USA Inc
7. 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
Manufacturing Plant Locations
New
Breckenridge's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Breckenridge as present at those locations.
Country
City
Firm Name
United States
Berlin
Breckenridge Pharmaceutical, Inc
Boca Raton
Breckenridge Pharmaceutical, Inc.
8. 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
9. 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
10. 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
11. 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
12. 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
Manufacturing Plant Locations
New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
Country
City
Firm Name
United States
Eatontown
Hikma Pharmaceuticals USA, Inc.
Carlsbad
Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill
Hikma Pharmaceuticals USA Inc.
Dayton
Hikma Injectables USA Inc
Portugal
Terrugem Snt
Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman
Hikma Pharmaceuticals LLC
13. 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
14. 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
Manufacturing Plant Locations
New
Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.
Country
City
Firm Name
India
Aurangabad
Lupin Ltd.
15. 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
16. NORVIUM BIOSCIENCE
Norvium Bioscience 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
Norvium Bioscience.
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
17. 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
18. 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
Manufacturing Plant Locations
New
Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.
Country
City
Firm Name
United States
Rising Sun
Rising Sun Veterinary Clinic
Mount Morris
Rising Creek Bakery LLC
Livingston
Risingsun Iodine Products Corp.
Saddle Brook
Rising Pharmaceuticals, Inc.
Phoenix
Rising Sun Farms Inc
Flagstaff
Rising High Enterprises, LLC (DBA RisingHy)
Fort Bragg
Rising Tide Sea Vegetables
Decatur
Rising Pharma Holdings, Inc
East Brunswick
Rising Pharma Holding, Inc.
Mexico
Pueblo San Clemente
RISING FARMS SAPI DE CV
India
Ahmedabad
Rising Retina Clinic
19. 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
Manufacturing Plant Locations
New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
Country
City
Firm Name
Austria
Kundl
Sandoz GmbH
Langkampfen
Sandoz GmbH
United States
East Hanover
Sandoz Incorporated
Princeton
Sandoz Inc
Spain
Palafolls
Sandoz Industrial Products, S.A.
Les Franqueses Del Valles
Sandoz Industrial Products S.A.
India
Navi Mumbai
Sandoz Private Limited
20. 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
Manufacturing Plant Locations
New
Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.
Country
City
Firm Name
United States
East Brunswick
Strides Pharma Inc.
Chestnut Ridge
Strides Pharma, Inc.
India
Bangalore
Strides Pharma Science Limited
Puducherry
Strides Pharma Science Limited
21. 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
Manufacturing Plant Locations
New
Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.
Country
City
Firm Name
United States
Billerica
Sun Pharmaceutical Industries, Inc.
Princeton
SUN PHARMACEUTICAL INDUSTRIES INC
Lexington
Sun Pharmaceutical Industries Inc
India
Gurugram
Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Kanchipuram
Sun Pharmaceutical Industries Limited- Madhuranthagam
Punjab
Sun Pharmaceutical Industries, Inc.
Vadodara
Sun Pharmaceutical Industries Ltd.
Halol
Sun Pharmaceutical Industries Ltd.
Dadra
Sun Pharmaceutical Industries Limited
Bharuch
Sun Pharmaceutical Industries Ltd
Baruch
Sun Pharmaceutical Industries Ltd.
Ahmednagar
Sun Pharmaceutical Industries Limited
Mohali
Sun Pharmaceutical Industries Limited
Vadodara
Sun Pharmaceutical Industries Limited - Karkhadi
Malanpur, Bhind (District)
Sun Pharmaceutical Industries Limited
New Delhi
Sun Pharmaceutical Industries Limited
Vadodara
Sun Pharmaceutical Industries Ltd
22. 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
23. 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
24. 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
25. 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
26. 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
Manufacturing Plant Locations
New
Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.
Country
City
Firm Name
United States
Miami
Teva Branded Pharmaceutical Products R & D, Inc.
Fort Dodge
TEVA Animal Health Inc
Malvern
Teva Branded Pharmaceutical Products R&D, Inc.
Horsham
Teva Branded Pharmaceutical Products R&D
India
Gajraula, Amroha
Teva API India Private Ltd.
Bhind
Teva API India Ltd- Malanpur
Canada
Markham
Teva Canada Limited
Stouffville
Teva Canada Limited
Scarborough
Teva Canada Limited
Czech Republic
Opava
Teva Czech Industries s.r.o.
Ireland
Dundalk
Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona
TEVA Medical Ltd.
27. 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
28. 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
29. 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
Manufacturing Plant Locations
New
Wockhardt's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Wockhardt as present at those locations.
Country
City
Firm Name
India
Ankleshwar
Wockhardt, Ltd.
Solan, Nalagarh
Wockhardt Limited - Baddi
Aurangabad
Wockhardt Limited
30. 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
Manufacturing Plant Locations
New
Yung Shin Pharm's manufacturing plants are situated in 2 countries - China, Taiwan. Given below are the details of these plant locations as well as the firm names of Yung Shin Pharm as present at those locations.
