Metformin Hydrochloride Patent Expiration

Metformin Hydrochloride was first introduced by Emd Serono Inc in its drug Glucophage on Mar 3, 1995. Other drugs containing Metformin Hydrochloride are Riomet Er, Glucophage Xr, Riomet, Fortamet, Glumetza. 70 different companies have introduced drugs containing Metformin Hydrochloride.


Metformin Hydrochloride Patents

Given below is the list of patents protecting Metformin Hydrochloride, 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
Fortamet US6099859 Controlled release oral tablet having a unitary core Mar 20, 2018

(Expired)

Andrx Labs Llc
Fortamet US6495162 Controlled release oral tablet having a unitary core Mar 20, 2018

(Expired)

Andrx Labs Llc
Fortamet US6790459 Methods for treating diabetes via administration of controlled release metformin Mar 17, 2021

(Expired)

Andrx Labs Llc
Fortamet US6866866 Controlled release metformin compositions Mar 17, 2021

(Expired)

Andrx Labs Llc
Fortamet US7919116 Controlled release metformin formulations Mar 20, 2018

(Expired)

Andrx Labs Llc
Fortamet US8475841 Controlled release metformin formulations Mar 20, 2018

(Expired)

Andrx Labs Llc
Glucophage Xr US6475521 Biphasic controlled release delivery system for high solubility pharmaceuticals and method Mar 19, 2018

(Expired)

Emd Serono Inc
Glucophage Xr US6660300 Method of use of a biphasic controlled release delivery system for high solubility pharmaceuticals and method Mar 19, 2018

(Expired)

Emd Serono Inc
Glumetza US6340475 Extending the duration of drug release within the stomach during the fed mode Sep 19, 2016

(Expired)

Santarus Inc
Glumetza US6488962 Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Jun 20, 2020

(Expired)

Santarus Inc
Glumetza US6635280 Extending the duration of drug release within the stomach during the fed mode Sep 19, 2016

(Expired)

Santarus Inc
Glumetza US6723340 Optimal polymer mixtures for gastric retentive tablets Oct 25, 2021

(Expired)

Santarus Inc
Glumetza US7780987 Controlled release dosage forms Mar 23, 2025 Santarus Inc
Glumetza US8323692 Controlled release dosage forms Mar 23, 2025 Santarus Inc
Riomet US6890957 Liquid formulation of metformin Sep 14, 2023

(Expired)

Ranbaxy
Riomet Er US9962336 Extended release suspension compositions May 01, 2035 Sun Pharm


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 Metformin Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Metformin Hydrochloride.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 08 Nov, 2021 US9962336
Email Notification 21 Jan, 2021 US9962336
Change in Power of Attorney (May Include Associate POA) 21 Jan, 2021 US9962336
Correspondence Address Change 19 Jan, 2021 US9962336
Correspondence Address Change 20 Jul, 2020 US9962336
Recordation of Patent Grant Mailed 08 May, 2018 US9962336
Patent Issue Date Used in PTA Calculation 08 May, 2018 US9962336
Email Notification 19 Apr, 2018 US9962336
Issue Notification Mailed 18 Apr, 2018 US9962336
Application Is Considered Ready for Issue 30 Mar, 2018 US9962336



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Metformin Hydrochloride Generics

Several generic applications have been filed for Metformin Hydrochloride. The first generic version for Metformin Hydrochloride was by Chartwell Scheduled Llc and was approved on Jan 24, 2002. And the latest generic version is by Harman Finochem Ltd and was approved on Jul 5, 2024.

Given below is the list of companies who have filed for Metformin Hydrochloride generic.


1. QINGDAO BAHEAL PHARM

Qingdao Baheal Pharmaceutical Co Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Qingdao Baheal Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet, extended release Prescription ORAL AB2 Dec 27, 2018
500MG tablet, extended release Prescription ORAL AB2 Dec 27, 2018


2. ALIGNSCIENCE PHARMA

Alignscience Pharma Inc has filed for 1 generic for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Alignscience Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB1 Mar 19, 2018


3. HERITAGE PHARMA

Heritage Pharma Labs Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Heritage Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet Discontinued ORAL N/A Jan 25, 2002
850MG tablet Discontinued ORAL N/A Jan 25, 2002
1GM tablet Discontinued ORAL N/A Nov 5, 2002


4. BEXIMCO PHARMS USA

Beximco Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Beximco Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB1 Dec 13, 2016
750MG tablet, extended release Prescription ORAL AB Dec 13, 2016


5. NOSTRUM LABS INC

Nostrum Laboratories Inc has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Nostrum Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB2 Dec 26, 2017
1GM tablet, extended release Prescription ORAL AB2 Dec 26, 2017


6. MICRO LABS

Micro Labs Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB3 Jan 10, 2023
1GM tablet, extended release Prescription ORAL AB3 Jan 10, 2023


7. BARR

Barr Laboratories Inc has filed for 4 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
850MG tablet Discontinued ORAL N/A Jan 25, 2002
1GM tablet Discontinued ORAL N/A Jan 25, 2002
500MG tablet, extended release Discontinued ORAL N/A Nov 25, 2005
750MG tablet, extended release Discontinued ORAL N/A Oct 14, 2004


8. TEVA

Teva Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet Discontinued ORAL N/A Dec 16, 2002
850MG tablet Discontinued ORAL N/A Dec 16, 2002
500MG tablet, extended release Prescription ORAL AB1 Jun 18, 2004
750MG tablet, extended release Prescription ORAL AB Apr 12, 2005


9. IMPAX LABS

Impax Laboratories Inc has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Impax Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Discontinued ORAL N/A Jul 30, 2004
750MG tablet, extended release Discontinued ORAL N/A Sep 13, 2005


10. SUN PHARM INDS (IN)

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds (in).

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG tablet, extended release Prescription ORAL AB Feb 9, 2006
500MG tablet, extended release Prescription ORAL AB1 Feb 9, 2006


11. PROVIDENT PHARM

Provident Pharmaceutical Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Provident Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet Discontinued ORAL N/A Jul 28, 2006
500MG tablet Discontinued ORAL N/A Jul 28, 2006
850MG tablet Discontinued ORAL N/A Jul 28, 2006


12. ZYDUS PHARMS USA

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet Prescription ORAL AB Apr 18, 2005
850MG tablet Prescription ORAL AB Apr 18, 2005
1GM tablet Prescription ORAL AB Apr 18, 2005


13. UNICHEM

Unichem Laboratories Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Unichem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG tablet, extended release Prescription ORAL AB Aug 11, 2021
500MG tablet, extended release Prescription ORAL AB1 Aug 11, 2021


14. MARKSANS PHARMA

Marksans Pharma Ltd has filed for 4 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Marksans Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB1 Apr 29, 2016
850MG tablet Prescription ORAL AB Mar 12, 2012
1GM tablet Prescription ORAL AB Mar 12, 2012
750MG tablet, extended release Prescription ORAL AB Apr 29, 2016


15. IVAX SUB TEVA PHARMS

Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 5 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Ivax Sub Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Discontinued ORAL N/A Dec 1, 2003
850MG tablet Discontinued ORAL N/A Jan 24, 2002
1GM tablet Discontinued ORAL N/A Jan 24, 2002
625MG tablet Discontinued ORAL N/A Jan 24, 2002
750MG tablet Discontinued ORAL N/A Jan 24, 2002


16. VISTAPHARM

Vistapharm Inc has filed for 1 generic for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Vistapharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG/5ML solution Prescription ORAL AB Aug 19, 2022


17. SUNSHINE

Sunshine Lake Pharma Co Ltd has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Sunshine.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet Discontinued ORAL N/A Oct 12, 2018
850MG tablet Discontinued ORAL N/A Oct 12, 2018
500MG tablet Discontinued ORAL N/A Oct 12, 2018


18. IPCA LABS LTD

Ipca Laboratories Ltd has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Ipca Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet Discontinued ORAL N/A Aug 6, 2007
850MG tablet Discontinued ORAL N/A Aug 6, 2007
500MG tablet Discontinued ORAL N/A Aug 6, 2007


19. APOTEX

Apotex Inc has filed for 4 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB3 Dec 13, 2021
850MG tablet Prescription ORAL AB Dec 7, 2011
1GM tablet, extended release Prescription ORAL AB3 Dec 13, 2021
750MG tablet, extended release Discontinued ORAL N/A Dec 29, 2005


20. GRANULES INDIA

Granules India Ltd has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Granules India.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

(reference standard)

tablet Prescription ORAL AB Apr 22, 2010
500MG tablet Prescription ORAL AB Apr 22, 2010
850MG tablet Prescription ORAL AB Apr 22, 2010


21. RANBAXY LABS LTD

Ranbaxy Laboratories Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Ranbaxy Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Discontinued ORAL N/A Jun 18, 2004
750MG tablet, extended release Discontinued ORAL N/A Jun 29, 2005


22. WATSON LABS INC

Watson Laboratories Inc has filed for 1 generic for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Discontinued ORAL N/A Dec 14, 2004


23. SUN PHARM INDS INC

Sun Pharmaceutical Industries Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. 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
1GM tablet Discontinued ORAL N/A Jan 29, 2002
850MG tablet Discontinued ORAL N/A Jan 29, 2002
500MG tablet Discontinued ORAL N/A Jan 29, 2002


24. TORRENT PHARMS

Torrent Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Metformin Hydrochloride. 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
1GM tablet Discontinued ORAL N/A Jan 24, 2007
500MG tablet Discontinued ORAL N/A Jan 24, 2007
850MG tablet Discontinued ORAL N/A Jan 24, 2007


25. TORRENT

Torrent Pharmaceuticals Ltd has filed for 1 generic for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Discontinued ORAL N/A Dec 30, 2009


26. WATSON LABS

Watson Laboratories has filed for 3 different strengths of generic version for Metformin Hydrochloride. 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
500MG tablet Discontinued ORAL N/A Jan 24, 2002
850MG tablet Discontinued ORAL N/A Jan 24, 2002
1GM tablet Discontinued ORAL N/A Jan 24, 2002


27. LUPIN LTD

Lupin Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. 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
1GM tablet, extended release Prescription ORAL AB3 Jul 19, 2013
500MG tablet, extended release Prescription ORAL AB3 Jul 19, 2013


28. INTELLIPHARMACEUTICS

Intellipharmaceutics Corp has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Intellipharmaceutics.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB1 Feb 23, 2017
750MG tablet, extended release Prescription ORAL AB Feb 23, 2017


29. AMNEAL PHARMS NY

Amneal Pharmaceuticals Ny Llc has filed for 4 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal Pharms Ny.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet Prescription ORAL AB Jun 5, 2006
850MG tablet Prescription ORAL AB Jun 5, 2006
500MG tablet, extended release Prescription ORAL AB1 Jan 3, 2008
750MG tablet, extended release Prescription ORAL AB Jan 3, 2008


30. ZYDUS HLTHCARE

Zydus Healthcare Usa Llc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet Prescription ORAL AB Aug 28, 2014
850MG tablet Prescription ORAL AB Aug 28, 2014
500MG tablet Prescription ORAL AB Aug 28, 2014


31. LAURUS

Laurus Labs Ltd has filed for 4 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Laurus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB1 Oct 5, 2023
850MG tablet Prescription ORAL AB Aug 27, 2018
1GM tablet Prescription ORAL AB Aug 27, 2018
750MG tablet, extended release Prescription ORAL AB Oct 5, 2023


32. INDICUS PHARMA

Indicus Pharma Llc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Indicus Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet Discontinued ORAL N/A Nov 25, 2008
1GM tablet Discontinued ORAL N/A Nov 25, 2008
850MG tablet Discontinued ORAL N/A Nov 25, 2008


33. SAPTALIS PHARMS

Saptalis Pharmaceuticals Llc has filed for 1 generic for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Saptalis Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG/5ML

(reference standard)

solution Prescription ORAL AB Mar 3, 2020


34. RK PHARMA

Rk Pharma Inc has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Rk Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet, extended release Prescription ORAL AB3 Jun 20, 2023
500MG tablet, extended release Prescription ORAL AB3 Jun 20, 2023


35. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 2 different strengths of generic version for Metformin Hydrochloride. 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
500MG tablet, extended release Discontinued ORAL N/A Oct 1, 2004
750MG tablet, extended release Discontinued ORAL N/A Apr 13, 2005


36. WATSON LABS FLORIDA

Watson Laboratories Inc Florida has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Watson Labs Florida.

Strength Dosage Form Availability Application Pathway TE code Launch Date
850MG tablet Discontinued ORAL N/A Jan 25, 2002
500MG tablet Discontinued ORAL N/A Jan 25, 2002
1GM tablet Discontinued ORAL N/A Jan 25, 2002


37. TWI PHARMS

Twi Pharmaceuticals Inc has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Twi Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet, extended release Prescription ORAL AB2 Sep 29, 2021
500MG tablet, extended release Prescription ORAL AB2 Sep 29, 2021


38. HARMAN FINOCHEM

Harman Finochem Ltd has filed for 4 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Harman Finochem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
850MG tablet Prescription ORAL AB Dec 3, 2021
500MG tablet, extended release Prescription ORAL AB1 Jul 5, 2024
1GM tablet Prescription ORAL AB Dec 3, 2021
750MG tablet, extended release Prescription ORAL AB Jul 5, 2024


39. SANDOZ

Sandoz Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
850MG tablet Discontinued ORAL N/A Jan 25, 2002
500MG tablet, extended release Prescription ORAL AB1 Dec 14, 2004
1GM tablet Discontinued ORAL N/A Jan 25, 2002


40. NOSTRUM PHARMS LLC

Nostrum Pharmaceuticals Llc has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Nostrum Pharms Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB1 Jul 26, 2006
750MG tablet, extended release Prescription ORAL AB Dec 12, 2011


41. ALKEM

Alkem Laboratories Ltd has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Alkem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet Prescription ORAL AB Nov 1, 2010
850MG tablet Prescription ORAL AB Nov 1, 2010
1GM tablet Prescription ORAL AB Nov 1, 2010


42. CHARTWELL

Chartwell Scheduled Llc has filed for 5 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell.

Strength Dosage Form Availability Application Pathway TE code Launch Date
850MG tablet Prescription ORAL AB Jan 24, 2002
500MG tablet Prescription ORAL AB Jan 24, 2002
1GM tablet Prescription ORAL AB Jan 24, 2002
750MG tablet Prescription ORAL N/A Jan 24, 2002
625MG tablet Prescription ORAL N/A Jan 24, 2002


43. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
850MG tablet Prescription ORAL AB Sep 11, 2013
1GM tablet, extended release Prescription ORAL AB2 Feb 22, 2022
500MG tablet, extended release Prescription ORAL AB2 Feb 22, 2022


44. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Ajanta Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB3 Mar 9, 2021
1GM tablet, extended release Prescription ORAL AB3 Mar 9, 2021


45. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. 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
500MG tablet, extended release Discontinued ORAL N/A Dec 21, 2005
1GM tablet Discontinued ORAL N/A Feb 21, 2002
850MG tablet Discontinued ORAL N/A Feb 21, 2002


46. ATLAS PHARMS LLC

Atlas Pharmaceuticals Llc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Atlas Pharms Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet Prescription ORAL AB Jan 24, 2002
850MG tablet Prescription ORAL AB Jan 24, 2002
1GM tablet Prescription ORAL AB Jan 24, 2002


47. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB3 Jun 9, 2022
750MG tablet, extended release Prescription ORAL AB Sep 10, 2018
1GM tablet, extended release Prescription ORAL AB3 Jun 9, 2022


48. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 4 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet Discontinued ORAL N/A Oct 31, 2017
750MG tablet, extended release Prescription ORAL AB Dec 7, 2016
850MG tablet Discontinued ORAL N/A Oct 31, 2017
1GM tablet, extended release Prescription ORAL AB3 Mar 13, 2024


49. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB3 Nov 25, 2019
850MG tablet Prescription ORAL AB May 23, 2008
1GM tablet, extended release Prescription ORAL AB3 Nov 25, 2019


50. AUROBINDO

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurobindo.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet Prescription ORAL AB Jan 14, 2005
850MG tablet Prescription ORAL AB Jan 14, 2005
500MG tablet Prescription ORAL AB Jan 14, 2005


51. MYLAN

Mylan Pharmaceuticals Inc has filed for 4 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Discontinued ORAL N/A Sep 13, 2005
850MG tablet Prescription ORAL AB Jan 25, 2002
1GM tablet Prescription ORAL AB Jan 25, 2002
750MG tablet, extended release Discontinued ORAL N/A Sep 8, 2005


52. MYLAN PHARMS INC

Mylan Pharmaceuticals Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. 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
1GM tablet, extended release Prescription ORAL AB2 Aug 1, 2012
850MG tablet Discontinued ORAL N/A Jan 29, 2002
500MG tablet, extended release Prescription ORAL AB2 Aug 1, 2012


53. YICHANG HUMANWELL

Yichang Humanwell Pharmaceutical Co Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Yichang Humanwell.

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG tablet, extended release Prescription ORAL AB Sep 24, 2018
500MG tablet, extended release Prescription ORAL AB1 Sep 24, 2018


54. CSPC OUYI

Cspc Ouyi Pharmaceutical Co Ltd has filed for 4 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Cspc Ouyi.

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG tablet, extended release Prescription ORAL AB Apr 17, 2008
500MG tablet Prescription ORAL AB Jul 11, 2016
850MG tablet Prescription ORAL AB Jul 11, 2016
1GM tablet Prescription ORAL AB Jul 11, 2016


55. INVENTIA

Inventia Healthcare Ltd has filed for 1 generic for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Inventia.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB1 Jan 18, 2012


56. AUROBINDO PHARMA LTD

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG tablet, extended release Prescription ORAL AB Jul 20, 2012
500MG tablet, extended release Prescription ORAL AB1 Jul 20, 2012


57. TORRENT PHARMS LTD

Torrent Pharmaceuticals Ltd has filed for 1 generic for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Torrent Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG tablet, extended release Discontinued ORAL N/A Feb 18, 2010


58. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. 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
500MG tablet, extended release Prescription ORAL AB3 Aug 1, 2016
1GM tablet, extended release Prescription ORAL AB3 Aug 1, 2016


59. AMTA

Amta Labs Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Amta.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet, extended release Discontinued ORAL N/A Aug 3, 2021
500MG tablet, extended release Discontinued ORAL N/A Aug 3, 2021


60. EPIC PHARMA LLC

Epic Pharma Llc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet Prescription ORAL AB Jan 25, 2002
850MG tablet Prescription ORAL AB Jan 25, 2002
500MG tablet Prescription ORAL AB Jan 25, 2002


61. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG

(reference standard)

tablet, extended release Prescription ORAL AB Oct 22, 2018
500MG tablet, extended release Prescription ORAL AB1 Oct 22, 2018


62. NOVAST LABS

Novast Laboratories Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM tablet, extended release Prescription ORAL AB2 Nov 2, 2018
500MG tablet, extended release Prescription ORAL AB2 Nov 2, 2018


63. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 2 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB1 Apr 20, 2005
750MG tablet, extended release Prescription ORAL AB Apr 21, 2005


64. DR REDDYS LABS INC

Dr Reddys Laboratories Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet Prescription ORAL AB Aug 23, 2006
1GM tablet Prescription ORAL AB Aug 23, 2006
850MG tablet Prescription ORAL AB Aug 23, 2006


65. GRANULES

Granules India Ltd has filed for 3 different strengths of generic version for Metformin Hydrochloride. Given below are the details of the strengths of this generic introduced by Granules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG tablet, extended release Prescription ORAL AB3 Jan 12, 2021
750MG tablet, extended release Prescription ORAL AB Mar 16, 2018
1GM tablet, extended release Prescription ORAL AB3 Jan 12, 2021


66. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride. 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
500MG tablet, extended release Prescription ORAL AB3 Aug 1, 2016
750MG tablet, extended release Prescription ORAL AB Apr 12, 2005
1GM tablet, extended release Prescription ORAL AB3 Aug 1, 2016