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, Glucophage Xr, Riomet Er, Fortamet, Glumetza. 75 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
Riomet Er US9962336 Extended release suspension compositions May 01, 2035 Sun Pharm
Glumetza US7780987 Controlled release dosage forms Mar 23, 2025

(Expired)

Santarus Inc
Glumetza US8323692 Controlled release dosage forms Mar 23, 2025

(Expired)

Santarus Inc
Riomet US6890957 Liquid formulation of metformin Sep 14, 2023

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

Santarus Inc



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.

Activity Date Patent Number
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


Metformin Hydrochloride's Family Patents

Family Patents

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Metformin Hydrochloride Generic API Manufacturers

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 Bionpharma Inc and was approved on Apr 14, 2025.

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