Last reviewed · How we verify
METFORMIN generic
52 approved generics
Patents expired
About METFORMIN
METFORMIN. Class: Dipeptidyl Peptidase 4 Inhibitor [EPC]. First approved 1995-01-01.
Approved generic versions (52)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| Glucophage | Generic (originally Merck Serono/Lipha) | marketed | 1995-03-03 | United States |
| METFORMIN HYDROCHLORIDE | marketed | 1995-01-01 | ||
| metformine | Semnan University of Medical Sciences | marketed | ||
| Metformin plus folic acid | University Magna Graecia | marketed | ||
| metformin and roflumilast | University Medical Centre Ljubljana | marketed | ||
| Metformin hydrochoride | University of Massachusetts, Worcester | marketed | ||
| metforminhydrochloride | Tampere University Hospital | marketed | ||
| Metformin + Clomiphene | University of Auckland, New Zealand | marketed | ||
| Metformin Pill | MTI University | marketed | ||
| Metformin / Placebo treatment for 4 months | Norwegian University of Science and Technology | marketed | ||
| Metformin, Pioglitazone | Khyber Medical University Peshawar | marketed | ||
| Metformin Tablets | Guangdong Raynovent Biotech Co., Ltd | marketed | ||
| Metformin ER | Matthew Neal MD | marketed | ||
| Metformin Retard 850 mg | Damanhour University | marketed | ||
| metformin, gliclazide, protaphane | Chinese University of Hong Kong | marketed | ||
| Metformin / alogliptin Oral Product | University of Catanzaro | marketed | ||
| Metformin hydrochlorid | Boehringer Ingelheim | marketed | ||
| Metformin / clomid / hCG | The Egyptian IVF-ET Center | marketed | ||
| metformin and rosiglitazone | New York Medical College | marketed | ||
| Metformin and standard exercise | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | marketed | ||
| Metformin-GLP-1 Receptor Agonist | Xinqiao Hospital of Chongqing | marketed | ||
| metformin+ gliclazide | GlaxoSmithKline | marketed | ||
| Metformin discontinue | University of Texas Southwestern Medical Center | marketed | ||
| metformin\pioglitazone\exenatide | The University of Texas Health Science Center at San Antonio | marketed | ||
| metformin or sulfonylurea | Dr. Milan Gupta | marketed | ||
| Metformin and insulin | Takeda | marketed | ||
| metformin/glimepiride combination | Laboratorios Silanes S.A. de C.V. | marketed | ||
| Metformin plus vildagliptin | Sheba Medical Center | marketed | ||
| Metformin up-titration | Research Clinical Centre of the Russian Railways, JSC | marketed | ||
| "Metformin" and "Rosuvastatin" seperately | Jeil Pharmaceutical Co., Ltd. | marketed | ||
| Metformin and Saxagliptin | ikfe-CRO GmbH | marketed | ||
| Metformin + Insulin | University of Virginia | marketed | ||
| metformin+sibutramine | Promomed, LLC | marketed | ||
| Metformin and FSHr | Assistance Publique - Hôpitaux de Paris | marketed | ||
| "Metformin" and "Mitiglinide" | Third Affiliated Hospital of Third Military Medical University | marketed | ||
| metformin, glyburide and glargine | The University of Texas Health Science Center at San Antonio | marketed | ||
| metformin + glimepiride | GlaxoSmithKline | marketed | ||
| Metformin / Pioglitazone Pill | University of Catanzaro | marketed | ||
| Metformin IR | AstraZeneca | marketed | ||
| metformin, rosiglitazone | University Medical Centre Ljubljana | marketed | ||
| Metformin and Pioglitazone | King Edward Medical University | marketed | ||
| Metformin only | Sheba Medical Center | marketed | ||
| Metformin, dipyridamole | Radboud University Medical Center | marketed | ||
| Metformin Therapy | Temple University | marketed | ||
| Metformin cloridrate | University Magna Graecia | marketed | ||
| Metformin plus clomiphene citrate | University Magna Graecia | marketed | ||
| metformin and liraglutide | University Medical Centre Ljubljana | marketed | ||
| Metformin Small Pack | GlaxoSmithKline | marketed | ||
| metformin 0.85 twice daily for 6 months | Xiang Guang-da | marketed | ||
| Metformin Large Pack | GlaxoSmithKline | marketed | ||
| Metformin Intensive exercise | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | marketed | ||
| Metformin continue | University of Texas Southwestern Medical Center | marketed |
Originator patent timeline
Active patents (0)
Expired patents (0)
How small-molecule generic approval works
Generic versions of small-molecule drugs are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway under the Hatch-Waxman Act of 1984. Sponsors must demonstrate bioequivalence (pharmacokinetic equivalence within tight bounds) and identical chemical composition — no clinical trials in patients are required. Approval typically takes 18-24 months.
This is different from biosimilars for biologic drugs, which use the more complex 351(k) BLA pathway and typically achieve smaller (15-35%) discounts vs the originator. Small-molecule generics typically launch at 60-80% discount, dropping to 85-95% within 2 years.