Table 3.
European Medicines Agency (EMA)-approved generic medicines for DPP4 inhibition.
| Brand Name | Active Ingredient(s) | Generic | Company | EMA No. 1 | Approval Date 2 |
|---|---|---|---|---|---|
| Sitagliptin SUN | Sitagliptin fumarate | Januvia | Sun Pharmaceutical Industries Europe B.V. (Hoofddorp, Netherlands) | 005741 | 09/12/2021 |
| Sitagliptin/Metformin hydrochloride Mylan | Sitagliptin hydrochloride monohydrate and metformin hydrochloride | Janumet | Mylan Ireland Limited (Dublin, Irland) | 005678 | 16/02/2022 |
| Sitagliptin Accord | Sitagliptin | Januvia | Accord Healthcare S.L.U. (Barcelona, Spain) | 005598 | 25/04/2022 |
| Sitagliptin/Metformin hydrochloride Accord | Sitagliptin and metformin hydrochloride | Janumet | Accord Healthcare S.L.U. | 005850 | − 3 |
| Vildagliptin/Metformin hydrochloride Accord | Vildagliptin and metformin hydrochloride | Eucreas | Accord Healthcare S.L.U. | 005738 | 24/03/2022 (AM) |
1 EMA product number should be indicated as follows: EMEA/H/C/XXXXXX. 2 Date of issue of marketing authorization (day/ month/year) valid throughout the European Union. 3 A positive opinion recommending the granting of a marketing authorization for this drug was adopted on 19/05/2022. AM, additional monitoring. It means that this drug is more intensively monitored than other medicines.