Ertugliflozin - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for ertugliflozin and what is the scope of patent protection?
Ertugliflozin
is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd and Msd Sub Merck, and is included in four NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ertugliflozin has sixty patent family members in forty-nine countries.
Two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ertugliflozin
| International Patents: | 60 |
| US Patents: | 5 |
| Tradenames: | 4 |
| Applicants: | 2 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 39 |
| Patent Applications: | 100 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ertugliflozin |
| What excipients (inactive ingredients) are in ertugliflozin? | ertugliflozin excipients list |
| DailyMed Link: | ertugliflozin at DailyMed |
Recent Clinical Trials for ertugliflozin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ain Shams University | Phase 2/Phase 3 |
| Getz Pharma | Phase 4 |
| Case Western Reserve University | Phase 4 |
Generic filers with tentative approvals for ERTUGLIFLOZIN
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Anatomical Therapeutic Chemical (ATC) Classes for ertugliflozin
Paragraph IV (Patent) Challenges for ERTUGLIFLOZIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| STEGLATRO | Tablets | ertugliflozin | 5 mg and 15 mg | 209803 | 3 | 2021-12-20 |
US Patents and Regulatory Information for ertugliflozin
EU/EMA Drug Approvals for ertugliflozin
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp & Dohme B.V. | Steglatro | ertugliflozin | EMEA/H/C/004315 Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.in addition to other medicinal products for the treatment of diabetes. |
Authorised | no | no | no | 2018-03-21 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ertugliflozin
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Peru | 20110288 | DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL | ⤷ Sign Up |
| China | 103497199 | Dioxa-bicyclo[3.2.1]octane-2, 3, 4-triol derivatives | ⤷ Sign Up |
| Poland | 2334687 | ⤷ Sign Up | |
| Dominican Republic | P2011000058 | DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL UTILES PARA USAR COMO INHIBIDORES DEL TRANSPORTADOR DE SODIO-GLUCOSA | ⤷ Sign Up |
| Panama | 8840801 | DERIVAOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL | ⤷ Sign Up |
| Australia | 2009286380 | Dioxa-bicyclo(3.2.1.)octane-2,3,4-triol derivatives | ⤷ Sign Up |
| Mexico | 2011002166 | DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,1-TRIOL. (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ertugliflozin
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2334687 | 2018/028 | Ireland | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 20180321 |
| 2334687 | C02334687/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: PFIZER INC., US |
| 2334687 | 2018C/027 | Belgium | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, EN SPECIFIEK ALS ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323 |
| 2334687 | CR 2018 00025 | Denmark | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZIN, EVENTUELT SOM EN KRYSTALFORM, SAERLIGT SOM ET CO-KRYSTAL MED L-PYROGLUTAMINSYRE OG SPECIFIKT SOM ERTUGLIFLOZIN-L-PYROGLUTAMINSYRE; NAT. REG. NO/DATE: EU/1/18/1267/001-012 20180323; FIRST REG. NO/DATE: EU EU/1/18/1267/001/012 20180323 |
| 2334687 | CA 2018 00025 | Denmark | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZIN, EVENTUELT SOM EN KRYSTALFORM, SAERLIGT SOM ET CO-KRYSTAL MED L-PYROGLUTAMINSYRE OG SPECIFIKT SOM ERTUGLIFLOZIN-L-PYROGLUTAMINSYRE; NAT. REG. NO/DATE: EU/1/18/1267/001-012 20180323; FIRST REG. NO/DATE: EU EU/1/18/1267/001/012 20180323 |
| 2334687 | 122018000070 | Germany | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZIN, EINSCHLIESSLICH KRISTALL UMFASSEND ERTUGLIFLOZIN UND ERTUGLIFLOZIN UND L-PYROGLUTAMINSAEURE ALS CO-KRISTALL; REGISTRATION NO/DATE: EU/1/18/1267 20180321 |
| 2334687 | LUC00079 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZINE, EVENTUELLEMENT SOUS FORME CRISTALLINE, EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTAMIQUE, ET PLUS SPECIFIQUEMENT EN TANT QU'ACIDE ERTUGLIFLOZINE L-PYROGLUTAMIQUE; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
