ERTUGLIFLOZIN - Generic Drug Details
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What are the generic drug sources for ertugliflozin and what is the scope of freedom to operate?
Ertugliflozin
is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd V, and Msd Sub Merck, and is included in five 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 is one tentative approval for this compound.
Summary for ERTUGLIFLOZIN
| International Patents: | 60 |
| US Patents: | 5 |
| Tradenames: | 4 |
| Applicants: | 3 |
| NDAs: | 5 |
| 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | STEGLUJAN | ertugliflozin; sitagliptin phosphate | TABLET;ORAL | 209805-001 | Dec 19, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Msd Sub Merck | SEGLUROMET | ertugliflozin; metformin hydrochloride | TABLET;ORAL | 209806-004 | Dec 19, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Sub Merck | STEGLATRO | ertugliflozin | TABLET;ORAL | 209803-002 | Dec 19, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
| Msd Sub Merck | SEGLUROMET | ertugliflozin; metformin hydrochloride | TABLET;ORAL | 209806-004 | Dec 19, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 |
|---|---|---|---|
| Malaysia | 155418 | DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES | ⤷ Sign Up |
| Ecuador | SP11010854 | DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL | ⤷ Sign Up |
| Cuba | 24003 | DERIVADOS DE DIOXA-BICICLO(3.2.1)OCTANO-2,3,4-TRIOL | ⤷ Sign Up |
| South Korea | 20110045093 | ⤷ 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 | 30/2018 | Austria | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZIN, GEGEBENENFALLS ALS KRISTALLFORM, INSBESONDERE ALS CO-KRISTALL MIT L-PYROGLUTAMINSAEURE, UND INSBESONDERE ALS ERTUGLIFLOZIN L-PYROGLUTAMINSAEURE; REGISTRATION NO/DATE: EU/1/18/1267 (MITTEILUNG) 20180323 |
| 2334687 | 392 18-2018 | Slovakia | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1267 20180323 |
| 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 |
| 2334687 | C201830047 | Spain | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZINA, OPICIONALMENTE EN FORMA CRISTALINA, PARTICULARMENTE COMO UN CO-CRISTAL CON ACIDO L-PIROGLUTAMICO, Y ESPECIFICAMENTE COMO ACIDO L-PIROGLUTAMICO DE ERTUGLIFLOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1267; DATE OF AUTHORISATION: 20180321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1267; DATE OF FIRST AUTHORISATION IN EEA: 20180321 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
