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 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 is one tentative approval 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: | 38 |
| Patent Applications: | 101 |
| 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 |
|---|---|
| Getz Pharma | Phase 4 |
| Yale University | Phase 4 |
| Case Western Reserve University | Phase 4 |
Generic filers with tentative approvals for ERTUGLIFLOZIN
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 15MG | TABLET;ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 5MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|
| South Korea | 101338540 | ⤷ Try a Trial | |
| Denmark | 2334687 | ⤷ Try a Trial | |
| Costa Rica | 20110077 | DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL | ⤷ Try a Trial |
| China | 102149717 | Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives | ⤷ Try a Trial |
| Nicaragua | 201100043 | DERIVADOS DE DIOXA - BICICLO [ 3. 2. 1 ] OCTANO - 2, 3, 4 - TRIOL. | ⤷ Try a Trial |
| Honduras | 2009001652 | DERIVADOS DE DIOXA- BICICLO [3.2.1] OCTANO -2,3,4-TRIOL | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ERTUGLIFLOZIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2334687 | SPC/GB18/026 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ERTUGLIFOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFOZIN L-PYROGLUTAMIC ACID; REGISTERED: UK EU/1/18/1267/001(NI) 20180321; UK EU/1/18/1267/002(NI) 20180321; UK EU/1/18/1267/003(NI) 20180321; UK EU/1/18/1267/004(NI) 20180321; UK EU/1/18/1267/005(NI) 20180321; UK EU/1/18/1267/006(NI) 20180321; UK PLGB 53095/0064 20180321; UK PLGB 53095/0065 20180321; UK EU/1/18/1267/007(NI) 20180321; UK EU/1/18/1267/008(NI) 20180321; UK EU/1/18/1267/009(NI) 20180321; UK EU/1/18/1267/010(NI) 20180321; UK EU/1/18/1267/011(NI) 20180321; UK EU/1/18/1267/012(NI) 20180321 |
| 2334687 | 132018000000441 | Italy | ⤷ Try a Trial | PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323 |
| 2334687 | PA2018510 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ERTUGLIFLOZINAS, PASIRINKTINAI KAIP KRISTALINE FORMA, YPAC KAIP KO-KRISTALAS SU L-PIROGLUTAMO RUGSTIMI, IR YPAC KAIP ERTUGLIFLOZINO L-PIROGLUTAMO RUGSTIS; REGISTRATION NO/DATE: EU/1/18/1267 20180321 |
| 2334687 | 2018C/027 | Belgium | ⤷ Try a Trial | 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 | PA2018510,C2334687 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ERTUGLIFLOZINAS, PASIRINKTINAI KAIP KRISTALINE FORMA, YPAC KAIP KO-KRISTALAS SU L-PIROGLUTAMO RUGSTIMI, IR YPAC KAIP ERTUGLIFLOZINO L-PIROGLUTAMO RUGSTIS; REGISTRATION NO/DATE: EU/1/18/1267 20180321 |
| 2334687 | CA 2018 00025 | Denmark | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
