ERTUGLIFLOZIN Drug Patent Profile
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When do Ertugliflozin patents expire, and when can generic versions of Ertugliflozin launch?
Ertugliflozin is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA.
The generic ingredient in ERTUGLIFLOZIN is ertugliflozin. Two suppliers are listed for this compound. Additional details are available on the ertugliflozin profile page.
Summary for ERTUGLIFLOZIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 38 |
| Patent Applications: | 76 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ERTUGLIFLOZIN |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | ERTUGLIFLOZIN | ertugliflozin | TABLET;ORAL | 216947-001 | Jul 13, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma Ltd | ERTUGLIFLOZIN | ertugliflozin | TABLET;ORAL | 216947-002 | Jul 13, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
