FDA Orange Book · active-ingredient family
Ertugliflozin
Ertugliflozin: 1 brand, 3 generics; first approved Dec 19, 2017; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
1
Next patent expiry
Dec 19, 2031
in 5 yr 5 mo
Brand (NDA) products
Originator applications
- STEGLATRORLDMSD SUB MERCKNDA 20980320172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx — 15MG TABLET ORAL Rx —
Generic (ANDA) products (3)
Abbreviated applications
- ERTUGLIFLOZINHIKMAANDA 21684220252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — - ERTUGLIFLOZINHETERO LABS LTD VANDA 21707120242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — - ERTUGLIFLOZINAUROBINDO PHARMA LTDANDA 21694720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8080580 | in 5 yr 5 mo | SubstanceProductU-2214 |
Approval history
FDA approval span
First approval
8 yr 10 mo ago
Most recent approval
1 yr 7 mo ago
Approvals span 2017–2025 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Ertugliflozin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
