FDA Orange Book
Is there a generic for Steglatro?
Steglatro contains ertugliflozin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Steglatro (ertugliflozin). The Orange Book shows its last listed patent expires December 19, 2031.
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Steglatro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 15MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 209803, held by MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Steglatro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8080580 | December 19, 2031 | Drug substance, Drug product | U-2214 | 209803 |
Steglatro NDC codes
Questions
Is there a generic for Steglatro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Steglatro (ertugliflozin). The Orange Book shows its last listed patent expires December 19, 2031.
What is the generic name for Steglatro?
The active ingredient in Steglatro is ertugliflozin, per the FDA Orange Book.
When does the Steglatro patent expire?
The last patent listed for Steglatro in the Orange Book expires December 19, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.