FDA Orange Book
Is there a generic for Steglujan?
Steglujan contains ertugliflozin and sitagliptin. 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 Steglujan (ertugliflozin and sitagliptin). The Orange Book shows its last listed patent expires December 19, 2031.
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Steglujan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 15MG;EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | 5MG;EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
NDA 209805, 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.
Steglujan patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7326708 | November 24, 2026 | Drug substance, Drug product | U-2214 | 209805 |
| 7326708*PED | May 24, 2027 | Method of use | None | 209805 |
| 9439901 | October 21, 2030 | Method of use | U-2214 | 209805 |
| 9308204 | October 21, 2030 | Drug product | None | 209805 |
| 8080580 | December 19, 2031 | Drug substance, Drug product | U-2214 | 209805 |
Steglujan NDC codes
Questions
Is there a generic for Steglujan?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Steglujan (ertugliflozin and sitagliptin). The Orange Book shows its last listed patent expires December 19, 2031.
What is the generic name for Steglujan?
The active ingredient in Steglujan is ertugliflozin and sitagliptin, per the FDA Orange Book.
When does the Steglujan patent expire?
The last patent listed for Steglujan 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.