FDA Orange Book
Is there a generic for Inpefa?
Inpefa contains sotagliflozin. 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 Inpefa (sotagliflozin). The Orange Book shows its last listed patent expires October 7, 2030 and its last listed exclusivity ends May 26, 2028.
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Inpefa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 400MG | Marketed (Rx) | None | 0 | None |
NDA 216203, held by LEXICON PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Inpefa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7781577 | May 4, 2028 | Drug substance, Drug product | U-3628 | 216203 |
| 8476413 | May 29, 2028 | Drug substance, Drug product | U-3628 | 216203 |
| 8217156 | October 7, 2030 | Drug substance, Drug product | None | 216203 |
Inpefa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 26, 2028 | 216203 |
Inpefa NDC codes
Questions
Is there a generic for Inpefa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Inpefa (sotagliflozin). The Orange Book shows its last listed patent expires October 7, 2030 and its last listed exclusivity ends May 26, 2028.
What is the generic name for Inpefa?
The active ingredient in Inpefa is sotagliflozin, per the FDA Orange Book.
When does the Inpefa patent expire?
The last patent listed for Inpefa in the Orange Book expires October 7, 2030. 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.