FDA Orange Book
Is there a generic for Ekterly?
Ekterly contains sebetralstat. 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 Ekterly (sebetralstat). The Orange Book shows its last listed patent expires January 26, 2039 and its last listed exclusivity ends July 3, 2032.
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Ekterly products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 300MG | Marketed (Rx) | None | 0 | None |
NDA 219301, held by KALVISTA PHARMACEUTICALS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ekterly patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11198691 | November 26, 2035 | Method of use | U-4223 | 219301 |
| 11084809 | November 26, 2035 | Drug substance, Drug product | U-4223 | 219301 |
| 10611758 | November 26, 2035 | Method of use | U-4223 | 219301 |
| 10364238 | November 26, 2035 | Drug substance, Drug product | None | 219301 |
| 11001578 | November 26, 2035 | Drug substance, Drug product | None | 219301 |
| 11739068 | June 23, 2037 | Method of use | U-4223 | 219301 |
| 11230537 | December 25, 2037 | Drug substance, Drug product | None | 219301 |
| 11234939 | January 26, 2039 | Drug product | U-4223 | 219301 |
Ekterly exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 3, 2030 | 219301 |
| ODE-534 | Orphan drug exclusivity | July 3, 2032 | 219301 |
Ekterly NDC codes
Questions
Is there a generic for Ekterly?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ekterly (sebetralstat). The Orange Book shows its last listed patent expires January 26, 2039 and its last listed exclusivity ends July 3, 2032.
What is the generic name for Ekterly?
The active ingredient in Ekterly is sebetralstat, per the FDA Orange Book.
When does the Ekterly patent expire?
The last patent listed for Ekterly in the Orange Book expires January 26, 2039. 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.