FDA Orange Book
Is there a generic for Ogsiveo?
Ogsiveo contains nirogacestat. 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 Ogsiveo (nirogacestat). The Orange Book shows its last listed patent expires May 19, 2043 and its last listed exclusivity ends November 27, 2030.
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Ogsiveo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 50MG BASE | Discontinued | None | 0 | None |
NDA 217677, held by SPRINGWORKS THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ogsiveo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7795447 | August 18, 2030 | Drug substance | None | 217677 |
| 10941118 | August 9, 2039 | Drug substance | U-3754 | 217677 |
| 10710966 | August 9, 2039 | Drug substance | U-3754 | 217677 |
| 11845732 | August 9, 2039 | Drug substance | U-3754 | 217677 |
| 11884635 | August 9, 2039 | Drug product | None | 217677 |
| 11884634 | August 9, 2039 | Drug product | None | 217677 |
| 11905255 | August 9, 2039 | Drug product | None | 217677 |
| 11820748 | August 9, 2039 | Drug product | None | 217677 |
| 10590087 | August 9, 2039 | Drug substance | None | 217677 |
| 12297177 | August 9, 2039 | Drug product | None | 217677 |
| 12116347 | August 9, 2039 | Drug product | None | 217677 |
| 11612588 | July 8, 2042 | Drug product | U-3754 | 217677 |
| 12247012 | July 8, 2042 | Drug product | None | 217677 |
| 12110277 | July 8, 2042 | Drug product | None | 217677 |
| 12234210 | July 8, 2042 | Drug product | None | 217677 |
| 12599587 | July 8, 2042 | Drug product | None | 217677 |
| 11504354 | July 8, 2042 | Drug product | None | 217677 |
| 11807611 | September 8, 2042 | Drug product | U-3754 | 217677 |
| 11844780 | September 8, 2042 | Drug product | U-3754 | 217677 |
| 12138246 | May 19, 2043 | Method of use | U-3754 | 217677 |
| 12011435 | May 19, 2043 | Method of use | U-3754 | 217677 |
| 12011434 | May 19, 2043 | Method of use | U-3754 | 217677 |
| 11925620 | May 19, 2043 | Method of use | U-3754 | 217677 |
| 11925619 | May 19, 2043 | Method of use | U-3754 | 217677 |
| 11938116 | May 19, 2043 | Method of use | U-3754 | 217677 |
| 11957662 | May 19, 2043 | Method of use | U-3754 | 217677 |
| 11951096 | May 19, 2043 | Method of use | U-3754 | 217677 |
| 12036207 | May 19, 2043 | Method of use | U-3754 | 217677 |
| 11872211 | May 19, 2043 | Method of use | U-3754 | 217677 |
Ogsiveo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 27, 2028 | 217677 |
| ODE-452 | Orphan drug exclusivity | November 27, 2030 | 217677 |
| ODE* | See the Orange Book exclusivity code list | November 27, 2030 | 217677 |
Ogsiveo NDC codes
Questions
Is there a generic for Ogsiveo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ogsiveo (nirogacestat). The Orange Book shows its last listed patent expires May 19, 2043 and its last listed exclusivity ends November 27, 2030.
What is the generic name for Ogsiveo?
The active ingredient in Ogsiveo is nirogacestat, per the FDA Orange Book.
When does the Ogsiveo patent expire?
The last patent listed for Ogsiveo in the Orange Book expires May 19, 2043. 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.