FDA Orange Book
Is there a generic for Isturisa?
Isturisa contains osilodrostat. 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 Isturisa (osilodrostat). The Orange Book shows its last listed patent expires October 12, 2035 and its last listed exclusivity ends April 15, 2032.
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Isturisa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 1MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 212801, held by RECORDATI RARE DISEASES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Isturisa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8835646 | August 23, 2026 | Drug substance, Drug product | None | 212801 |
| 8609862 | January 13, 2031 | Method of use | U-4529 | 212801 |
| 9434754 | January 13, 2031 | Drug substance | None | 212801 |
| 8609862 | January 13, 2031 | Method of use | U-2770 | 212801 |
| 8314097 | May 20, 2033 | Drug substance, Drug product | None | 212801 |
| 10143680 | July 6, 2035 | Drug product | None | 212801 |
| 10709691 | October 12, 2035 | Method of use | U-4529 | 212801 |
| 10709691 | October 12, 2035 | Method of use | U-2770 | 212801 |
Isturisa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-286 | Orphan drug exclusivity | March 6, 2027 | 212801 |
| ODE-535 | Orphan drug exclusivity | April 15, 2032 | 212801 |
Isturisa NDC codes
Questions
Is there a generic for Isturisa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Isturisa (osilodrostat). The Orange Book shows its last listed patent expires October 12, 2035 and its last listed exclusivity ends April 15, 2032.
What is the generic name for Isturisa?
The active ingredient in Isturisa is osilodrostat, per the FDA Orange Book.
When does the Isturisa patent expire?
The last patent listed for Isturisa in the Orange Book expires October 12, 2035. 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.