FDA Orange Book
Is there a generic for Agamree?
Agamree contains vamorolone. 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 Agamree (vamorolone). The Orange Book shows its last listed patent expires July 16, 2040 and its last listed exclusivity ends October 26, 2030.
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Agamree products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 40MG/ML | Marketed (Rx) | None | 0 | None |
NDA 215239, held by CATALYST PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Agamree patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10857161 | May 28, 2029 | Drug product | U-3747 | 215239 |
| 11833159 | May 28, 2029 | Drug product | None | 215239 |
| 11690853 | March 7, 2033 | Method of use | U-3747 | 215239 |
| 8334279 | April 23, 2034 | Method of use | U-3747 | 215239 |
| 12201639 | March 17, 2040 | Drug substance, Drug product | U-3747 | 215239 |
| 11471471 | March 17, 2040 | Method of use | U-3747 | 215239 |
| 11382922 | July 16, 2040 | Drug substance, Drug product | None | 215239 |
Agamree exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | October 26, 2028 | 215239 |
| ODE-450 | Orphan drug exclusivity | October 26, 2030 | 215239 |
Questions
Is there a generic for Agamree?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Agamree (vamorolone). The Orange Book shows its last listed patent expires July 16, 2040 and its last listed exclusivity ends October 26, 2030.
What is the generic name for Agamree?
The active ingredient in Agamree is vamorolone, per the FDA Orange Book.
When does the Agamree patent expire?
The last patent listed for Agamree in the Orange Book expires July 16, 2040. 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.