FDA Orange Book
Is there a generic for Voxzogo?
Voxzogo contains vosoritide. 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 Voxzogo (vosoritide). The Orange Book shows its last listed patent expires July 11, 2042 and its last listed exclusivity ends October 20, 2030.
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Voxzogo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, subcutaneous | 0.4MG/VIAL | Marketed (Rx) | None | 0 | None |
| powder, subcutaneous | 0.56MG/VIAL | Marketed (Rx) | None | 0 | None |
| powder, subcutaneous | 1.2MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 214938, held by BIOMARIN PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Voxzogo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE48267 | May 20, 2030 | Method of use | U-3927 | 214938 |
| 8198242 | June 11, 2035 | Drug substance, Drug product | U-3927 | 214938 |
| 11911446 | August 1, 2036 | Method of use | U-3927 | 214938 |
| 11590204 | August 1, 2036 | Drug product | U-3927 | 214938 |
| 12514906 | August 1, 2036 | Drug product | U-3927 | 214938 |
| 10646550 | August 1, 2036 | Drug product | U-3927 | 214938 |
| 9907834 | August 1, 2036 | Drug product | None | 214938 |
| 12233106 | July 11, 2042 | Method of use | U-3927 | 214938 |
Voxzogo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | October 20, 2026 | 214938 |
| NCE | New chemical entity | November 19, 2026 | 214938 |
| ODE-387 | Orphan drug exclusivity | November 19, 2028 | 214938 |
| ODE-449 | Orphan drug exclusivity | October 20, 2030 | 214938 |
Questions
Is there a generic for Voxzogo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Voxzogo (vosoritide). The Orange Book shows its last listed patent expires July 11, 2042 and its last listed exclusivity ends October 20, 2030.
What is the generic name for Voxzogo?
The active ingredient in Voxzogo is vosoritide, per the FDA Orange Book.
When does the Voxzogo patent expire?
The last patent listed for Voxzogo in the Orange Book expires July 11, 2042. 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.