FDA Orange Book
Is there a generic for Zilbrysq?
Zilbrysq contains zilucoplan. 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 Zilbrysq (zilucoplan). The Orange Book shows its last listed patent expires June 12, 2035 and its last listed exclusivity ends October 17, 2030.
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Zilbrysq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | Marketed (Rx) | None | 0 | None |
NDA 216834, held by UCB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zilbrysq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11752190 | June 12, 2035 | Drug product | U-3735 | 216834 |
| 11014965 | June 12, 2035 | Drug substance | U-3735 | 216834 |
| 10435438 | June 12, 2035 | Drug substance | U-3735 | 216834 |
| 10208089 | June 12, 2035 | Drug substance | U-3735 | 216834 |
| 10106579 | June 12, 2035 | Drug substance, Drug product | U-3735 | 216834 |
| 10835574 | June 12, 2035 | Drug product | None | 216834 |
| 11535650 | June 12, 2035 | Drug product | None | 216834 |
| 10562934 | June 12, 2035 | Drug substance | None | 216834 |
| 11965040 | June 12, 2035 | Drug product | None | 216834 |
Zilbrysq exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | October 17, 2028 | 216834 |
| ODE-446 | Orphan drug exclusivity | October 17, 2030 | 216834 |
Zilbrysq NDC codes
Questions
Is there a generic for Zilbrysq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zilbrysq (zilucoplan). The Orange Book shows its last listed patent expires June 12, 2035 and its last listed exclusivity ends October 17, 2030.
What is the generic name for Zilbrysq?
The active ingredient in Zilbrysq is zilucoplan, per the FDA Orange Book.
When does the Zilbrysq patent expire?
The last patent listed for Zilbrysq in the Orange Book expires June 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.