FDA Orange Book
Is there a generic for Dawnzera (autoinjector)?
Dawnzera (autoinjector) contains donidalorsen. 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 Dawnzera (autoinjector) (donidalorsen). The Orange Book shows its last listed patent expires May 1, 2035 and its last listed exclusivity ends August 21, 2032.
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Dawnzera (autoinjector) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | Marketed (Rx) | None | 0 | None |
NDA 219407, held by IONIS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Dawnzera (autoinjector) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9315811 | October 21, 2032 | Method of use | U-3010 | 219407 |
| 9127276 | May 1, 2034 | Drug substance | None | 219407 |
| 9181549 | May 1, 2034 | Drug substance | None | 219407 |
| 9670492 | August 28, 2034 | Drug substance | None | 219407 |
| 10294477 | May 1, 2035 | Drug substance, Drug product | U-3010 | 219407 |
Dawnzera (autoinjector) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-550 | Orphan drug exclusivity | August 21, 2032 | 219407 |
Dawnzera (autoinjector) NDC codes
Questions
Is there a generic for Dawnzera (autoinjector)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Dawnzera (autoinjector) (donidalorsen). The Orange Book shows its last listed patent expires May 1, 2035 and its last listed exclusivity ends August 21, 2032.
What is the generic name for Dawnzera (autoinjector)?
The active ingredient in Dawnzera (autoinjector) is donidalorsen, per the FDA Orange Book.
When does the Dawnzera (autoinjector) patent expire?
The last patent listed for Dawnzera (autoinjector) in the Orange Book expires May 1, 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.