FDA Orange Book
Is there a generic for Redemplo?
Redemplo contains plozasiran. 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 Redemplo (plozasiran). The Orange Book shows its last listed patent expires September 10, 2038 and its last listed exclusivity ends November 18, 2032.
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Redemplo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) | Marketed (Rx) | None | 0 | None |
NDA 219947, held by ARROWHEAD PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Redemplo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10294474 | March 7, 2037 | Drug substance, Drug product | U-4360 | 219947 |
| 11174481 | March 7, 2037 | Drug substance, Drug product | None | 219947 |
| 12365899 | September 10, 2038 | Drug substance, Drug product | U-4360 | 219947 |
| 11214801 | September 10, 2038 | Drug substance, Drug product | U-4360 | 219947 |
| 10597657 | September 10, 2038 | Drug substance, Drug product | U-4360 | 219947 |
Redemplo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-541 | Orphan drug exclusivity | November 18, 2032 | 219947 |
Redemplo NDC codes
Questions
Is there a generic for Redemplo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Redemplo (plozasiran). The Orange Book shows its last listed patent expires September 10, 2038 and its last listed exclusivity ends November 18, 2032.
What is the generic name for Redemplo?
The active ingredient in Redemplo is plozasiran, per the FDA Orange Book.
When does the Redemplo patent expire?
The last patent listed for Redemplo in the Orange Book expires September 10, 2038. 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.