FDA Orange Book
Is there a generic for Rivfloza?
Rivfloza contains nedosiran. 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 Rivfloza (nedosiran). The Orange Book shows its last listed patent expires October 12, 2038 and its last listed exclusivity ends March 27, 2032.
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Rivfloza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, injection | EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, injection | EQ 160MG BASE/ML (EQ 160MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, injection | EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 215842, held by NOVO NORDISK INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rivfloza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11359203 | October 9, 2035 | Drug substance, Drug product | U-3709 | 215842 |
| 10738311 | October 9, 2035 | Drug substance, Drug product | U-3709 | 215842 |
| 10351854 | October 9, 2035 | Drug substance, Drug product | None | 215842 |
| 11053502 | October 29, 2035 | Drug substance, Drug product | None | 215842 |
| 11661604 | October 12, 2038 | Drug substance, Drug product | U-3709 | 215842 |
| 11286488 | October 12, 2038 | Drug substance, Drug product | U-3709 | 215842 |
Rivfloza exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | March 27, 2028 | 215842 |
| NCE | New chemical entity | September 29, 2028 | 215842 |
| ODE-443 | Orphan drug exclusivity | September 29, 2030 | 215842 |
| ODE-531 | Orphan drug exclusivity | March 27, 2032 | 215842 |
Rivfloza NDC codes
Questions
Is there a generic for Rivfloza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rivfloza (nedosiran). The Orange Book shows its last listed patent expires October 12, 2038 and its last listed exclusivity ends March 27, 2032.
What is the generic name for Rivfloza?
The active ingredient in Rivfloza is nedosiran, per the FDA Orange Book.
When does the Rivfloza patent expire?
The last patent listed for Rivfloza in the Orange Book expires October 12, 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.