FDA Orange Book
Is there a generic for Amvuttra?
Amvuttra contains vutrisiran. 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 Amvuttra (vutrisiran). The Orange Book shows its last listed patent expires July 28, 2036 and its last listed exclusivity ends March 20, 2032.
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Amvuttra 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 215515, held by ALNYLAM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Amvuttra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10131907 | August 24, 2028 | Drug substance, Drug product | U-3396 | 215515 |
| 9370581 | December 4, 2028 | Drug substance, Drug product | U-3396 | 215515 |
| 8828956 | December 4, 2028 | Drug substance, Drug product | U-3396 | 215515 |
| 10806791 | December 4, 2028 | Drug substance | None | 215515 |
| 8106022 | December 12, 2029 | Drug substance, Drug product | U-3396 | 215515 |
| 9399775 | November 16, 2032 | Drug substance, Drug product | U-3396 | 215515 |
| 10570391 | November 16, 2032 | Drug substance, Drug product | U-3396 | 215515 |
| 11401517 | August 14, 2035 | Drug substance, Drug product | U-3396 | 215515 |
| 10612024 | August 14, 2035 | Drug substance, Drug product | U-3396 | 215515 |
| 11286486 | July 28, 2036 | Drug substance, Drug product | U-3396 | 215515 |
| 10683501 | July 28, 2036 | Drug substance, Drug product | U-3396 | 215515 |
| 10208307 | July 28, 2036 | Drug substance, Drug product | U-3396 | 215515 |
| 12049628 | July 28, 2036 | Drug substance, Drug product | U-3396 | 215515 |
Amvuttra exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 13, 2027 | 215515 |
| I-964 | New indication | March 20, 2028 | 215515 |
| ODE-212 | Orphan drug exclusivity | June 13, 2029 | 215515 |
| ODE-527 | Orphan drug exclusivity | March 20, 2032 | 215515 |
Amvuttra NDC codes
Questions
Is there a generic for Amvuttra?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Amvuttra (vutrisiran). The Orange Book shows its last listed patent expires July 28, 2036 and its last listed exclusivity ends March 20, 2032.
What is the generic name for Amvuttra?
The active ingredient in Amvuttra is vutrisiran, per the FDA Orange Book.
When does the Amvuttra patent expire?
The last patent listed for Amvuttra in the Orange Book expires July 28, 2036. 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.