FDA Orange Book
Is there a generic for Attruby?
Attruby contains acoramidis. 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 Attruby (acoramidis). The Orange Book shows its last listed patent expires August 16, 2039 and its last listed exclusivity ends November 22, 2031.
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Attruby products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 356MG BASE | Marketed (Rx) | None | 0 | None |
NDA 216540, held by BRIDGEBIO PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Attruby patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9169214 | May 5, 2031 | Drug product | U-4046 | 216540 |
| 9913826 | May 5, 2031 | Method of use | U-4046 | 216540 |
| 10842777 | May 5, 2031 | Method of use | U-4046 | 216540 |
| 10398681 | May 5, 2031 | Drug product | None | 216540 |
| 9642838 | May 5, 2031 | Drug substance, Drug product | None | 216540 |
| 8877795 | May 5, 2031 | Drug product | None | 216540 |
| 11919865 | February 16, 2038 | Method of use | U-4046 | 216540 |
| 10513497 | February 16, 2038 | Drug substance | None | 216540 |
| 11058668 | March 22, 2039 | Method of use | U-4046 | 216540 |
| 12070449 | March 22, 2039 | Method of use | U-4046 | 216540 |
| 12005043 | August 16, 2039 | Drug product | U-4046 | 216540 |
| 12539290 | August 16, 2039 | Drug product | None | 216540 |
| 11260047 | August 16, 2039 | Drug product | None | 216540 |
Attruby exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 22, 2029 | 216540 |
| ODE-506 | Orphan drug exclusivity | November 22, 2031 | 216540 |
Attruby NDC codes
Questions
Is there a generic for Attruby?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Attruby (acoramidis). The Orange Book shows its last listed patent expires August 16, 2039 and its last listed exclusivity ends November 22, 2031.
What is the generic name for Attruby?
The active ingredient in Attruby is acoramidis, per the FDA Orange Book.
When does the Attruby patent expire?
The last patent listed for Attruby in the Orange Book expires August 16, 2039. 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.