# ATTRUBY — FDA application NDA216540

Informational only - not investment advice.

Application NDA216540 · type NDA · FDA status: approved · original approval 2024-11-22

Listed sponsor: BRIDGEBIO PHARMA · [BBIO company profile](/company/BBIO/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | ATTRUBY | ACORAMIDIS HYDROCHLORIDE | TABLET | ORAL | EQ 356MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10398681, product 001; listed patent expiry date: 2031-05-05.
- Patent 10842777, product 001; listed patent expiry date: 2031-05-05.
- Patent 8877795, product 001; listed patent expiry date: 2031-05-05.
- Patent 9169214, product 001; listed patent expiry date: 2031-05-05.
- Patent 9642838, product 001; listed patent expiry date: 2031-05-05.
- Patent 9913826, product 001; listed patent expiry date: 2031-05-05.
- Patent 10513497, product 001; listed patent expiry date: 2038-02-16.
- Patent 11919865, product 001; listed patent expiry date: 2038-02-16.
- Patent 11058668, product 001; listed patent expiry date: 2039-03-22.
- Patent 12070449, product 001; listed patent expiry date: 2039-03-22.
- Patent 11260047, product 001; listed patent expiry date: 2039-08-16.
- Patent 12005043, product 001; listed patent expiry date: 2039-08-16.
- Patent 12539290, product 001; listed patent expiry date: 2039-08-16.
- Exclusivity NCE, product 001; listed exclusivity date: 2029-11-22.
- Exclusivity ODE-506, product 001; listed exclusivity date: 2031-11-22.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- ACORAMIDIS HYDROCHLORIDE · UNII VY9C88C2NV · [lmmol compound MGFZEARHINUOMX-UHFFFAOYSA-N](https://lmmol.com/compound/MGFZEARHINUOMX-UHFFFAOYSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/BBIO/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA216540. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.
