grepcent public filings, reorganized for comparison

ATTRUBY — FDA application NDA216540

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

Listed sponsor: BRIDGEBIO PHARMA · BBIO company profile · exact_unique

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

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001ATTRUBYACORAMIDIS HYDROCHLORIDETABLETORALEQ 356MG BASEPrescriptionnot listedYes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 10398681001listed patent expiry date: 2031-05-05drug product
Patent 10842777001listed patent expiry date: 2031-05-05U-4046
Patent 8877795001listed patent expiry date: 2031-05-05drug product
Patent 9169214001listed patent expiry date: 2031-05-05drug product, U-4046
Patent 9642838001listed patent expiry date: 2031-05-05drug substance, drug product
Patent 9913826001listed patent expiry date: 2031-05-05U-4046
Patent 10513497001listed patent expiry date: 2038-02-16drug substance
Patent 11919865001listed patent expiry date: 2038-02-16U-4046
Patent 11058668001listed patent expiry date: 2039-03-22U-4046
Patent 12070449001listed patent expiry date: 2039-03-22U-4046
Patent 11260047001listed patent expiry date: 2039-08-16drug product
Patent 12005043001listed patent expiry date: 2039-08-16drug product, U-4046
Patent 12539290001listed patent expiry date: 2039-08-16drug product
Exclusivity NCE001listed exclusivity date: 2029-11-22FDA code as listed
Exclusivity ODE-506001listed exclusivity date: 2031-11-22FDA code as listed
NDA216540 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA216540 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA216540 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002024-11-221.002029-11-221.002031-05-051.002031-11-221.002038-02-161.002039-03-221.002039-08-161.00

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

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

Related pages

Sponsor company · FDA-approved application index

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

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