grepcent public filings, reorganized for comparison

CORLANOR — FDA application NDA206143

Application NDA206143 · type NDA · FDA status: approved · original approval 2015-04-15

Listed sponsor: AMGEN INC · AMGN 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
001CORLANORIVABRADINE HYDROCHLORIDETABLETORALEQ 5MG BASEDiscontinuednot listedYes
002CORLANORIVABRADINE HYDROCHLORIDETABLETORALEQ 7.5MG BASEDiscontinuednot 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 7361649001listed patent expiry date: 2026-02-22drug substance, drug product, U-1694
Patent 7361649002listed patent expiry date: 2026-02-22drug substance, drug product, U-1694
Patent 7361650001listed patent expiry date: 2026-02-22drug substance, drug product, U-1694
Patent 7361650002listed patent expiry date: 2026-02-22drug substance, drug product, U-1694
Patent 7879842001listed patent expiry date: 2026-02-22drug substance, drug product, U-1694
Patent 7879842002listed patent expiry date: 2026-02-22drug substance, drug product, U-1694
Patent 7361649001listed patent expiry date: 2026-08-22pediatric extension
Patent 7361649002listed patent expiry date: 2026-08-22pediatric extension
Patent 7361650001listed patent expiry date: 2026-08-22pediatric extension
Patent 7361650002listed patent expiry date: 2026-08-22pediatric extension
Patent 7879842001listed patent expiry date: 2026-08-22pediatric extension
Patent 7879842002listed patent expiry date: 2026-08-22pediatric extension
Patent 7867996001listed patent expiry date: 2026-12-12drug substance, drug product, U-1694
Patent 7867996002listed patent expiry date: 2026-12-12drug substance, drug product, U-1694
Patent 7867996001listed patent expiry date: 2027-06-12pediatric extension
Patent 7867996002listed patent expiry date: 2027-06-12pediatric extension
NDA206143 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA206143 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA206143 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 marker0.001.002.002015-04-151.002026-02-221.002026-08-221.002026-12-121.002027-06-121.00

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: Large-cap biopharma

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.