CORLANOR — FDA application NDA209964

Application NDA209964 · type NDA · FDA status: approved · original approval 2019-04-22

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

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	CORLANOR	IVABRADINE	SOLUTION	ORAL	5MG/5ML (1MG/ML)	Discontinued	not listed	Yes

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.

Listing	Product	Descriptive date	Flags/code
Patent 7361649	001	listed patent expiry date: 2026-02-22	drug substance, drug product, U-1694
Patent 7361650	001	listed patent expiry date: 2026-02-22	drug substance, drug product, U-1694
Patent 7879842	001	listed patent expiry date: 2026-02-22	drug substance, drug product, U-1694
Patent 7867996	001	listed patent expiry date: 2026-12-12	drug substance, drug product, U-1694
Exclusivity ODE-234	001	listed exclusivity date: 2026-04-22	FDA code as listed
Exclusivity PED	001	listed exclusivity date: 2026-10-22	FDA code as listed

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

IVABRADINE HYDROCHLORIDE · UNII TP19837BZK · lmmol compound HLUKNZUABFFNQS-ZMBIFBSDSA-N · CHEMBL2145077

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

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.