Last Updated: May 4, 2026

Details for New Drug Application (NDA): 209964

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NDA 209964 describes CORLANOR, which is a drug marketed by Amgen Inc and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the CORLANOR profile page.

The generic ingredient in CORLANOR is ivabradine hydrochloride. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.

Summary for 209964

Tradename:	CORLANOR
Applicant:	Amgen Inc
Ingredient:	ivabradine
Patents:	4

Pharmacology for NDA: 209964

Mechanism of Action	Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists

Suppliers and Packaging for NDA: 209964

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CORLANOR	ivabradine	SOLUTION;ORAL	209964	NDA	Amgen Inc	55513-813	55513-813-28	28 AMPULE in 1 CARTON (55513-813-28) / 5 mL in 1 AMPULE (55513-813-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML (1MG/ML)
Approval Date:	Apr 22, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 22, 2026
Regulatory Exclusivity Use:	INDICATED FOR THE TREATMENT OF STABLE SYMPTOMATIC HEART FAILURE DUE TO DILATED CARDIOMYOPATHY (DCM) IN PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER, WHO ARE IN SINUS RHYTHM WITH AN ELEVATED HEART RATE
Regulatory Exclusivity Expiration:	Oct 22, 2026
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	7,361,649	Patent Expiration:	Feb 22, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE

Expired US Patents for NDA 209964

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019	7,361,650	⤷ Start Trial
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019	7,879,842	⤷ Start Trial
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019	7,361,649	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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