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. One supplier is listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.
The generic ingredient in CORLANOR is ivabradine hydrochloride. There are nine drug master file entries for this compound. One supplier is 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209964
Generic Entry Date for 209964*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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: | RX | 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: | ⤷ Try a Trial | 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 | ||||||||
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