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Last Updated: August 14, 2020

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Details for New Drug Application (NDA): 206143

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NDA 206143 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.
Summary for 206143
Applicant:Amgen Inc
Ingredient:ivabradine hydrochloride
Generic Entry Opportunity Date for 206143
Generic Entry Date for 206143*:
Constraining patent/regulatory exclusivity:

*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: 206143
Suppliers and Packaging for NDA: 206143
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORLANOR ivabradine hydrochloride TABLET;ORAL 206143 NDA Amgen Inc 55513-800 55513-800-60 60 TABLET, FILM COATED in 1 BOTTLE (55513-800-60)
CORLANOR ivabradine hydrochloride TABLET;ORAL 206143 NDA Amgen Inc 55513-800 55513-800-80 180 TABLET, FILM COATED in 1 BOTTLE (55513-800-80)
Paragraph IV (Patent) Challenges for 206143
Tradename Dosage Ingredient NDA Submissiondate
CORLANOR TABLET;ORAL ivabradine hydrochloride 206143 2019-10-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Apr 15, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 15, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 15, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:  Start TrialPatent Expiration:Aug 22, 2026Product Flag?Substance Flag?Delist Request?Y

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.