Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: September 19, 2019

DrugPatentWatch Database Preview

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.
Summary for 209964
Tradename:CORLANOR
Applicant:Amgen Inc
Ingredient:ivabradine
Patents:4
Generic Entry Opportunity Date for 209964
Generic Entry Date for 209964*:
Constraining patent/regulatory exclusivity:
PEDIATRIC 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
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:RXDosage:SOLUTION;ORALStrength5MG/5ML (1MG/ML)
Approval Date:Apr 22, 2019TE: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:Apr 15, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Apr 22, 2022
Regulatory Exclusivity Use:NEW PRODUCT

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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 verifification 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.