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Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 022341


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NDA 022341 describes VICTOZA, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VICTOZA profile page.

The generic ingredient in VICTOZA is liraglutide recombinant. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the liraglutide recombinant profile page.
Summary for 022341
Tradename:VICTOZA
Applicant:Novo Nordisk Inc
Ingredient:liraglutide recombinant
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 022341
Medical Subject Heading (MeSH) Categories for 022341
Suppliers and Packaging for NDA: 022341
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341 NDA Novo Nordisk 0169-4060 0169-4060-12 2 SYRINGE, PLASTIC in 1 CARTON (0169-4060-12) > 3 mL in 1 SYRINGE, PLASTIC
VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341 NDA Novo Nordisk 0169-4060 0169-4060-13 3 SYRINGE, PLASTIC in 1 CARTON (0169-4060-13) > 3 mL in 1 SYRINGE, PLASTIC
Paragraph IV (Patent) Challenges for 022341
Tradename Dosage Ingredient NDA Submissiondate
VICTOZA SOLUTION;SUBCUTANEOUS liraglutide recombinant 022341 2016-12-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength18MG/3ML (6MG/ML)
Approval Date:Jan 25, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 17, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Dec 17, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Aug 25, 2020
Regulatory Exclusivity Use:REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE

Expired US Patents for NDA 022341

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010   Start Trial   Start Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010   Start Trial   Start Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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