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Last Updated: April 19, 2024

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 four 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:4
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022341
Generic Entry Date for 022341*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*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: 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength18MG/3ML (6MG/ML)
Approval Date:Jan 25, 2010TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Nov 23, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Feb 13, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Mar 23, 2033Product Flag?Substance Flag?Delist Request?Y

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

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