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Last Updated: July 22, 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. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the liraglutide profile page.
Summary for 022341
Tradename:VICTOZA
Applicant:Novo Nordisk Inc
Ingredient:liraglutide
Patents:4
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
Suppliers and Packaging for NDA: 022341
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VICTOZA liraglutide 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 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:⤷  Sign UpPatent Expiration:Nov 23, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Feb 13, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent 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 SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 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.