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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Cerilliant
Johnson and Johnson
Daiichi Sankyo
Merck
Federal Trade Commission
Moodys
Queensland Health
Chubb

Generated: April 19, 2018

DrugPatentWatch Database Preview

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 one supplier. There are seven 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 six drug master file entries for this compound. One supplier is 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:7
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 N 0169-4060-13
VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341 NDA Novo Nordisk 0169-4060 N 0169-4060-12

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:Apr 22, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING DESCRIBING TRIAL NN2211-3916, A TRIAL EVALUATING THE SAFETY AND EFFICACY OF LIRAGLUTIDE IN SUBJECTS WITH TYPE 2 DIABETES AND MODERATE RENAL IMPAIRMENT
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
Patent:➤ Try a Free TrialPatent Expiration:Jan 28, 2019Product Flag?YSubstance Flag?Delist Request?

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

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Express Scripts
Julphar
McKinsey
Medtronic
US Army
Cerilliant
Accenture
Fuji

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