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Serving leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Daiichi Sankyo
Medtronic
Colorcon
Cerilliant
Harvard Business School
QuintilesIMS
Julphar
Novartis

Generated: November 19, 2017

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 nine 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:
1
Applicant:
1
Ingredient:
1
Patents:9
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength18MG/3ML (6MG/ML)
Approval Date:Jan 25, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 25, 2020
Regulatory Exclusivity Use:
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
Patent:► SubscribePatent Expiration:Jan 28, 2019Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022341

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010► Subscribe► Subscribe
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
UBS
Chinese Patent Office
Mallinckrodt
AstraZeneca
Argus Health
Farmers Insurance
McKinsey
Cerilliant

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.

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