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Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203314

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NDA 203314 describes TRESIBA, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the TRESIBA profile page.

The generic ingredient in TRESIBA is insulin degludec. There are thirty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin degludec profile page.
Summary for 203314
Applicant:Novo Nordisk Inc
Ingredient:insulin degludec
Pharmacology for NDA: 203314
Suppliers and Packaging for NDA: 203314
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314 NDA Novo Nordisk 0169-2550 N 0169-2550-13
TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314 NDA Novo Nordisk 0169-2550 N 0169-2550-97

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Sep 25, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 25, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 16, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent Expiration:Jan 2, 2022Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Argus Health

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.