Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
Healthtrust
McKesson
US Department of Justice
Accenture
Medtronic
Harvard Business School
Chubb

Generated: January 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203314

« Back to Dashboard

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

The generic ingredient in TRESIBA is insulin degludec. There are forty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the insulin degludec profile page.
Summary for 203314
Tradename:TRESIBA
Applicant:Novo Nordisk Inc
Ingredient:insulin degludec
Patents:14
Generic Entry Opportunity Date for 203314
Generic Entry Date for 203314*:
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: 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 0169-2550-13 3 SYRINGE, PLASTIC in 1 CARTON (0169-2550-13) > 3 mL in 1 SYRINGE, PLASTIC
TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314 NDA Novo Nordisk 0169-2550 0169-2550-97 1 SYRINGE, PLASTIC in 1 CARTON (0169-2550-97) > 3 mL in 1 SYRINGE, PLASTIC

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:➤ Sign UpPatent Expiration:Jan 2, 2022Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Army
Daiichi Sankyo
Accenture
Mallinckrodt
Chinese Patent Office
Citi
Moodys
Covington

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.