Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Teva
US Army
Merck
Federal Trade Commission
Fuji
Medtronic
McKinsey
Cipla
QuintilesIMS

Generated: September 23, 2018

DrugPatentWatch Database Preview

TRESIBA Drug Profile

« Back to Dashboard

Which patents cover Tresiba, and what generic alternatives are available?

Tresiba is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are fourteen patents protecting this drug.

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.

Drug patent expirations by year for TRESIBA
Generic Entry Opportunity Date for TRESIBA
Generic Entry Date for TRESIBA*:
Constraining patent/regulatory exclusivity:
NDA:
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 TRESIBA
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for TRESIBA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Supplementary Protection Certificates for TRESIBA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
226 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
00597 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
60026 Netherlands ➤ Sign Up PRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
0130014 00133 Estonia ➤ Sign Up PRODUCT NAME: DEGLUDEKINSULIIN/ASPARTINSULIIN;REG NO/DATE: K(2013)368 (LOPLIK) 23.01.2013
90067-4 Sweden ➤ Sign Up PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
C0035 France ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
2017020 Lithuania ➤ Sign Up PRODUCT NAME: INSULINAS GLARGINAS + LIKSIZENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

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

Serving hundreds of leading biopharmaceutical companies globally:

Teva
US Army
Merck
Federal Trade Commission
Fuji
Medtronic
McKinsey
Cipla
QuintilesIMS

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.