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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Merck
Fish and Richardson
Farmers Insurance
US Army
Harvard Business School
Boehringer Ingelheim
Fuji
Dow

Generated: June 17, 2018

DrugPatentWatch Database Preview

TRESIBA Drug Profile

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When do Tresiba patents expire, and what generic alternatives are available?

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

This drug has one hundred and thirty-five patent family members in twenty-three countries.

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 TRESIBA
Drug patent expirations by year for TRESIBA
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 203314-001 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 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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for TRESIBA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,828,923 Insulin derivatives ➤ Sign Up
8,096,978 Automatic injection device with a top release mechanism ➤ Sign Up
7,686,786 Dial-down mechanism for wind-up pen ➤ Sign Up
8,357,120 Injection device with torsion spring and rotatable display ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for TRESIBA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
91020-8 0090020-9 Sweden ➤ Sign Up PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
C/GB05/024 United Kingdom ➤ Sign Up PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
2014000114 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
C0085 France ➤ Sign Up PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Julphar
Dow
Johnson and Johnson
Argus Health
UBS
McKesson
Cerilliant
Teva

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