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Last Updated: January 28, 2020

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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 and is included in one NDA. There are nineteen patents protecting this drug.

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

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.

US ANDA Litigation and Generic Entry Outlook for Tresiba

Tresiba was eligible for patent challenges on September 25, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 28, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for TRESIBA
Drug Prices for TRESIBA

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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.

Recent Clinical Trials for TRESIBA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sansum Diabetes Research InstitutePhase 4
LMC Diabetes & Endocrinology Ltd.Phase 4
Emory UniversityPhase 4

See all TRESIBA clinical trials

Recent Litigation for TRESIBA

Identify potential future generic entrants

District Court Litigation
Case NameDate
SMITH v. NOVO NORDISK INC.2016-08-08

See all TRESIBA litigation

Pharmacology for TRESIBA
Drug ClassInsulin Analog
Synonyms for TRESIBA
(1A-21A),(1B-29B)-Insulin (human), 29B-(N6-(N-(15-carboxy-1-oxopentadecyl)-L-gamma- glutamyl)-L-lysine)-
54Q18076QB
844439-96-9
886983-20-6
B29N(epsilon)-omega-carboxypentadecanoyl-gamma-L-glutamyl desB30 human insulin
Degludec
Insulin degludec
Insulin degludec [USAN:INN]
NN 1250
NN1250
UNII-54Q18076QB

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

Supplementary Protection Certificates for TRESIBA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 C300596 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
2107069 SPC/GB13/037 United Kingdom   Start Trial PRODUCT NAME: INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, COMPLEXES, OR SALTS THEREOF; REGISTERED: UK EU/1/12/807/001 20130123; UK EU/1/12/807/004 20130123; UK EU/1/12/807/005 20130123; UK EU/1/12/807/007 20130123; UK EU/1/12/807/008 20130123; UK EU/1/12/807/009 20130123; UK EU/1/12/807/012 20130123; UK EU/1/12/807/013 20130123; UK EU/1/12/807/015 20130123
2107069 C 2013 019 Romania   Start Trial PRODUCT NAME: INSULINA DEGLUDECIN TOATE FORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001; DATE OF FIRST AUTHORISATION IN EEA: 20130121
2340033 122017000040 Germany   Start Trial PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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