Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Last Updated: October 20, 2019

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

This drug has one hundred and seventy-five 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.

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

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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 203314-003 Nov 21, 2018 RX No No   Start Trial   Start Trial Y 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 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
0705275 SPC/GB00/027 United Kingdom   Start Trial PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
0368187 SZ 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
2209800 14C0085 France   Start Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
0368187 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Merck
McKinsey
Dow
AstraZeneca

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.