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Last Updated: May 19, 2024

Insulin degludec - Biologic Drug Details


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Recent Clinical Trials for insulin degludec

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Sunshine Lake Pharma Co., Ltd.Phase 3
Hospital Universitario San IgnacioPhase 3
Xiangya Hospital of Central South UniversityPhase 3

See all insulin degludec clinical trials

Recent Litigation for insulin degludec

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Novo Nordisk, Inc. v. Mylan Pharmaceuticals, Inc.2022-08-08
In Re: Ozempic (Semaglutide) Patent Litigation2022-08-05
IN RE: Ozempic (Semaglutide) Patent Litigation2022-05-06

See all insulin degludec litigation

Pharmacology for insulin degludec
Established Pharmacologic ClassInsulin Analog
Chemical StructureInsulin
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for insulin degludec Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin degludec Derived from Company Disclosures

These patents were obtained from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 ⤷  Try a Trial 2021-01-05 Company disclosures
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 ⤷  Try a Trial 2023-08-05 Company disclosures
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 ⤷  Try a Trial 2024-10-21 Company disclosures
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 ⤷  Try a Trial 2021-01-05 Company disclosures
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 ⤷  Try a Trial 2024-10-21 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for insulin degludec Derived from Patent Text Search

These patents were obtained by searching patent claims

Supplementary Protection Certificates for insulin degludec

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
122013000062 Germany ⤷  Try a Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
C201300036 Spain ⤷  Try a Trial PRODUCT NAME: INSULINA DEGLUDEC/INSULINA ASPART; NATIONAL AUTHORISATION NUMBER: EU/1/12/806/001, 004, 005, 007, 008; DATE OF AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/806/001, 004, 005, 007, 008; DATE OF FIRST AUTHORISATION IN EEA: 20130121
92226 Luxembourg ⤷  Try a Trial PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/806/001,004,005,007,008 - RYZODEG 20130123
300596 Netherlands ⤷  Try a Trial PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
92213 Luxembourg ⤷  Try a Trial PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001-4-5-7-8-9-12-13-15 TRESIBA 20130123
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.