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Last Updated: August 8, 2022

Insulin glargine - Biologic Drug Details


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Recent Clinical Trials for insulin glargine

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Tonghua Dongbao Pharmaceutical Co.,LtdPhase 1
Lannett Company, Inc.Phase 1
ParexelPhase 1

See all insulin glargine clinical trials

Recent Litigation for insulin glargine

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.2018-05-31
SANOFI-AVENTIS U.S. LLC v. MERCK SHARP & DOHME CORP.2017-08-08
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13

See all insulin glargine litigation

Pharmacology for insulin glargine
Ingredient-typeInsulin
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 glargine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 See Plans and Pricing 2012-02-21 Company disclosures
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 See Plans and Pricing 2013-04-23 Company disclosures
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 See Plans and Pricing 2014-08-12 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

These patents were obtained by searching patent claims

Supplementary Protection Certificates for insulin glargine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
SZ 34/2000 Austria See Plans and Pricing PRODUCT NAME: LANTUS - INSULIN GLARGIN
0091020-8 0090020-9 Sweden See Plans and Pricing PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
00C0023 France See Plans and Pricing PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
34/2000 Austria See Plans and Pricing PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609
C300019 Netherlands See Plans and Pricing PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
McKesson
AstraZeneca
Medtronic
Merck

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.