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Last Updated: February 23, 2024

Insulin glargine - Biologic Drug Details


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Recent Clinical Trials for insulin glargine

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Aarhus University Hospital, Department of NephrologyPhase 4
Rigshospitalet, DenmarkPhase 4
Odense University Hospital, Department of NephrologyPhase 4

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
APTALIS PHARMA US, INC. v. DELCOR ASSET CORPORATION2015-12-22

See all insulin glargine litigation

Pharmacology for insulin glargine
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 ⤷  Try a Trial 2012-02-21 Company disclosures
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 ⤷  Try a Trial 2013-04-23 Company disclosures
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
2017/022 Ireland ⤷  Try a Trial PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111
0091020-8 0090020-9 Sweden ⤷  Try a Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
300883 Netherlands ⤷  Try a Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
10075022 Germany ⤷  Try a Trial PRODUCT NAME: INSULIN GLARGIN (LANTUS ); REGISTRATION NO/DATE: EU/1/00/134/001-007 20000609
2017030 Norway ⤷  Try a Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REG. NO/DATE: EU/1/16/1157 20170125
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
McKesson
AstraZeneca
Medtronic
Merck

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