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Last Updated: April 13, 2024

APIDRA Drug Profile

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Recent Clinical Trials for APIDRA

Identify potential brand extensions & biosimilar entrants

Medical University of WarsawPhase 4
Massachusetts General HospitalPhase 2/Phase 3
Boston UniversityPhase 2/Phase 3

See all APIDRA clinical trials

Recent Litigation for APIDRA

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate

See all APIDRA litigation

Pharmacology for APIDRA
Established Pharmacologic ClassInsulin Analog
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 APIDRA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for APIDRA 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 APIDRA insulin glulisine Injection 021629 ⤷  Try a Trial 2017-06-20 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

These patents were obtained by searching patent claims

Supplementary Protection Certificates for APIDRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
SZ 2/2005 Austria ⤷  Try a Trial PRODUCT NAME: INSULIN GLULISINE
05C0009 France ⤷  Try a Trial PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE: EU/1/04/285/001 20040929
2005C/006 Belgium ⤷  Try a Trial PRODUCT NAME: INSULIN GLULISINE; AUTHORISATION NUMBER AND DATE: EU/1/04/285/001 20040928
122004000049 Germany ⤷  Try a Trial PRODUCT NAME: INSULIN GLULISINE; REGISTRATION NO/DATE: EU/1/04/285/001-020 20040927
SPC/GB05/024 United Kingdom ⤷  Try a Trial PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTERED: UK EU/1/04/285/001 20040929; UK EU/1/04/285/002 20040929; UK EU/1/04/285/003 20040929; UK EU/1/04/285/004 20040929; UK EU/1/04/285/005 20040929; UK EU/1/04/285/006 20040929; UK EU/1/04/285/007 20040929; UK EU/1/04/285/008 20040929; UK EU/1/04/285/009 20040929; UK EU/1/04/285/010 20040929; UK EU/1/04/285/011 20040929; UK EU/1/04/285/012 20040929; UK EU/1/04/285/013 20040929; UK EU/1/04/285/014 20040929; UK EU/1/04/285/015 20040929; UK EU/1/04/285/016 20040929; UK EU/1/04/285/017 20040929; UK EU/1/04/285/018 20040929; UK EU/1/04/285/019 20040929; UK EU/1/04/285/020 20040929
CA 2005 00018 Denmark ⤷  Try a Trial PRODUCT NAME: INSULIN GLULISIN
>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.