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Last Updated: February 28, 2020

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APIDRA Drug Profile


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When do Apidra patents expire, and when can generic versions of Apidra launch?

Apidra is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are twenty-two patents protecting this drug.

This drug has forty-nine patent family members in thirty-two countries.

The generic ingredient in APIDRA is insulin glulisine recombinant. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glulisine recombinant profile page.

US ANDA Litigation and Generic Entry Outlook for Apidra

Apidra was eligible for patent challenges on April 16, 2008.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for APIDRA
Drug Prices for APIDRA

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Recent Clinical Trials for APIDRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Medical University of WarsawPhase 4
Boston UniversityN/A
Massachusetts General HospitalN/A

See all APIDRA clinical trials

Recent Litigation for APIDRA

Identify potential future generic entrants

District Court Litigation
Case NameDate
SANOFI-AVENTIS U.S. LLC v. MERCK SHARP & DOHME CORP.2017-08-08

See all APIDRA litigation

Pharmacology for APIDRA
Ingredient-typeInsulin
Drug ClassInsulin Analog
Synonyms for APIDRA
(3(sup B)-L-Lysine,29(sup B)-L-glutamic acid)insulin (human)
207748-29-6
7XIY785AZD
Apidra solostar
B3-lysyl-B29-glutamylinsulin
HMR 1964
Insulin (human), 3B-L-lysine-29B-L-glutamic acid-
Insulin (human),3(sup B)-L-lysine,29(sup B)-L-glutamic acid-
Insulin glulisine [USAN:INN:JAN]
Insulin, Lys(B3)-Glu(B29)-
Insulin, lysyl(B3)-glutamyl(B29)-
UNII-7XIY785AZD

US Patents and Regulatory Information for APIDRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021629-001 Apr 16, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No   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

Expired US Patents for APIDRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021629-001 Apr 16, 2004   Start Trial   Start Trial
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021629-002 Dec 20, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for APIDRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0368187 C300019 Netherlands   Start Trial PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609
0792290 C300160 Netherlands   Start Trial PRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
2209800 SPC/GB14/079 United Kingdom   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF, AND LIRAGLUTIDE, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF; REGISTERED: CH 65041 20140912; UK EU/1/14/947 20140922
2498802 2017/022 Ireland   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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