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Last Updated: December 12, 2019

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Insulin glulisine recombinant - Generic Drug Details

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What are the generic sources for insulin glulisine recombinant and what is the scope of patent protection?

Insulin glulisine recombinant is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us and is included in one NDA. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin glulisine recombinant has two hundred and sixty-nine patent family members in thirty-five countries.

There are forty drug master file entries for insulin glulisine recombinant. One supplier is listed for this compound.

Summary for insulin glulisine recombinant
Recent Clinical Trials for insulin glulisine recombinant

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

SponsorPhase
Institut de Recherches Cliniques de MontrealPhase 2
Massachusetts General HospitalN/A
Boston UniversityN/A

See all insulin glulisine recombinant clinical trials

Recent Litigation for insulin glulisine recombinant

Identify potential future generic entrants

District Court Litigation
Case NameDate
SANOFI-AVENTIS U.S. LLC v. MYLAN N v.2017-10-24
SANOFI-AVENTIS U.S. LLC v. MERCK SHARP & DOHME CORP.2017-08-08
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.2016-09-16

See all insulin glulisine recombinant litigation

PTAB Litigation
PetitionerDate
Pfizer Inc.2019-05-02
Mylan Pharmaceuticals Inc.2018-10-29
Mylan Pharmaceuticals Inc2018-09-10

See all insulin glulisine recombinant litigation

Pharmacology for insulin glulisine recombinant
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for insulin glulisine recombinant

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 insulin glulisine recombinant INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021629-002 Dec 20, 2005 DISCN 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
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
>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 insulin glulisine recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009   Start Trial   Start Trial
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 insulin glulisine recombinant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498802 122017000039 Germany   Start Trial PRODUCT NAME: SULIQUA (FIRMENEIGENER NAME DES MEDIZINISCHEN PRODUKTS) BZW. WIRKSTOFFZUSAMMENSETZUNG UMFASSEND INSULIN GLARGIN / LIXISENATID UND IHRE PHARMAZEUTISCH ANNEHMBAREN SALZE (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/16/1157 20170111
0885961 SPC/GB05/024 United Kingdom   Start Trial PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
2107069 13C0035 France   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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