You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Baxter
Merck
McKinsey
Boehringer Ingelheim
Johnson and Johnson
Medtronic

Last Updated: February 16, 2020

DrugPatentWatch Database Preview

Insulin glulisine recombinant - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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
Boston UniversityN/A
Massachusetts General HospitalN/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
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30

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 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 021629-002 Dec 20, 2005 DISCN 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
>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 insulin glulisine recombinant INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021629-002 Dec 20, 2005   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 SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009   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
2107069 C 2013 022 Romania   Start Trial PRODUCT NAME: COMBINATIE DE INSULINA DEGLUDEC SI INSULINA ASPART IN TOATEFORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/806/001,EU/1/12/806/004,EU/1/12/806/005,EU/1/12/806/007,00; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, 00; DATE OF FIRST AUTHORISATION IN EEA: 20130121
2498802 2017030 Norway   Start Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REG. NO/DATE: EU/1/16/1157 20170125
0705275 SPC/GB00/027 United Kingdom   Start Trial PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Express Scripts
Boehringer Ingelheim
Johnson and Johnson
Colorcon

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 verifification 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.