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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Covington
Dow
Colorcon
Cipla
Harvard Business School
Express Scripts
Moodys
Merck

Generated: August 19, 2018

DrugPatentWatch Database Preview

Insulin glulisine recombinant - Generic Drug Details

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What are the generic drug sources for insulin glulisine recombinant and what is the scope of insulin glulisine recombinant freedom to operate?

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-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin glulisine recombinant has two hundred and ninety-one patent family members in forty-two countries.

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

Summary for insulin glulisine recombinant
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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;IV (INFUSION), SUBCUTANEOUS 021629-001 Apr 16, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021629-002 Dec 20, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for insulin glulisine recombinant

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,205,276 Zinc-free and low-zinc insulin preparations having improved stability ➤ Try a Free Trial
7,205,277 Zinc-free and low-zinc insulin preparations having improved stability ➤ Try a Free Trial
7,553,299 Drive mechanisms suitable for use in drug delivery devices ➤ Try a Free Trial
7,850,662 Drive mechanisms suitable for use in drug delivery devices ➤ Try a Free Trial
7,905,867 Pen-type injector ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for insulin glulisine recombinant

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2000 Austria ➤ Try a Free Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609
2017000039 Germany ➤ Try a Free 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
2013000061 Germany ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
/2017 Austria ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGIN UND LIXISENATID; REGISTRATION NO/DATE: EU/1/16/1157 (MITTEILUNG) 20170113
00019 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Julphar
Mallinckrodt
Johnson and Johnson
US Department of Justice
Dow
Chubb
Deloitte
Boehringer Ingelheim

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