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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Moodys
Johnson and Johnson
Covington
Deloitte
Queensland Health
Baxter
Julphar

Generated: January 23, 2019

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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 insulin glulisine recombinant INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021629-001 Apr 16, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y 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 insulin glulisine recombinant INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021629-001 Apr 16, 2004 RX Yes Yes ➤ 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;INTRAVENOUS, SUBCUTANEOUS 021629-001 Apr 16, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021629-002 Dec 20, 2005 ➤ 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for insulin glulisine recombinant

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
0880 Netherlands ➤ Try a Free Trial PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
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
2014000114 Germany ➤ Try a Free Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Accenture
US Army
McKinsey
McKesson
UBS
US Department of Justice
Federal Trade Commission
Merck

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