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Generated: November 12, 2018

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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 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.

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

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021629-001 Apr 16, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021629-002 Dec 20, 2005 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 ➤ Sign Up ➤ Sign Up
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
C/GB05/024 United Kingdom ➤ Sign Up PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
2014000114 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
C004/2005 Ireland ➤ Sign Up SPC004/2005: 20060308, EXPIRES: 20190926
0880 Netherlands ➤ Sign Up PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Farmers Insurance
Daiichi Sankyo
Moodys
Julphar
Harvard Business School
Baxter
US Army
Argus Health

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.