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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Queensland Health
McKinsey
US Department of Justice
Medtronic

Generated: March 18, 2019

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APIDRA SOLOSTAR Drug Profile

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Which patents cover Apidra Solostar, and when can generic versions of Apidra Solostar launch?

Apidra Solostar is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are twenty-three patents protecting this drug.

This drug has two hundred and ninety-three patent family members in forty-two countries.

The generic ingredient in APIDRA SOLOSTAR is insulin glulisine recombinant. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glulisine recombinant profile page.

Drug patent expirations by year for APIDRA SOLOSTAR
Pharmacology for APIDRA SOLOSTAR
Ingredient-typeInsulin
Drug ClassInsulin Analog
Synonyms for APIDRA SOLOSTAR
(3(sup B)-L-Lysine,29(sup B)-L-glutamic acid)insulin (human)
207748-29-6
7XIY785AZD
Apidra
B3-lysyl-B29-glutamylinsulin
HMR 1964
Insulin (human), 3B-L-lysine-29B-L-glutamic acid-
Insulin (human),3(sup B)-L-lysine,29(sup B)-L-glutamic acid-
Insulin glulisine [USAN:INN:JAN]
Insulin, Lys(B3)-Glu(B29)-
Insulin, lysyl(B3)-glutamyl(B29)-
UNII-7XIY785AZD

US Patents and Regulatory Information for APIDRA SOLOSTAR

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
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 ➤ 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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International Patents for APIDRA SOLOSTAR

Supplementary Protection Certificates for APIDRA SOLOSTAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 35/2013 Austria ➤ Try a Free Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC AND INSULIN ASPART UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, EU/1/12/806/008 (MITTEILUNG) 20180123
2107069 C300597 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
0368187 00C0023 France ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
2498802 300883 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
2107069 300596 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
0885961 91138 Luxembourg ➤ Try a Free Trial 91138, EXPIRES: 20190927
2107069 31/2013 Austria ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/807/001, EU/1/12/807/004, EU/1/12/807/005, EU/1/12/807/007, EU/1/12/807/008, EU/1/12/807/009, EU/1/12/807/012, EU/1/12/807/013, EU/1/12/807/015 (MITTEILUNG) 20130123
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Federal Trade Commission
Harvard Business School
QuintilesIMS
Colorcon
McKesson

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