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Generated: August 20, 2018

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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-one 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

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 ➤ 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 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 SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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 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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Non-Orange Book US Patents for APIDRA SOLOSTAR

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
8,021,345 Pen-type injector ➤ Sign Up
8,876,782 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
7,850,662 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
7,905,867 Pen-type injector ➤ Sign Up
7,205,276 Zinc-free and low-zinc insulin preparations having improved stability ➤ Sign Up
9,028,454 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for APIDRA SOLOSTAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017 00013 Denmark ➤ Sign Up PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
90029-5 Sweden ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEK
2/2005 Austria ➤ Sign Up PRODUCT NAME: INSULIN GLULISINE
00021 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
C0009 France ➤ Sign Up PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
0170 Netherlands ➤ Sign Up 300170, 20180615, EXPIRES: 20190927
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
Merck
Healthtrust
Colorcon
Julphar
Teva
Fish and Richardson
Accenture

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