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Serving leading biopharmaceutical companies globally:

Healthtrust
Baxter
AstraZeneca
Dow
Colorcon
Cerilliant
Boehringer Ingelheim
US Department of Justice
Farmers Insurance
Accenture

Generated: January 16, 2018

DrugPatentWatch Database Preview

TOUJEO SOLOSTAR Drug Profile

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When do Toujeo Solostar patents expire, and when can generic versions of Toujeo Solostar launch?

Toujeo Solostar is a drug marketed by Sanofi Us Services and is included in one NDA. There are eighteen patents protecting this drug.

This drug has two hundred and forty-four patent family members in forty-four countries and forty-two supplementary protection certificates in twelve countries.

The generic ingredient in TOUJEO SOLOSTAR is insulin glargine recombinant. There are thirty-eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.
Summary for TOUJEO SOLOSTAR
International Patents:244
US Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 12
Drug Prices:see details
DailyMed Link:TOUJEO SOLOSTAR at DailyMed
Drug patent expirations by year for TOUJEO SOLOSTAR
Pharmacology for TOUJEO SOLOSTAR
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for TOUJEO SOLOSTAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 TOUJEO 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 ➤ Subscribe
9,028,454 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
7,553,299 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
8,663,175 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
9,827,379 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
9,623,190 Pen-type injector ➤ Subscribe
9,205,197 Drug delivery device dose setting mechanism ➤ Subscribe
9,526,843 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
7,850,662 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
8,070,727 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for TOUJEO SOLOSTAR

Supplementary Protection Certificates for TOUJEO SOLOSTAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2/2005 Austria ➤ Subscribe PRODUCT NAME: INSULIN GLULISINE
/2005 Austria ➤ Subscribe PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
C0009 France ➤ Subscribe 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
2013000062 Germany ➤ Subscribe PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
00698 Netherlands ➤ Subscribe PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
00597 Netherlands ➤ Subscribe 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
C0044 Belgium ➤ Subscribe PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
2013000061 Germany ➤ Subscribe 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
90067-4 Sweden ➤ Subscribe PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2004005,C0792290 Lithuania ➤ Subscribe PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Harvard Business School
Teva
Queensland Health
Argus Health
Cipla
Colorcon
US Department of Justice
Chubb

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