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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Cerilliant
Baxter
Moodys
Colorcon
Argus Health
Covington
Boehringer Ingelheim
Merck

Generated: August 16, 2018

DrugPatentWatch Database Preview

TOUJEO SOLOSTAR Drug Profile

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When do Toujeo Solostar patents expire, and what generic alternatives are available?

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

This drug has two hundred and fifty-two patent family members in forty-four countries.

The generic ingredient in TOUJEO SOLOSTAR is insulin glargine recombinant. There are forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ 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 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
8,070,727 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
7,553,299 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
9,623,190 Pen-type injector ➤ Sign Up
8,574,198 Drive mechanisms suitable for use in drug delivery devices ➤ 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 TOUJEO SOLOSTAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800/01 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
91022-0 Sweden ➤ Sign Up PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
C/GB00/022 United Kingdom ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE (LANTUS) OPTIONALLY IN THE FORM OF ESTERS THEREOF OR PHYSIOLOGICALLY TOLERATED SALTS THEREOF.; REGISTERED: UK EU/1/00/134/001 20000609; UK EU/1/00/134/002 20000609; UK EU/1/00/134/003 20000609; UK EU/1/00/134/004 20000609; UK EU/1/00/134/005 20000609; UK EU/1/00/134/006 20000609; UK EU/1/00/134/007 20000609
90029-5 Sweden ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEK
/2000 Austria ➤ Sign Up PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Covington
Julphar
Citi
AstraZeneca
Argus Health
Chubb
Harvard Business School
Chinese Patent Office

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