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Last Updated: February 21, 2020

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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 twenty patents protecting this drug.

This drug has three hundred and thirteen patent family members in forty-six countries.

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

US ANDA Litigation and Generic Entry Outlook for Toujeo Solostar

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TOUJEO SOLOSTAR
Drug Prices for TOUJEO SOLOSTAR

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Recent Clinical Trials for TOUJEO SOLOSTAR

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SponsorPhase
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludPhase 4

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Recent Litigation for TOUJEO SOLOSTAR

Identify potential future generic entrants

District Court Litigation
Case NameDate
SANOFI-AVENTIS U.S. LLC v. MYLAN N v.2017-10-24
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.2016-09-16

See all TOUJEO SOLOSTAR litigation

PTAB Litigation
PetitionerDate
2019-05-02
Pfizer Inc.2019-05-02
2018-10-29

See all TOUJEO SOLOSTAR litigation

Pharmacology for TOUJEO SOLOSTAR
Ingredient-typeInsulin
Drug ClassInsulin Analog
Synonyms for TOUJEO SOLOSTAR
202757-02-6
21(sup A)-Glycine-30(sup B)a-L-arginine-30(sup B)b-L-arginine insulin (human)
21(sup A)-glycine-30(supp B)a-L-arginine-30(supp B)b-L-arginineinsulin (human)
224055-72-5
2ZM8CX04RZ
690638-50-7
Basaglar
HOE 71GT
HOE 901
Insulin (human), 21(sup A)-glycine-30(sup B)a-L-arginine-30(sup B)b-L-arginine-
Insulin glargine
Insulin glargine [USAN:INN:BAN]
Insulin, glycyl(A21)-arginyl(B31,B32)-
Lantus R
Lantus Solostar
Lusduna Nexvue
LY 2963016
MK-1293
Optisulin
Toujeo
UNII-2ZM8CX04RZ

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   Start Trial   Start Trial Y   Start Trial
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for TOUJEO SOLOSTAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 2013C/038 Belgium   Start Trial PRODUCT NAME: RYZODEG-INSULINE DEGLUDEC/INSULINE ASPARTE; AUTHORISATION NUMBER AND DATE: EU/1/12/806/001 20130121
2340033 300880 Netherlands   Start Trial PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
0368187 SPC/GB00/022 United Kingdom   Start Trial 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
2597103 CR 2017 00013 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
2107069 122013000061 Germany   Start Trial 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
0705275 32/2000 Austria   Start Trial PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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