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Last Updated: December 9, 2019

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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 nineteen patents protecting this drug.

This drug has two hundred and ninety-three 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.

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

See all TOUJEO SOLOSTAR clinical trials

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
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.2016-09-16
Sanofi-Aventis U.S. LLC v. Eli Lilly and Company2014-01-30

See all TOUJEO SOLOSTAR litigation

PTAB Litigation
PetitionerDate
Pfizer Inc.2019-05-02
Mylan Pharmaceuticals Inc.2018-10-29
Mylan Pharmaceuticals Inc2018-09-10

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/035 Belgium   Start Trial PRODUCT NAME: TRESIBA-INSULINE DEGLUDEC; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001 20130121
2498802 2017/022 Ireland   Start Trial PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111
0368187 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609
0792290 0491022-0 Sweden   Start Trial PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2498802 17C0004 France   Start Trial PRODUCT NAME: INSULINE GLARGINE ET LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
2209800 C02209800/01 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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