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Last Updated: October 14, 2019

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LANTUS SOLOSTAR Drug Profile

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Which patents cover Lantus Solostar, and what generic alternatives are available?

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

This drug has two hundred and seven patent family members in twenty-eight countries.

The generic ingredient in LANTUS 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 LANTUS SOLOSTAR
Drug Prices for LANTUS SOLOSTAR

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Drug Sales Revenue Trends for LANTUS SOLOSTAR

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Recent Clinical Trials for LANTUS SOLOSTAR

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SponsorPhase
GeropharmPhase 3
SanofiPhase 3
SanofiPhase 4

See all LANTUS SOLOSTAR clinical trials

Recent Litigation for LANTUS 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 LANTUS SOLOSTAR litigation

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

See all LANTUS SOLOSTAR litigation

Pharmacology for LANTUS SOLOSTAR
Ingredient-typeInsulin
Drug ClassInsulin Analog
Synonyms for LANTUS 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
Lusduna Nexvue
LY 2963016
MK-1293
Optisulin
Toujeo
Toujeo Solostar
UNII-2ZM8CX04RZ

US Patents and Regulatory Information for LANTUS 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 LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>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 LANTUS SOLOSTAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0885961 05C0009 France   See Pricing 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
2209800 122014000114 Germany   See Pricing PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
0792290 0491022-0 Sweden   See Pricing PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
0705275 41/2005 Austria   See Pricing PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
2209800 1490067-4 Sweden   See Pricing PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
0705275 C300021 Netherlands   See Pricing PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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