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Last Updated: July 5, 2020

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LANTUS SOLOSTAR Drug Profile


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

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 twenty 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. Two 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 Lantus Solostar

Lantus Solostar was eligible for patent challenges on April 20, 2004.

Annual sales in 2017 were $185mm indicating the motivation for generic entry (peak sales were $663mm in 2008).

There have been seven 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 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

Pharmacology for LANTUS SOLOSTAR
Ingredient-typeInsulin
Drug ClassInsulin Analog

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   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 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 LANTUS SOLOSTAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0705275 C300021 Netherlands   Start Trial PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
2107069 C201300035 Spain   Start Trial PRODUCT NAME: INSULINA DEGLUDEC; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001, 004, 005, 007-009, 012, 013, 015; DATE OF AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001, 004, 005, 007-009, 012, 013, 015; DATE OF FIRST AUTHORISATION IN EEA: 20130121
2107069 300596 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
2107069 1390029-5 Sweden   Start Trial PRODUCT NAME: INSULIN DEGLUDEK
2107069 35/2013 Austria   Start Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC AND INSULIN ASPART UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, EU/1/12/806/008 (MITTEILUNG) 20180123
2107069 92213 Luxembourg   Start Trial PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001-4-5-7-8-9-12-13-15 TRESIBA 20130123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKesson
AstraZeneca
Mallinckrodt
Boehringer Ingelheim
Colorcon

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