You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
Mallinckrodt
AstraZeneca
Colorcon
McKinsey

Last Updated: February 22, 2020

DrugPatentWatch Database Preview

LANTUS SOLOSTAR Drug Profile


Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

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 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. 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 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 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

< Available with Subscription >

  Start Trial

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

See drug prices for LANTUS SOLOSTAR

Drug Sales Revenue Trends for LANTUS SOLOSTAR

See drug sales revenues for LANTUS SOLOSTAR

Recent Clinical Trials for LANTUS SOLOSTAR

Identify potential brand extensions & 505(b)(2) entrants

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
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 LANTUS SOLOSTAR litigation

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

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   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
0792290 0491022-0 Sweden   Start Trial PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2597103 CA 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
0214826 C990042 Netherlands   Start Trial PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
>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:

Harvard Business School
Dow
McKesson
Baxter
Johnson and Johnson
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.