Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Mallinckrodt
Boehringer Ingelheim
McKesson
Moodys

Last Updated: December 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.

US ANDA Litigation and Generic Entry Outlook for Lantus Solostar

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

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

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

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
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   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
0792290 SPC/GB04/036 United Kingdom   Start Trial PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
2107069 C 2013 019 Romania   Start Trial PRODUCT NAME: INSULINA DEGLUDECIN TOATE FORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001; DATE OF FIRST AUTHORISATION IN EEA: 20130121
0705275 41/2005 Austria   Start Trial 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
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

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

Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
Express Scripts
Mallinckrodt
McKinsey
Boehringer Ingelheim

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