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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Dow
Mallinckrodt
UBS
US Department of Justice
Express Scripts
Chubb
Covington
Fuji

Generated: April 24, 2018

DrugPatentWatch Database Preview

LANTUS Drug Profile

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

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

This drug has two hundred and thirty-two patent family members in forty-four countries.

The generic ingredient in LANTUS is insulin glargine recombinant. There are thirty-nine 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.
Summary for LANTUS
International Patents:232
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Clinical Trials: 208
Drug Prices:see details
DailyMed Link:LANTUS at DailyMed
Drug patent expirations by year for LANTUS
Pharmacology for LANTUS
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for LANTUS

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 insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for LANTUS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for LANTUS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,561,331 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
9,533,105 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
8,574,198 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
8,512,297 Pen-type injector ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for LANTUS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0020 France ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
00597 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
2004005 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR
2209800/01 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Colorcon
Farmers Insurance
AstraZeneca
Chubb
UBS
Boehringer Ingelheim
Citi
QuintilesIMS

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.