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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Johnson and Johnson
Medtronic
AstraZeneca
Harvard Business School
US Army
Colorcon
McKesson
McKinsey
Healthtrust

Generated: January 16, 2018

DrugPatentWatch Database Preview

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 sixteen patents protecting this drug.

This drug has one hundred and eighty-three patent family members in twenty-seven countries and forty-two supplementary protection certificates in twelve countries.

The generic ingredient in LANTUS SOLOSTAR is insulin glargine recombinant. There are thirty-eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.
Summary for LANTUS SOLOSTAR
International Patents:183
US Patents:16
Applicants:1
NDAs:1
Suppliers / Packagers: 5
Clinical Trials: 142
Drug Prices:see details
DailyMed Link:LANTUS SOLOSTAR at DailyMed
Drug patent expirations by year for LANTUS SOLOSTAR
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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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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Non-Orange Book US Patents for LANTUS SOLOSTAR

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
7,935,088 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
8,888,750 Pen-type injector ➤ Subscribe
7,553,299 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
8,574,198 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
9,623,190 Pen-type injector ➤ Subscribe
9,526,843 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
9,028,454 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
9,205,197 Drug delivery device dose setting mechanism ➤ Subscribe
7,850,662 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
8,021,345 Pen-type injector ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for LANTUS SOLOSTAR

Supplementary Protection Certificates for LANTUS SOLOSTAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2/2005 Austria ➤ Subscribe PRODUCT NAME: INSULIN GLULISINE
/2005 Austria ➤ Subscribe PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
C0009 France ➤ Subscribe 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
2013000062 Germany ➤ Subscribe PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
00698 Netherlands ➤ Subscribe PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
00597 Netherlands ➤ Subscribe 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
C0044 Belgium ➤ Subscribe PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
2013000061 Germany ➤ Subscribe PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
90067-4 Sweden ➤ Subscribe PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2004005,C0792290 Lithuania ➤ Subscribe PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Accenture
QuintilesIMS
Fuji
AstraZeneca
Cerilliant
Chubb
Queensland Health
Healthtrust
Covington

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.

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