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Fuji
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Generated: June 29, 2017

DrugPatentWatch Database Preview

LANTUS SOLOSTAR Drug Profile

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What is the patent landscape for Lantus Solostar, 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 fifteen patents protecting this drug.

This drug has one hundred and thirty-nine patent family members in twenty-six countries.

The generic ingredient in LANTUS SOLOSTAR is insulin glargine recombinant. There are thirty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.

Summary for Tradename: LANTUS SOLOSTAR

Patents:15
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Clinical Trials: see list135
Drug Prices:see details
DailyMed Link:LANTUS SOLOSTAR at DailyMed

Pharmacology for Tradename: LANTUS SOLOSTAR

Ingredient-typeInsulin
Drug ClassInsulin Analog
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;INJECTION021081-002Apr 27, 2007RXYesYes8,556,864► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes9,610,409► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes9,623,189► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes9,533,105► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes9,526,844► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: 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
9,526,843Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,918,833Pen-type injector► Subscribe
8,888,750Pen-type injector► Subscribe
8,021,345Pen-type injector► Subscribe
7,553,299Drive mechanisms suitable for use in drug delivery devices► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: LANTUS SOLOSTAR

Country Document Number Estimated Expiration
Denmark2263723► Subscribe
MexicoPA05009185► Subscribe
Portugal1603610► Subscribe
Chile2004000425► Subscribe
Portugal1920794► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LANTUS SOLOSTAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
213Luxembourg► SubscribePRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
2013000061Germany► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Moodys
US Department of Justice
Harvard Business School
Queensland Health
McKesson
Johnson and Johnson
Medtronic
Colorcon
Federal Trade Commission
Express Scripts

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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