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Generated: September 21, 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 fifty-four patent family members in twenty-seven 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 list137
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, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes► Subscribe► 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
8,888,750Pen-type injector► Subscribe
9,028,454Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,553,299Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,935,088Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,918,833Pen-type injector► Subscribe
9,205,197Drug delivery device dose setting mechanism► Subscribe
7,905,867Pen-type injector► Subscribe
9,623,190Pen-type injector► Subscribe
8,876,782Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,574,198Drive 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
Denmark1920794► Subscribe
European Patent Office2281592► Subscribe
European Patent Office1603611► Subscribe
SloveniaEP1601395► Subscribe
Denmark1603611► Subscribe
China100467078► Subscribe
Germany602004028221► Subscribe
Eurasian Patent Organization010390► Subscribe
Portugal2281592► Subscribe
Cyprus1109017► 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
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
13/34Ireland► SubscribePRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
/2005Austria► SubscribePRODUCT 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
00160Netherlands► SubscribePRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
00698Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/004 20130123
2004005,C0792290Lithuania► SubscribePRODUCT 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
2107069/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
QuintilesIMS
US Army
Johnson and Johnson
Citi
Cantor Fitzgerald
Julphar
US Department of Justice
McKinsey
Novartis

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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