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Serving 500+ biopharmaceutical companies globally:

Covington
Mallinckrodt
Cerilliant
Argus Health
Novartis
Baxter
Colorcon
Farmers Insurance
Moodys
US Department of Justice

Generated: June 26, 2017

DrugPatentWatch Database Preview

TOUJEO SOLOSTAR Drug Profile

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What is the patent landscape for Toujeo Solostar, and when can generic versions of Toujeo Solostar launch?

Toujeo Solostar is a drug marketed by Sanofi Us Services and is included in one NDA. There are seventeen patents protecting this drug.

This drug has one hundred and ninety-five patent family members in forty-two countries.

The generic ingredient in TOUJEO 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: TOUJEO SOLOSTAR

Patents:17
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list11
Drug Prices:see details
DailyMed Link:TOUJEO SOLOSTAR at DailyMed

Pharmacology for Tradename: TOUJEO 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 Us Services
TOUJEO SOLOSTAR
insulin glargine recombinant
SOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes8,603,044► SubscribeY ► Subscribe
Sanofi Us Services
TOUJEO SOLOSTAR
insulin glargine recombinant
SOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► Subscribe
Sanofi Us Services
TOUJEO SOLOSTAR
insulin glargine recombinant
SOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes9,623,189► SubscribeY ► Subscribe
Sanofi Us Services
TOUJEO SOLOSTAR
insulin glargine recombinant
SOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes9,533,105► SubscribeY ► Subscribe
Sanofi Us Services
TOUJEO SOLOSTAR
insulin glargine recombinant
SOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes8,992,486► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: TOUJEO 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
9,623,190Pen-type injector► Subscribe
7,935,088Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,028,454Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,070,727Drive mechanisms suitable for use in drug delivery devices► 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: TOUJEO SOLOSTAR

Country Document Number Estimated Expiration
Japan2006519075► Subscribe
Israel170481► Subscribe
Denmark2266648► Subscribe
Portugal1920794► Subscribe
Taiwan200507897► 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: TOUJEO SOLOSTAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013000062Germany► SubscribePRODUCT 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
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
/2004Austria► SubscribePRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Dow
Teva
Covington
US Army
Fuji
Argus Health
Novartis
McKesson

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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