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Serving leading biopharmaceutical companies globally:

Medtronic
Queensland Health
McKinsey
Argus Health
AstraZeneca
Cerilliant
Baxter
Citi
Chinese Patent Office
Fish and Richardson

Generated: December 18, 2017

DrugPatentWatch Database Preview

TOUJEO SOLOSTAR Drug Profile

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Which patents cover 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 eighteen patents protecting this drug.

This drug has two hundred and forty-four patent family members in forty-four countries and forty-two supplementary protection certificates in twelve countries.

The generic ingredient in TOUJEO 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 TOUJEO SOLOSTAR

Drug patent expirations by year for TOUJEO SOLOSTAR

Pharmacology for TOUJEO SOLOSTAR

Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Us ServicesTOUJEO SOLOSTARinsulin glargine recombinantSOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi Us ServicesTOUJEO SOLOSTARinsulin glargine recombinantSOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi Us ServicesTOUJEO SOLOSTARinsulin glargine recombinantSOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi Us ServicesTOUJEO SOLOSTARinsulin glargine recombinantSOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi Us ServicesTOUJEO SOLOSTARinsulin glargine recombinantSOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi Us ServicesTOUJEO SOLOSTARinsulin glargine recombinantSOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi Us ServicesTOUJEO SOLOSTARinsulin glargine recombinantSOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Sanofi Us ServicesTOUJEO SOLOSTARinsulin glargine recombinantSOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Sanofi Us ServicesTOUJEO SOLOSTARinsulin glargine recombinantSOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi Us ServicesTOUJEO SOLOSTARinsulin glargine recombinantSOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes► Subscribe► 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
9,827,379Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,888,750Pen-type injector► Subscribe
9,623,190Pen-type injector► Subscribe
8,021,345Pen-type injector► Subscribe
8,876,782Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,553,299Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,574,198Drive 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
7,935,088Drive 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
Denmark2011531► Subscribe
China102292120► Subscribe
Taiwan201607552► Subscribe
European Patent Office2263724► Subscribe
Canada2748958► Subscribe
European Patent Office2281592► Subscribe
Slovenia1944050► Subscribe
HungaryE032046► Subscribe
Hong Kong1092083► Subscribe
Germany202004021470► 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
0880Netherlands► SubscribePRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
00597Netherlands► SubscribePRODUCT 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
C0020France► SubscribePRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2017 00013Denmark► SubscribePRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
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Serving leading biopharmaceutical companies globally:

McKinsey
Farmers Insurance
Merck
QuintilesIMS
US Army
Queensland Health
Dow
Moodys
Cipla
Boehringer Ingelheim

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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