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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
McKesson
Deloitte
McKinsey
Julphar
Teva
Daiichi Sankyo
Merck
Boehringer Ingelheim
QuintilesIMS

Generated: January 19, 2018

DrugPatentWatch Database Preview

TOUJEO SOLOSTAR Drug Profile

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When do Toujeo Solostar patents expire, 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.

The generic ingredient in TOUJEO SOLOSTAR is insulin glargine recombinant. There are thirty-nine 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
International Patents:244
US Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 12
Drug Prices:see details
DailyMed Link:TOUJEO SOLOSTAR at DailyMed
Drug patent expirations by year for TOUJEO SOLOSTAR
Pharmacology for TOUJEO SOLOSTAR
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for TOUJEO SOLOSTAR

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;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 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 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
8,021,345 Pen-type injector ➤ Subscribe
9,028,454 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
7,553,299 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
8,663,175 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
9,827,379 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
9,623,190 Pen-type injector ➤ Subscribe
9,205,197 Drug delivery device dose setting mechanism ➤ Subscribe
9,526,843 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
7,850,662 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
8,070,727 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for TOUJEO SOLOSTAR

Supplementary Protection Certificates for TOUJEO SOLOSTAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
213 Luxembourg ➤ Subscribe PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
C0085 France ➤ Subscribe PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
13/034 Ireland ➤ Subscribe APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
2017 00013 Denmark ➤ Subscribe PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
00160 Netherlands ➤ Subscribe PRODUCT 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
90042 Netherlands ➤ Subscribe PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
60026 Netherlands ➤ Subscribe PRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
C/GB05/024 United Kingdom ➤ Subscribe PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
91022-0 Sweden ➤ Subscribe PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
/2004 Austria ➤ Subscribe PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Covington
Novartis
Cerilliant
Julphar
Medtronic
Accenture
Queensland Health
Cipla

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