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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Merck
Boehringer Ingelheim
Covington
McKesson
QuintilesIMS
Johnson and Johnson
Farmers Insurance

Generated: June 23, 2018

DrugPatentWatch Database Preview

INSULIN GLARGINE RECOMBINANT - Generic Drug Details

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What are the generic drug sources for insulin glargine recombinant and what is the scope of insulin glargine recombinant patent protection?

Insulin glargine recombinant
is the generic ingredient in four branded drugs marketed by Sanofi Aventis Us and Sanofi Us Services, and is included in two NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin glargine recombinant has three hundred and one patent family members in fifty countries.

There are thirty-nine drug master file entries for insulin glargine recombinant. Five suppliers are listed for this compound.
Summary for INSULIN GLARGINE RECOMBINANT
Pharmacology for INSULIN GLARGINE RECOMBINANT
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for INSULIN GLARGINE RECOMBINANT

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Us Services TOUJEO MAX SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-002 Mar 26, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Expired US Patents for INSULIN GLARGINE RECOMBINANT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for INSULIN GLARGINE RECOMBINANT

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
7,553,299 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
7,850,662 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
7,905,867 Pen-type injector ➤ Sign Up
7,935,088 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for INSULIN GLARGINE RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0020 France ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
/2005 Austria ➤ Sign Up PRODUCT 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
00597 Netherlands ➤ Sign Up PRODUCT 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
0596 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Citi
Colorcon
Farmers Insurance
Chubb
Harvard Business School
US Army
Federal Trade Commission
Teva

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.