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Serving leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
UBS
Novartis
Colorcon
Mallinckrodt
Medtronic
Dow
Queensland Health
US Army

Generated: January 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 three branded drugs marketed by Sanofi Aventis Us and Sanofi Us Services, and is included in two NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin glargine recombinant has two hundred and forty-four patent family members in forty-four 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
International Patents:244
US Patents:20
Tradenames:3
Applicants:2
NDAs:2
Drug Master File Entries: 39
Suppliers / Packagers: 5
Clinical Trials: 4,107
Drug Prices:see low prices
DailyMed Link:INSULIN GLARGINE RECOMBINANT at DailyMed
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 ➤ 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 Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 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 Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 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 Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 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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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 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000 ➤ Subscribe ➤ Subscribe
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
9,205,197 Drug delivery device dose setting mechanism ➤ Subscribe
8,888,750 Pen-type injector ➤ Subscribe
7,553,299 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
9,827,379 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
8,574,198 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
8,021,345 Pen-type injector ➤ Subscribe
8,876,782 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
9,526,843 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
8,070,727 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
7,850,662 Drive mechanisms suitable for use in drug delivery devices ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for INSULIN GLARGINE RECOMBINANT

Supplementary Protection Certificates for INSULIN GLARGINE RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
91022-0 Sweden ➤ Subscribe PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
213 Luxembourg ➤ Subscribe PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
90042 Netherlands ➤ Subscribe PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
00698 Netherlands ➤ Subscribe PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
13/34 Ireland ➤ Subscribe PRODUCT: 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
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
2/2005 Austria ➤ Subscribe PRODUCT NAME: INSULIN GLULISINE
226 Luxembourg ➤ Subscribe PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
00021 Netherlands ➤ Subscribe PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Chubb
Merck
AstraZeneca
Fish and Richardson
Federal Trade Commission
McKesson
Johnson and Johnson
Boehringer Ingelheim
Medtronic

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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