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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Boehringer Ingelheim
Citi
Accenture
US Department of Justice
McKinsey
US Army
AstraZeneca

Generated: April 20, 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
International Patents:301
US Patents:22
Tradenames:4
Applicants:2
NDAs:2
Drug Master File Entries: 39
Suppliers / Packagers: 5
Clinical Trials: 4,108
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 Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 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 MAX SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-002 Mar 26, 2018 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
7,905,867 Pen-type injector ➤ Sign Up
7,935,088 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
8,021,345 Pen-type injector ➤ Sign Up
7,553,299 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
2004005,C0792290 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
2013000062 Germany ➤ Sign Up PRODUCT 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
C0020 France ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
C0035 France ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Fuji
Cantor Fitzgerald
Daiichi Sankyo
QuintilesIMS
Johnson and Johnson
AstraZeneca
Medtronic
Express Scripts

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.