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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Express Scripts
McKesson
Teva
AstraZeneca
Cipla
Dow
UBS
Medtronic

Generated: May 28, 2018

DrugPatentWatch Database Preview

Lixisenatide - Generic Drug Details

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What are the generic drug sources for lixisenatide and what is the scope of lixisenatide freedom to operate?

Lixisenatide
is the generic ingredient in one branded drug marketed by Sanofi-aventis Us and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lixisenatide has two hundred and sixty patent family members in forty countries.

One supplier is listed for this compound.
Summary for lixisenatide
International Patents:260
US Patents:13
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 48
Formulation / Manufacturing:see details
DailyMed Link:lixisenatide at DailyMed
Pharmacology for lixisenatide

US Patents and Regulatory Information for lixisenatide

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 ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-001 Jul 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-001 Jul 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y 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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Non-Orange Book US Patents for lixisenatide

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
6,528,486 Peptide agonists of GLP-1 activity ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for lixisenatide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/015 Ireland ➤ Sign Up PRODUCT NAME: LIXISENATIDE; NAT REGISTRATION NO/DATE: EU/1/12/811/001 20130201; FIRST REGISTRATION NO/DATE: EU/1/12/811/002 01/02/2013 IRELAND EU/1/12/811/003 01/02/2013 IRELAND EU/1/12/811/004 01/02/2013 IRELAND EU/1/12/811/005 20130201
2013000036 Germany ➤ Sign Up PRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
6 Finland ➤ Sign Up
175 Luxembourg ➤ Sign Up PRODUCT NAME: LIXISENATIDE
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Mallinckrodt
US Department of Justice
Citi
Deloitte
Julphar
Moodys
AstraZeneca
UBS

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.