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Last Updated: February 22, 2020

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Lixisenatide - Generic Drug Details

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What are the generic drug sources for lixisenatide and what is the scope of 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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for lixisenatide
International Patents:342
US Patents:16
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 9
Clinical Trials: 54
Formulation / Manufacturing:see details
DailyMed Link:lixisenatide at DailyMed
Recent Clinical Trials for lixisenatide

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SponsorPhase
University Hospital TuebingenPhase 4
EUCLIDPhase 2
RĂ©seau NS-ParkPhase 2

See all lixisenatide clinical trials

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 208471-002 Jul 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-001 Jul 27, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-001 Jul 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-001 Jul 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for lixisenatide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1196444 13C0021 France   Start Trial PRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001 20130201
1196444 CA 2013 00018 Denmark   Start Trial
2498802 17C0004 France   Start Trial PRODUCT NAME: INSULINE GLARGINE ET LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
2498802 132017000077235 Italy   Start Trial PRODUCT NAME: COMPOSIZIONE FARMACEUTICA COMPRENDENTE INSULINA GLARGINA E LIXISENATIDE(SULIQUA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1157, 20170113
1196444 456 Finland   Start Trial
1196444 2013/015 Ireland   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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