Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 15, 2019

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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 thirty-six patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for lixisenatide
International Patents:336
US Patents:16
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
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   See Pricing   See Pricing Y   See Pricing
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-001 Jul 27, 2016 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-001 Jul 27, 2016 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-001 Jul 27, 2016 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes   See Pricing   See Pricing   See Pricing
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>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 C300584 Netherlands   See Pricing PRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
1196444 C01196444/01 Switzerland   See Pricing PRODUCT NAME: LIXISENATIDUM; REGISTRATION NO/DATE: SWISSMEDIC 65958 28.03.2017
1196444 122013000036 Germany   See Pricing PRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
2498802 17C0004 France   See Pricing PRODUCT NAME: INSULINE GLARGINE ET LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
1196444 2013C/033 Belgium   See Pricing PRODUCT NAME: LYXUMIA-LIXISENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/12/811/001 20130205
1196444 13C0021 France   See Pricing PRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001 20130201
2498802 300883 Netherlands   See Pricing PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.