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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Serving leading biopharmaceutical companies globally:

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Last Updated: December 14, 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-seven patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for lixisenatide
International Patents:337
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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Hospital TuebingenPhase 4
RĂ©seau NS-ParkPhase 2
Cure ParkinsonPhase 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 208471-001 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   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   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
2498802 2017030 Norway   Start Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REG. NO/DATE: EU/1/16/1157 20170125
1196444 2013C/033 Belgium   Start Trial PRODUCT NAME: LYXUMIA-LIXISENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/12/811/001 20130205
1196444 C300584 Netherlands   Start Trial PRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
1196444 13C0021 France   Start Trial PRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001 20130201
1196444 456 Finland   Start Trial
1196444 29/2013 Austria   Start Trial PRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
1196444 1390021-2 Sweden   Start Trial PRODUCT NAME: LIXISENATID; REG. NO/DATE: EU/1/12/811/001 20130201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Dow
Medtronic
Merck
Moodys

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.