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Last Updated: October 17, 2019

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ADLYXIN Drug Profile

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Which patents cover Adlyxin, and what generic alternatives are available?

Adlyxin is a drug marketed by Sanofi-aventis Us and is included in one NDA. There are sixteen patents protecting this drug.

This drug has three hundred and thirty-six patent family members in forty-two countries.

The generic ingredient in ADLYXIN is lixisenatide. One supplier is listed for this compound. Additional details are available on the lixisenatide profile page.

Summary for ADLYXIN
Drug patent expirations by year for ADLYXIN
Drug Prices for ADLYXIN

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Generic Entry Opportunity Date for ADLYXIN
Generic Entry Date for ADLYXIN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ADLYXIN

US Patents and Regulatory Information for ADLYXIN

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 208471-002 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 208471-002 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 ADLYXIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 92175 Luxembourg   Start Trial PRODUCT NAME: LIXISENATIDE
1196444 29/2013 Austria   Start Trial PRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Colorcon
Johnson and Johnson
Harvard Business School
Merck

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