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Last Updated: January 24, 2020

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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 forty-three patent family members in forty-three countries.

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

US ANDA Litigation and Generic Entry Outlook for Adlyxin

Adlyxin will be eligible for patent challenges on July 27, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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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
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 ADLYXIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498802 2017/022 Ireland   Start Trial PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111
1196444 C300584 Netherlands   Start Trial PRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
2498802 300883 Netherlands   Start Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
1196444 C01196444/01 Switzerland   Start Trial PRODUCT NAME: LIXISENATIDUM; REGISTRATION NO/DATE: SWISSMEDIC 65958 28.03.2017
1196444 92175 Luxembourg   Start Trial PRODUCT NAME: LIXISENATIDE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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