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Generated: April 24, 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 fifteen patents protecting this drug.

This drug has three hundred and ten 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
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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-001 Jul 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471-002 Jul 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for ADLYXIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498802 300883 Netherlands ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
1196444 456 Finland ➤ Sign Up
1196444 122013000036 Germany ➤ Sign Up PRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
2498802 2017/022 Ireland ➤ Sign Up 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 CA 2013 00018 Denmark ➤ Sign Up
1196444 1390021-2 Sweden ➤ Sign Up 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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