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Generated: September 23, 2018

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ADLYXIN Drug Profile

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When do Adlyxin patents expire, 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.

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

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
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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
175 Luxembourg ➤ Sign Up PRODUCT NAME: LIXISENATIDE
90021-2 Sweden ➤ Sign Up PRODUCT NAME: LIXISENATID; REG. NO/DATE: EU/1/12/811/001 20130201
13/015 Ireland ➤ Sign Up PRODUCT NAME: LIXISENATIDE; NAT REGISTRATION NO/DATE: EU/1/12/811/001 20130201; FIRST REGISTRATION NO/DATE: EU/1/12/811/002 01/02/2013 IRELAND EU/1/12/811/003 01/02/2013 IRELAND EU/1/12/811/004 01/02/2013 IRELAND EU/1/12/811/005 20130201
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
AstraZeneca
Merck
Cerilliant
Baxter
Harvard Business School
McKesson
Teva
US Department of Justice

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