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Generated: November 19, 2018

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Details for New Drug Application (NDA): 208471

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NDA 208471 describes ADLYXIN, which is a drug marketed by Sanofi-aventis Us and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the ADLYXIN profile page.

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 208471
Tradename:ADLYXIN
Applicant:Sanofi-aventis Us
Ingredient:lixisenatide
Patents:15
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208471
Generic Entry Date for 208471*:
Constraining patent/regulatory exclusivity:
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 NDA: 208471
Suppliers and Packaging for NDA: 208471
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471 NDA Sanofi-Aventis U.S. LLC 0024-5745 0024-5745-02 1 KIT in 1 CARTON (0024-5745-02) * 3 mL in 1 SYRINGE (0024-5741-01) * 3 mL in 1 SYRINGE (0024-5740-00)
ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471 NDA Sanofi-Aventis U.S. LLC 0024-5747 0024-5747-02 2 SYRINGE in 1 CARTON (0024-5747-02) > 3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength0.15MG/3ML (0.05MG/ML)
Approval Date:Jul 27, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 27, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Nov 11, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Dec 28, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:IMPROVEMENT IN GLYCEMIC CONTROL IN TYPE 2 DIABETES MELLITUS PATIENTS BY USE OF A PEN INJECTOR

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