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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 201923


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NDA 201923 describes ILUVIEN, which is a drug marketed by Alimera Sciences Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ILUVIEN profile page.

The generic ingredient in ILUVIEN is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 201923
Tradename:ILUVIEN
Applicant:Alimera Sciences Inc
Ingredient:fluocinolone acetonide
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 201923
Medical Subject Heading (MeSH) Categories for 201923
Suppliers and Packaging for NDA: 201923
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923 NDA Alimera Sciences, Inc. 68611-190 68611-190-02 1 TRAY in 1 CARTON (68611-190-02) > 1 APPLICATOR in 1 TRAY > 1 IMPLANT in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;INTRAVITREALStrength0.19MG
Approval Date:Sep 26, 2014TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 26, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF DIABETIC MACULAR EDEMA
Patent:  Start TrialPatent Expiration:Aug 12, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 201923

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014   Start Trial   Start Trial
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014   Start Trial   Start Trial
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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