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Generated: July 23, 2017

DrugPatentWatch Database Preview

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 five 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-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for NDA: 201923

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Ophthalmic Agents
Otic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201923

Suppliers and Packaging for NDA: 201923

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;INTRAVITREALStrength0.19MG
Approval Date:Sep 26, 2014TE:RLD:Yes
Patent:8,252,307Patent Expiration:Jun 27, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:8,871,241Patent Expiration:Aug 12, 2027Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Sep 26, 2017
Regulatory Exclusivity Use:NEW PRODUCT

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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Johnson and Johnson
Chinese Patent Office
US Army
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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