ILUVIEN Drug Patent Profile

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When do Iluvien patents expire, and what generic alternatives are available?

Iluvien is a drug marketed by Alimera Sciences Inc and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and eighty-four patent family members in twenty-seven countries.

The generic ingredient in ILUVIEN is fluocinolone acetonide. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iluvien

A generic version of ILUVIEN was approved as fluocinolone acetonide by FOUGERA PHARMS INC on December 16^th, 1982.

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Summary for ILUVIEN

International Patents:	184
US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ILUVIEN

US Patents and Regulatory Information for ILUVIEN

ILUVIEN is protected by three US patents.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014		RX	Yes	Yes	9,849,027	⤷ Start Trial	Y			⤷ Start Trial
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014		RX	Yes	Yes	8,871,241	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ILUVIEN

See the table below for patents covering ILUVIEN around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2005200243		⤷ Start Trial
Australia	4174800		⤷ Start Trial
Australia	777727		⤷ Start Trial
Brazil	0010869		⤷ Start Trial
Canada	2367092	METHODE DE TRAITEMENT ET/OU DE PREVENTION DE MALADIES DE LA RETINE A L'AIDE DE CORTICOSTEROIDES A LIBERATION CONTROLEE (METHOD FOR TREATING AND/OR PREVENTING RETINAL DISEASES WITH SUSTAINED RELEASE CORTICOSTEROIDS)	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ILUVIEN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2233112	132014902285293	Italy	⤷ Start Trial	PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504
2233112	122014000063	Germany	⤷ Start Trial	PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

ILUVIEN (fluocinolone acetonide intravitreal implant): investment scenario and fundamentals analysis (2026)

Last updated: July 26, 2026

ILUVIEN is a late-stage, regulator-approved intravitreal corticosteroid implant for diabetic macular edema (DME) and is evaluated through FDA labeling, Orange Book/IP posture, and the economics of chronic retina care. The investment case is driven by (1) the duration of effect and retreatment patterns, (2) payer and practice adoption versus anti-VEGF and Ozurdex, (3) patent/exclusivity runway and generic/biosimilar-like replacement risk (implant platform and formulation), and (4) manufacturing and litigation intensity typical of specialty ophthalmology devices.

What is ILUVIEN and what drug is it for (indication, mechanism, dosing, administration)?

ILUVIEN is an intravitreal implant containing fluocinolone acetonide designed for sustained corticosteroid delivery to reduce inflammation and macular edema. It is used in ophthalmology, primarily for diabetic macular edema.

How is ILUVIEN dosed?

Single administration via intravitreal implantation.
Retreatment is label- and clinician-dependent based on response and safety monitoring (including intraocular pressure and cataract risk, consistent with corticosteroids in ophthalmic use).

Mechanism relevant to payers and clinicians

Local corticosteroid exposure reduces inflammatory mediators implicated in DME pathophysiology.
Expected differentiators versus anti-VEGF are durability and reduced visit burden, counterbalanced by steroid class risks (IOP elevation, cataract progression).

Practical adoption drivers

Patient selection: chronicity, anti-VEGF response durability, contraindications, adherence barriers.
Clinic workflow: procedure scheduling, post-injection monitoring cadence, and safety monitoring.

What is the Orange Book status of ILUVIEN and what patents protect fluocinolone acetonide implants?

No response.

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