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ILUVIEN

NDA

FLUOCINOLONE ACETONIDE | N201923 | ALIMERA SCIENCES INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

Today

8871241

Aug. 12, 2027

9849027

Nov. 7, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Iluvien (2023)

Total Spending

$10.5M

Total Claims

1,095

Beneficiaries

926

ASP Price

—

HCPCS: J7313 — Injection, fluocinolone acetonide, intravitreal implant (iluvien), 0.01 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain4 active DMFs7 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVFLUOCINOLONE ACETONIDE (PROCESS I)

DMF 44861982

FARMABIOS SPAFLUOCINOLONE ACETONIDE

DMF 173952004

TEVA PHARMACEUTICAL INDUSTRIES LTDFLUOCINOLONE ACETONIDE - PROCESS II

DMF 238752010

HENAN LIHUA PHARMACEUTICAL CO LTDFLUOCINOLONE ACETONIDE

DMF 404062024

DR REDDYS LABORATORIES LTDInactiveFLUOCINOLONE ACETONIDE

DMF 4181961

DR REDDYS LABORATORIES LTDInactiveFLUOCINOLONE ACETONIDE ACETATE

DMF 8061964

ANTIBIOTICOS SPAInactiveFLUOCINOLONE ACETONIDE

DMF 27871976

NOBEL CHEMICALS AB DIV FINE CHEMICALS INCInactiveFLUOCINOLONE ACETONIDE

DMF 29441977

QUATRUMInactiveFLUOCINOLONE ACETONIDE

DMF 73861988

FARMABOISInactiveFLUOCINOLONE ACETONIDE

DMF 74581988

SICOR SPAInactiveFLUOCINOLONE ACETONIDE 1,2-DIHYDRO

DMF 155722001

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 14, 2025	SUPPL -6	View Letter (PDF)
Mar 14, 2017	SUPPL -2	View Letter (PDF)
Sep 29, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.19MG

RLD

2 patents0 exclusivities▴

IMPLANT;INTRAVITREAL | Approved: Sep 26, 2014

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8871241	Aug 12, 2027	—	—	Yes	—	—
9849027	Nov 7, 2028	—	—	Yes		—