ILUVIEN Drug Patent Profile

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 is one patent protecting this drug.

This drug has one hundred and seventy-six 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. Twenty-three 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 TARO on April 27^th, 1982.

Summary for ILUVIEN

International Patents:	176
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	8
Patent Applications:	4,343
Drug Prices:	Drug price information for ILUVIEN
What excipients (inactive ingredients) are in ILUVIEN?	ILUVIEN excipients list
DailyMed Link:	ILUVIEN at DailyMed

See drug prices for ILUVIEN

Recent Clinical Trials for ILUVIEN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Imperial College London	Phase 2/Phase 3
Johns Hopkins University	Phase 4
Alimera Sciences	Phase 4

See all ILUVIEN clinical trials

Pharmacology for ILUVIEN

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ILUVIEN

ILUVIEN is protected by one US patents.

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			Y

Expired US Patents for ILUVIEN

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
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014

International Patents for ILUVIEN

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0180825
Spain	2315282
Mexico	PA05007719	DISPOSITIVO DE LIBERACION SOSTENIDA Y METODO PARA LA ADMINISTRACION OCULAR DE AGENTES ADRENERGICOS. (SUSTAINED RELEASE DEVICE AND METHOD FOR OCULAR DELIVERY OF ADRENERGIC AGENTS.)

Supplementary Protection Certificates for ILUVIEN

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

ILUVIEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ILUVIEN

Introduction to ILUVIEN

ILUVIEN, developed by Alimera Sciences, is a sustained-release intravitreal implant designed to treat vision impairment associated with chronic diabetic macular edema (DME) that is insufficiently responsive to available therapies. The implant delivers sub-microgram levels of the corticosteroid fluocinolone acetonide over a period of up to 36 months.

Clinical Efficacy and Safety

The clinical efficacy and safety of ILUVIEN have been extensively evaluated in several studies. The FAME (Fluocinolone Acetonide for Macular Edema) Phase 3 clinical trials demonstrated sustained improvements in visual acuity and reductions in retinal edema over three years. These trials involved patients with DME who had previously been treated with laser photocoagulation and showed that ILUVIEN provided meaningful gains in best-corrected visual acuity (BCVA), with a mean increase of 3.6 letters at 36 months[3].

Market Expansion and Regulatory Approvals

ILUVIEN has seen significant market expansion across various regions. In Europe, it has been approved in several countries, including Germany, the UK, Portugal, France, Spain, and Austria, with ongoing national phase proceedings in Italy[4].

In the UK, the National Institute for Health and Care Excellence (NICE) has issued guidance recommending ILUVIEN for patients with chronic DME. Additionally, Alimera Sciences has partnered with Specialised Therapeutics Australia (STA) to distribute ILUVIEN in Australia and New Zealand, where regulatory approvals and reimbursement through the Pharmaceutical Benefits Scheme (PBS) are being pursued[4].

Financial Performance

Revenue Growth

Alimera Sciences has reported substantial revenue growth driven by the sales of ILUVIEN. In the first quarter of 2014, the company achieved revenue of $2.1 million, a significant increase from the fourth quarter of 2013, primarily due to increasing demand in Germany and the implementation of NICE guidance in the UK[1].

In more recent years, the financial trajectory has been even more impressive. For the fourth quarter of 2023, Alimera Sciences reported a consolidated net revenue of $26.3 million, an 88% increase compared to the fourth quarter of 2022. This growth was largely attributed to the acquisition of YUTIQ in May 2023 and the continued strong performance of ILUVIEN[2][5].

Full-Year Financial Highlights

For the full year 2023, Alimera Sciences reported a consolidated net revenue of $80.8 million, a 49% increase from 2022. U.S. net revenue increased by 66% to $56.7 million, while international net revenue grew by 21% to $24.0 million. These increases were driven by the acquisition of YUTIQ and the expanding market for ILUVIEN in international territories[2][5].

Adjusted EBITDA and Net Loss

Despite the significant revenue growth, Alimera Sciences reported a net loss of $20.1 million for 2023, slightly higher than the $18.1 million net loss in 2022. However, the company achieved positive adjusted EBITDA of $8.7 million in 2023, a marked improvement from the adjusted EBITDA loss of $(7.9) million in 2022[2][5].

Operating Expenses and Debt Agreements

The operating expenses for Alimera Sciences increased in 2023, primarily due to the costs associated with the addition of YUTIQ and the depreciation and amortization of assets acquired. Total operating expenses for 2023 were approximately $71.8 million, compared to $57.9 million in 2022[2].

The strong revenue growth has also triggered multiple revenue-based milestone payments embedded in Alimera Sciences' debt agreements with SLR. To support continued growth, SLR has agreed to increase the loan facility by $5 million, and the company has met a major milestone allowing for an additional year of interest-only payments on the loan facility[2][5].

International Market Growth

ILUVIEN's international market growth has been robust, with increasing demand in countries where the product is sold directly and through distributor partners. The partnership with STA in Australia and New Zealand is expected to further expand the product's reach and benefit thousands of diabetic patients suffering from vision impairment[4].

Expert Insights and Patient Benefits

According to Professor Mark Gillies from the University of Sydney, "ILUVIEN provides a new treatment option for those patients for whom other current therapies are unsuitable." This sentiment reflects the broader clinical community's recognition of ILUVIEN as a valuable treatment for patients with chronic DME who have limited other options[4].

Key Takeaways

• Clinical Efficacy: ILUVIEN has demonstrated sustained improvements in visual acuity and reductions in retinal edema in clinical trials.
• Market Expansion: Approved in several European countries and expanding into Australia and New Zealand.
• Revenue Growth: Significant increases in revenue driven by ILUVIEN and the acquisition of YUTIQ.
• Financial Performance: Positive adjusted EBITDA and increasing net revenue despite net losses.
• Operating Expenses: Increased due to the addition of YUTIQ and asset depreciation.
• International Growth: Strong demand in international markets, particularly through direct sales and distributor partnerships.

FAQs

Q: What is ILUVIEN used to treat?

ILUVIEN is used to treat vision impairment associated with chronic diabetic macular edema (DME) that is insufficiently responsive to available therapies.

Q: How long does the therapeutic effect of ILUVIEN last?

The therapeutic effect of ILUVIEN lasts for up to 36 months, delivering sustained sub-microgram levels of fluocinolone acetonide.

Q: In which countries is ILUVIEN approved?

ILUVIEN is approved in several European countries including Germany, the UK, Portugal, France, Spain, and Austria, with ongoing approvals in other regions.

Q: What were the key financial highlights for Alimera Sciences in 2023?

Alimera Sciences reported a consolidated net revenue of $80.8 million, an 88% increase in Q4 revenue, and positive adjusted EBITDA of $8.7 million for 2023.

Q: How has the acquisition of YUTIQ impacted Alimera Sciences' financial performance?

The acquisition of YUTIQ in May 2023 significantly contributed to the revenue growth of Alimera Sciences, particularly in the U.S. segment, and helped achieve positive adjusted EBITDA.

Sources

1. Alimera Sciences Reports Revenue Growth: Alimera Sciences, Inc., "Alimera reports Iluvien sales growth," American Academy of Ophthalmology, May 9, 2014.
2. Fourth Quarter and Full Year 2023 Results: Alimera Sciences, "Alimera Sciences Reports Fourth Quarter and Full Year 2023 Results," GlobeNewswire, March 7, 2024.
3. Clinical Studies & Data: Alimera Sciences, "Clinical Studies & Data - ILUVIEN," ILUVIEN.
4. STA to License ILUVIEN: Specialised Therapeutics Australia, "STA to License New Drug – ILUVIEN® – to Improve Vision in Patients with Diabetes-Induced Vision Loss," April 28, 2014.
5. Alimera Sciences Reports Fourth Quarter and Full Year 2023 Results: BioSpace, "Alimera Sciences Reports Fourth Quarter and Full Year 2023 Results," March 7, 2024.