YUTIQ Drug Patent Profile

Which patents cover Yutiq, and when can generic versions of Yutiq launch?

Yutiq 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 seventy-seven patent family members in twenty-seven countries.

The generic ingredient in YUTIQ 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 Yutiq

A generic version of YUTIQ was approved as fluocinolone acetonide by TARO on April 27^th, 1982.

Summary for YUTIQ

International Patents:	177
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	80
Patent Applications:	4,333
Drug Prices:	Drug price information for YUTIQ
What excipients (inactive ingredients) are in YUTIQ?	YUTIQ excipients list
DailyMed Link:	YUTIQ at DailyMed

See drug prices for YUTIQ

Pharmacology for YUTIQ

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for YUTIQ

YUTIQ is protected by two 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	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018		RX	Yes	Yes			Y
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018		RX	Yes	Yes			Y

Expired US Patents for YUTIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018

International Patents for YUTIQ

See the table below for patents covering YUTIQ 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 YUTIQ

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

YUTIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for YUTIQ

Introduction to YUTIQ

YUTIQ, a fluocinolone acetonide intravitreal implant, is a significant treatment option for autoimmune uveitis, a chronic and potentially blinding inflammatory eye disease. Developed by EyePoint Pharmaceuticals, YUTIQ has undergone substantial changes in its market and financial landscape, particularly following recent strategic shifts.

Mechanism of Action and Clinical Significance

YUTIQ works by releasing a consistent dose of fluocinolone acetonide over a period of 36 months, providing sustained intraocular corticosteroid therapy. This mechanism is crucial for managing the chronic inflammation associated with autoimmune uveitis, making it a valuable treatment option for patients[1][4].

Market Dynamics

Competitive Landscape

The market for autoimmune uveitis treatments is evolving rapidly, with YUTIQ facing competition from emerging therapies. The landscape is characterized by novel approaches to treatment, increased healthcare expenditure, and a growing need for efficient therapy options. Emerging products and late-stage therapies are expected to challenge YUTIQ's market dominance in the coming years[1][4].

Regulatory and Developmental Activities

YUTIQ has achieved significant regulatory milestones, including FDA approval. However, its market trajectory is influenced by ongoing research and development activities, as well as the launch of new therapies. The report provides a detailed analysis of YUTIQ's developmental activities, including clinical trial evaluations and future market assessments[1][4].

SWOT Analysis

A comprehensive SWOT analysis highlights YUTIQ's strengths, such as its established presence in the market and the consistent delivery of fluocinolone acetonide. However, it also identifies weaknesses, including the potential competition from new therapies and the need for continuous innovation. Opportunities include expanding into new markets and leveraging increasing healthcare spending, while threats include the emergence of more effective treatments and regulatory challenges[4].

Financial Trajectory

Revenue and Sales

EyePoint Pharmaceuticals' financial performance has been significantly impacted by the out-licensing of the YUTIQ franchise to Alimera in May 2023. For the first quarter of 2024, EyePoint's net product revenue from YUTIQ was $0.7 million, a substantial decrease from $7.4 million in the same period of 2023. This decline is due to the transition from a commercial to a pipeline-focused company[2][3].

Royalties and Collaborations

Despite the decrease in product sales, EyePoint saw a significant increase in net revenue from royalties and collaborations, totaling $11.0 million in the first quarter of 2024, compared to $0.3 million in the corresponding period of 2023. This increase is attributed to the partial recognition of deferred revenue from the license of the YUTIQ franchise, which will be recognized over a 2-year period[2].

Operating Expenses

EyePoint's operating expenses for the first quarter of 2024 increased to $45.0 million, primarily driven by growth in research and development costs, including activities related to the DURAVYU clinical trial, and personnel expenses. This increase was offset by reduced sales and marketing expenses following the exit from commercial operations[2].

Cash and Investments

As of March 31, 2024, EyePoint's cash and investments totaled $299.3 million, which is expected to fund the company's current and planned operations for at least the next twelve months. The company anticipates continuing to incur losses as it focuses on research and development and expects to meet its funding needs through a combination of revenue, licensing, and additional equity capital raises[2][3].

Strategic Shifts and Acquisitions

Licensing Agreement with Alimera

In May 2023, EyePoint granted an exclusive license for YUTIQ to Alimera for $75 million in cash and $7.5 million in quarterly installments throughout 2024. This deal marked a strategic pivot for EyePoint, transitioning from a commercial company to a biopharmaceutical pipeline-focused company. Alimera now owns the exclusive global rights to YUTIQ, except in certain regions where EyePoint has pre-existing licenses[2][5].

Impact on Market Presence

The licensing agreement is expected to enhance the commercial presence of YUTIQ, with Alimera planning to deploy a larger commercial team to increase the utilization of both YUTIQ and ILUVIEN. This move is anticipated to generate significant revenue and Adjusted EBITDA for Alimera in 2024[5].

Future Market Assessments

Forecasted Sales Data

The market forecast for YUTIQ from 2024 to 2032 indicates a changing market scenario due to extensive research and increased healthcare spending. The report provides in-depth analysis of forecasted sales data, which will be crucial for stakeholders in making decisions about their therapeutic portfolios[1][4].

Emerging Therapies

The launch of late-stage emerging therapies in the near future is expected to significantly impact the market. These new therapies could reshape market dynamics and pose a challenge to YUTIQ's dominance. However, YUTIQ's established presence and the ongoing development of new treatment strategies will continue to influence its market trajectory[1][4].

Key Takeaways

• Market Competition: YUTIQ faces increasing competition from emerging therapies in the autoimmune uveitis treatment market.
• Financial Performance: The out-licensing of YUTIQ to Alimera has significantly impacted EyePoint's revenue, with a shift towards royalties and collaborations.
• Strategic Shifts: EyePoint's transition to a pipeline-focused company and the licensing agreement with Alimera are key strategic moves.
• Future Outlook: The market forecast indicates continued relevance of YUTIQ, despite the emergence of new therapies.
• Regulatory and Developmental Activities: Ongoing research and regulatory milestones will continue to shape YUTIQ's market presence.

FAQs

1. What is YUTIQ and how does it work? YUTIQ is a fluocinolone acetonide intravitreal implant that releases a consistent dose of the corticosteroid over 36 months, providing sustained therapy for autoimmune uveitis.

2. Who currently holds the commercial rights for YUTIQ? Alimera holds the exclusive global rights for YUTIQ, except in certain regions where EyePoint has pre-existing licenses.

3. How has the licensing agreement with Alimera affected EyePoint's financials? The licensing agreement has led to a decrease in EyePoint's product sales revenue but an increase in royalties and collaborations revenue.

4. What are the future market prospects for YUTIQ? Despite emerging competition, YUTIQ is expected to remain a significant player in the autoimmune uveitis treatment market, with forecasted sales data indicating continued relevance.

5. What are the key factors influencing YUTIQ's market dynamics? Key factors include the emergence of new therapies, increased healthcare spending, and ongoing research and development activities.

Sources

1. ResearchAndMarkets.com - "US YUTIQ Market Size, Forecast, and Market Insight - 2032"
2. Biospace - "EyePoint Pharmaceuticals Reports First Quarter 2024 Financial Results and Highlights Recent Corporate Developments"
3. EyePoint Pharmaceuticals - Form 10-Q for the period ended March 31, 2024
4. GlobeNewswire - "US YUTIQ Autoimmune Uveitis Market Evaluation Now Available"
5. Optometry Times - "Alimera nabs US commercial rights for Yutiq"