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-one 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 FOUGERA PHARMS INC on December 16^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
Drug Prices:	Drug price information for YUTIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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	7,998,108		Y
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018		RX	Yes	Yes	8,871,241		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	9,192,579
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	6,217,895
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	9,849,085
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	8,574,659
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	8,252,307

International Patents for YUTIQ

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

Country	Patent Number	Title	Estimated Expiration
Canada	2406277	DISPOSITIFS D'ADMINISTRATION DE MEDICAMENT A LIBERATION PROLONGEE, PROCEDES D'UTILISATION ET PROCEDES DE FABRICATION CORRESPONDANTS (SUSTAINED RELEASE DRUG DELIVERY DEVICES, METHODS OF USE, ANDMETHODS OF MANUFACTURING THEREOF)
Denmark	1635787
Japan	2007524628
Japan	2006514658
Austria	460901

Supplementary Protection Certificates for YUTIQ

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: YUTIQ

Last updated: July 27, 2025

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Introduction

YUTIQ (fluocinolone acetonide intravitreal implant) is a sustained-release corticosteroid designed for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Approved by the U.S. Food and Drug Administration (FDA) in August 2018, YUTIQ addresses an unmet medical need in ophthalmology, offering long-term inflammation control with a single implant. As a specialized ophthalmic drug, its market trajectory hinges on several factors, including its therapeutic profile, competitive landscape, regulatory environment, and evolving ophthalmic disease prevalence. This report analyses the current market dynamics and project its financial trajectory over the coming years.

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Market Landscape and Key Drivers

1. Unmet Medical Need in Uveitis Treatment

Non-infectious uveitis remains a leading cause of visual impairment worldwide. Current treatments predominantly include corticosteroids and immunosuppressants. However, these often require frequent administration and are associated with significant adverse effects such as increased intraocular pressure (IOP), cataract formation, and systemic complications. YUTIQ’s single-implant approach provides a significant advantage, reducing treatment burden and improving compliance—factors that drive its adoption.

2. Therapeutic Advantages and Differentiation

YUTIQ delivers sustained corticosteroid release over up to three years, providing consistent inflammation control. Its targeted intravitreal delivery minimizes systemic exposure and side effects compared to systemic immunosuppressants. Clinical trials demonstrated a favorable safety profile, pivotal for ophthalmic therapeutics. Its differentiation aligns with a growing preference for long-acting, minimally invasive treatments in ophthalmology.

3. Competitive Landscape

Despite innovative features, YUTIQ faces competition from other corticosteroid implants, notably:

• Iluvien (flucocinolone acetonide implant): Approved for diabetic macular edema, also used off-label for uveitis.
• Ozurdex (dexamethasone implant): Offers short-term release (up to 6 months), but less appealing for long-term management.
• Other emerging therapies: Biologics and alternative corticosteroids are in clinical development targeting uveitis.

The competitive set causes market pressure but positions YUTIQ as the preferred long-term solution, especially after convincing ophthalmologists of its durability and safety profile.

4. Regulatory and Reimbursement Environment

YUTIQ’s FDA approval paved the way for reimbursement pathways, with payers increasingly recognizing the value of long-acting implants. Reimbursement coverage influences patient access and physician prescribing patterns. Additionally, approval in European markets and emerging markets remains crucial for global growth, with local regulatory hurdles and healthcare infrastructure being determinants.

5. Market Penetration and Adoption

Market penetration was initially modest post-launch but is expected to accelerate as ophthalmologists adopt the implant for suitable patients. Training, awareness campaigns, and evidence from subsequent real-world studies will enhance acceptance. YUTIQ’s positioning with a defined niche—patients requiring long-term intraocular inflammation management—may facilitate rapid growth within specialist ophthalmology practices.

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Financial Trajectory and Revenue Forecasts

1. Initial Revenue and Growth Trends

YUTIQ's launch in 2018 projected modest initial revenues, aligning with the slow uptake typical for specialized ophthalmic therapies. The drug’s sales grew gradually as clinical validation and physician familiarity increased. For fiscal year 2022, preliminary estimates suggest revenues in the range of $50-70 million, reflecting early momentum—consistent with similar ophthalmic drug launches.

2. Factors Influencing Revenue Growth

• Expansion into international markets: European approval in 2019 broadened access, with additional approvals in Asia and the Middle East being pursued.
• Adoption rates among retina specialists: Increased clinician familiarity and positive outcomes are expected to accelerate revenue.
• Healthcare infrastructure and reimbursement policies: Favorable coverage in key markets will support growth.
• Pricing strategies: Premium pricing justified by long-acting benefits and improved patient outcomes support revenue per unit.

3. Long-term Revenue Projections

Modeling a conservative compound annual growth rate (CAGR) of 15-20% over the next five years, revenues could reach $120-150 million by 2027. This projection assumes steady adoption, incremental expansion into new markets, and an absence of significant market disruptions.

4. Potential Market Expansion and Upside Risks

• New indications: Research exploring YUTIQ’s efficacy in other ocular inflammatory diseases could unlock additional revenue streams.
• Combination therapies: Integration with other ophthalmic treatments might enhance efficacy.
• Market disruptions: Emergence of superior or more cost-effective therapies could hamper growth.

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Market Risks and Challenges

• Safety concerns: Long-term corticosteroid use risks—such as elevated IOP and cataracts—necessitate vigilant monitoring, potentially impacting patient acceptance.
• Competitive innovations: Advancements in biologics or alternative delivery systems could challenge YUTIQ’s market position.
• Pricing pressures: Reimbursement negotiations may limit margins in some regions.
• Manufacturing and supply chain risks: Maintaining quality and capacity is critical for supply reliability.

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Emerging Opportunities and Strategic Outlook

YUTIQ’s market trajectory is poised for steady upward growth contingent on strategic positioning. Key opportunities include:

• Geographic expansion: Securing approvals across diverse markets enhances revenue potential.
• Clinical evidence generation: Long-term, real-world outcomes will reinforce YUTIQ’s value proposition.
• Physician education: Targeted campaigns increase adoption among retina specialists and ophthalmologists.
• Partnerships: Collaborations with healthcare providers and payers can accelerate market penetration.

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Key Takeaways

• Dominant niche: YUTIQ addresses a significant unmet need in long-term uveitis management with a compelling benefit profile.
• Growth trajectory: Projected to achieve a CAGR of approximately 15-20% over five years, with revenues potentially exceeding $150 million.
• Market potential: International expansion and emerging indications present significant upside.
• Challenges: Safety profile, competitive landscape, and reimbursement policies require active management.
• Strategic focus: Enhancing clinical evidence, fostering physician adoption, and expanding global access sustain long-term growth.

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Frequently Asked Questions (FAQs)

1. How does YUTIQ compare to other corticosteroid implants in the treatment of uveitis?
YUTIQ offers a longer duration of action (up to three years) compared to Ozurdex (up to six months), with a favorable safety profile. Its sustained-release mechanism reduces treatment frequency, improving adherence and convenience, making it a preferred option for long-term management.

2. What are the primary safety concerns associated with YUTIQ?
The main safety issues include increased intraocular pressure and cataract development, common risks associated with corticosteroids. Proper patient monitoring mitigates these risks, and the implant’s targeted delivery minimizes systemic side effects.

3. What factors influence the adoption of YUTIQ in global markets?
Regulatory approvals, reimbursement coverage, physician awareness, and clinical evidence significantly impact adoption. Cultural acceptance and healthcare infrastructure also influence market penetration, with developing regions requiring tailored strategies.

4. Can YUTIQ become a first-line treatment for uveitis?
While promising, current guidelines and clinical experience position YUTIQ as a long-term management option for suitable patients rather than an initial first-line therapy. Its role may expand as more evidence accumulates.

5. What is the competitive outlook for YUTIQ over the next decade?
YUTIQ's competitive advantage hinges on its long-term efficacy and safety. While emerging therapies, especially biologics, could challenge corticosteroids, YUTIQ’s key benefits—durability, targeted delivery—offer a sustainable niche if clinical outcomes continue to favor its profile.

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Conclusion

YUTIQ's market dynamics reflect a carefully balanced interplay of innovative drug delivery, unmet clinical needs, and evolving ophthalmology practices. Its financial trajectory is optimistic, driven by increasing adoption, expanding indications, and global market penetration. Navigating safety concerns, competitive pressures, and reimbursement landscapes will be pivotal to realizing its full market potential. Strategic investments in clinical research, physician education, and international expansion will determine its long-term success and profitability.

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References

[1] U.S. Food and Drug Administration. YUTIQ (fluocinolone acetonide intravitreal implant) approval announcement, 2018.
[2] MarketWatch. Ophthalmic drug market growth analysis, 2022.
[3] GlobalData. OPHTHALMIC DRUGS: Market Dynamics and Competitive Landscape, 2022.
[4] EvaluatePharma. 2023 forecasts for ophthalmic therapeutics.
[5] American Academy of Ophthalmology. Clinical guidelines for uveitis management, 2021.