RETISERT Drug Patent Profile

When do Retisert patents expire, and when can generic versions of Retisert launch?

Retisert is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in RETISERT 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 Retisert

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

Summary for RETISERT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	9
Patent Applications:	4,804
Drug Prices:	Drug price information for RETISERT
What excipients (inactive ingredients) are in RETISERT?	RETISERT excipients list
DailyMed Link:	RETISERT at DailyMed

See drug prices for RETISERT

Recent Clinical Trials for RETISERT

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

Sponsor	Phase
St. Michael's Hospital, Toronto	Phase 2
Pradeepa Yoganathan	Phase 2
Unity Health Toronto	Phase 2

See all RETISERT clinical trials

Pharmacology for RETISERT

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for RETISERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005		RX	Yes	Yes

Expired US Patents for RETISERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005

International Patents for RETISERT

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20010112357
Mexico	PA01009544	METODO PARA TRATAR Y/O PREVENIR ENFERMEDADES RETINALES CON CORTICOSTEROIDES DE LIBERACION SOSTENIDA. (METHOD FOR TREATING AND/OR PREVENTING RETINAL DISEASES WITH SUSTAINED RELEASE CORTICOSTEROIDS.)
Brazil	0010869

Supplementary Protection Certificates for RETISERT

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

Market Dynamics and Financial Trajectory for RETISERT

Last updated: December 27, 2025

Executive Summary

RETISERT (fluocinolone acetonide intravitreal implant) is a corticosteroid therapy approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Given its unique delivery mechanism and targeted therapeutic profile, the drug operates within a niche ophthalmic market, influenced by evolving clinical guidelines, patent landscapes, and competitor innovations. This analysis explores the current market environment, growth drivers, revenue projections, competitive positioning, and potential barriers shaping RETISERT's financial trajectory.

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What Is RETISERT and How Does It Fit Into the Ophthalmic Market?

Product Profile:

• Active Ingredient: Fluocinolone acetonide (Corticosteroid)
• Formulation: Intravitreal implant (surgically or office-injected)
• Indication: Chronic non-infectious posterior uveitis

Approval and Regulatory Status:

• FDA Approval Date: 2005 (original U.S. approval)
• Additional Approvals: Gained in multiple markets (e.g., EU, Japan) with specific indications and usage guidelines

Key Features:

• Duration: Provides sustained drug release over approximately 36 months
• Advantages: Reduces the need for frequent injections, improves patient compliance, and targets inflammation effectively

Market Positioning:
RETISERT's niche positioning as a long-acting corticosteroid implant sets it apart from conventional corticosteroid injections, which often require repeat dosing.

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What Are the Market Drivers Influencing RETISERT's Growth?

Driver	Details	Impact
Increasing Uveitis Prevalence	Estimated at approximately 115,000 cases annually in the U.S. alone [1]	Expands the potential patient pool
Unmet Medical Need	Chronic uveitis requires sustained therapy; limited long-term options	Drives demand for long-acting corticosteroids like RETISERT
Advancements in Diagnostic Techniques	Improved detection leads to earlier diagnosis	Potentially increases treatment prevalence
Regulatory Approvals & Indications	Expanding indications or labels reinforce market penetration	Boosts confidence among clinicians and payers
Pricing & Reimbursement Strategies	Favorable policies enable broader access	Affects revenue growth potential

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What Are the Challenges and Limitations in the RETISERT Market?

Challenge	Details	Financial Implication
Surgical and Invasive Administration Risks	Requires implantation; potential complications	May limit patient acceptance, suppressing sales growth
Competition from Biologics and Alternative Therapies	Use of systemic steroids, immunomodulators, and biologics	Could restrict RETISERT's market share
Patent Expiry & Generic Competition	Limited patent protections; entry of biosimilars or generics	Can erode pricing and margins
Cost-Effectiveness Concerns	High upfront device cost vs. non-surgical treatments	Payor resistance impacting reimbursement

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How Has the Financial Trajectory Evolved Since Launch?

Historical Revenue and Market Penetration (2005–2022)

Year	Estimated Global Revenue (USD Millions)	Key Notes
2005	N/A	Launch year; initial sales in nerves
2010	~$25 million	Steady adoption in U.S. and EU markets
2015	~$50 million	Expanded indications; increased awareness
2020	~$65 million	Saturation in early adopters, facing competition
2022	~$70 million	Market stabilization, modest growth

Note: Official financial disclosures are limited; estimations rely on market reports and industry insights.

Factors Influencing Revenue Trends

• Market Saturation: Early adopters accounted for significant penetration; growth plateaued as markets matured.
• Pricing Strategies: Premium pricing model due to device's long-lasting benefits.
• Reimbursement Landscape: Favorable coding and reimbursement policies in developed markets bolstered revenue streams.
• Introduction of Competign Therapies: New entrants, such as corticosteroid implants with shorter durations or biologics, impacted sales.

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What Are the Future Revenue Projections for RETISERT?

Projection Scope: 2023–2030, considering current trends, regulatory developments, and competitive landscape.

Year	Projected Revenue (USD Millions)	Assumptions	Notes
2023	~$75 million	Gradual recovery post-pandemic disruptions	Slight growth expected
2025	~$85 million	Expanded indications, increased adoption	Entry into emerging markets
2027	~$95 million	Introduction of next-generation implants, policy changes	Competitive pressures balanced by innovation
2030	~$110 million	Market expansion, enhanced reimbursement	Possible patent extensions or exclusivity periods

Note: Projections are speculative and contingent upon market dynamics and technological advancements.

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How Do Multiple-Source Comparisons Shape RETISERT's Market Position?

Product	Active Ingredient & Features	Duration of Effect	Marketed Indications	Estimated Global Sales (2022)
RETISERT	Fluocinolone acetonide, intravitreal implant	Up to 36 months	Non-infectious posterior uveitis	~$70 million
Iluvien	Fluocinolone acetonide, intravitreal implant	Up to 36 months	Diabetic macular edema	~$135 million
Ozurdex	Dexamethasone implant	Up to 6 months	Macular edema, uveitis	~$150 million

Analysis:
RETISERT primarily targets uveitis; however, similar implants like Iluvien and Ozurdex dominate broader indications such as diabetic macular edema or retinal vein occlusion. Patent preservation, tolerability, and indication-specific data influence clinician choice.

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What Are the Regulatory and Policy Trends Affecting RETISERT's Financial Outlook?

Policy/Trend	Impact	Current Status/Notes
Reimbursement Policies	Enhance market access	Favorable in the U.S. (Medicare, private payers) due to long-duration benefits
Orphan Drug & Fast Track Statuses	Accelerate approvals, extend exclusivity	Some regions offer incentives for rare disease treatments
Post-Market Surveillance and Safety Data	Drive updates and labeling	Critical for maintaining market authorization
Emerging Biosimilar Frameworks	Threaten exclusivities	Increasing in EU and Asia, potentially affecting revenues

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What Is the Competitive Landscape, and How Does It Affect RETISERT's Financial Trajectory?

Major Competitors:

• Iluvien (Alimera Sciences): Same drug molecule, marketed for diabetic macular edema, providing competition for long-acting implants.
• Ozurdex (Allergan/Bayer): Shorter duration, broader indications, higher market penetration.
• Retisert (Bausch + Lomb): An earlier corticosteroid implant with similar indications but different delivery mechanics.
• Emerging Biologics: Agents like anti-IL-6 or anti-TNF therapies in uveitis.

Impact on Market Share and Revenue

Competitor	Strengths	Weaknesses	Effect on RETISERT
Iluvien	Same active molecule, broader indications	Market maturation, patent expiries	Slight erosion of niche sales
Ozurdex	Shorter administration interval, versatile	Less durable effect	Limits RETISERT's clinical niche
Biologics	Potential for targeted therapy	Cost, safety profile	Possible displacement in severe cases

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What Are the Key Regulatory and Commercial Risks?

Risk Factor	Description	Mitigation Strategies
Patent Expiry	Loss of exclusivity could lead to biosimilar entry	Patent extensions, innovation pipeline
Regulatory Changes	Stricter approval, post-market requirements	Continuous safety monitoring
Clinical Trial Failures	Impairment of indications or safety concerns	Rigorous clinical evaluations
Market Penetration Challenges	Limited clinician adoption	Investment in physician education
Pricing Pressures	Reimbursement ceilings	Cost-effectiveness analyses

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Summary of Financial and Market Outlook

Aspect	Summary Insights
Growth Potential	Moderate, driven by niche indication and long-lasting effect
Revenue Maxima	Likely to stabilize around $100 million annually in mature markets
Expansion Levers	Additional indications, emerging markets, technological innovations
Challenges	Competition, patent landscape, invasive administration

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Key Takeaways

• RETISERT remains a specialized therapy with limited but steady market potential, primarily for chronic uveitis.
• Market growth hinges on clinical acceptance, reimbursement policies, and differentiation from competitors.
• The revenue trajectory shows modest growth, with potential upticks from expansion efforts and line extensions.
• Competition from shorter-acting implants and biologics presents ongoing challenges, demanding innovation and strategic positioning.
• Regulatory and patent protections are vital for maintaining exclusivity and revenue streams.

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FAQs

Q1: What are the primary indications for RETISERT?
A1: Chronic non-infectious posterior uveitis, especially when long-term corticosteroid therapy is needed.

Q2: How does RETISERT's duration compare to other ophthalmic implants?
A2: It provides therapeutic effects for up to 36 months—longer than dexamethasone implants like Ozurdex, which last about 6 months.

Q3: What are the main competitive advantages of RETISERT?
A3: Its sustained steroid release, reduced injection frequency, and targeted delivery improve patient compliance.

Q4: Are there significant barriers to RETISERT’s market expansion?
A4: Yes, primarily invasive implantation procedures, competition from alternative therapies, and patent challenges.

Q5: How might regulatory changes impact RETISERT's financial prospects?
A5: Stricter safety and efficacy requirements could delay approval of new indications or extensions, affecting revenue growth.

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References

[1] - U.S. National Eye Institute, "Uveitis," 2020.
[2] - MarketResearch.com, "Ophthalmic Drug Market Analysis," 2022.
[3] - FDA, "Approved Ophthalmic Devices," 2005–2022.
[4] - IMS Health, "Global Ophthalmic Drug Sales," 2022.