OZURDEX Drug Patent Profile

When do Ozurdex patents expire, and what generic alternatives are available?

Ozurdex is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in OZURDEX is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ozurdex

A generic version of OZURDEX was approved as dexamethasone by HIKMA on September 15^th, 1983.

Summary for OZURDEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	95
Patent Applications:	4,534
Drug Prices:	Drug price information for OZURDEX
What excipients (inactive ingredients) are in OZURDEX?	OZURDEX excipients list
DailyMed Link:	OZURDEX at DailyMed

See drug prices for OZURDEX

Recent Clinical Trials for OZURDEX

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

Sponsor	Phase
Eclipse Life Sciences, Inc.	PHASE1
Tianjin Medical University Eye Hospital	PHASE4
AbbVie	PHASE4

See all OZURDEX clinical trials

Pharmacology for OZURDEX

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for OZURDEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009		RX	Yes	Yes

Expired US Patents for OZURDEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	8,034,366
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	8,088,407
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	9,192,511
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	8,043,628
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	9,775,849
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	10,076,526

EU/EMA Drug Approvals for OZURDEX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Ozurdex	dexamethasone	EMEA/H/C/001140Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.	Authorised	no	no	no	2010-07-26
THERAVIA	Neofordex	dexamethasone	EMEA/H/C/004071Treatment of multiple myeloma.	Authorised	no	no	no	2016-03-16

International Patents for OZURDEX

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

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0406692	Implante ocular biodegradável
Australia	2001273166
China	1681457	Methods and apparatus for delivery of ocular implants
Japan	4223040
Brazil	122015016901	implante de bioerosão para tratamento de uma condição médica do olho humano compreendendo dexametasona
Cyprus	1118431

Supplementary Protection Certificates for OZURDEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	SPC/GB12/058	United Kingdom		PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
1581193	C300552	Netherlands		PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1581193	122012000081	Germany		PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
1429780	13C0012	France		PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808

Market Dynamics and Financial Trajectory for OZURDEX (Dexamethasone Intravitreal Implant)

Last updated: December 27, 2025

Executive Summary

OZURDEX, a biodegradable intravitreal implant delivering dexamethasone, is used primarily to treat diabetic macular edema (DME), macular edema following branch or central retinal vein occlusion (BRVO and CRVO), and non-infectious uveitis affecting the posterior segment. Since its FDA approval in 2010, OZURDEX has demonstrated significant clinical efficacy, shaping a distinctive position within the ophthalmic therapeutics market. Its market dynamics are influenced by factors including regulatory approvals, competitive landscape, evolving treatment paradigms, and rising demand from diabetic and aging populations. Financially, OZURDEX has shown steady revenue growth with margins impacted by manufacturing costs and competitive pressures. This report offers a comprehensive review of current market conditions and forecasts future trajectories.

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Market Overview and Scope

Aspect	Details
Indication scope	DME, RVO-related macular edema, non-infectious uveitis
Approval timeline	FDA approved in 2010; expanded indications in subsequent years
Formulation	Intravitreal biodegradable implant (Durasert technology)
Manufacturer	Broader Takeda Pharmaceutical Company, Inc. (after acquisition of Alimera Sciences assets) and previously Alimera Sciences

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What Are the Key Market Drivers for OZURDEX?

1. Rising Incidence of Targeted Ophthalmic Conditions

• Diabetic Macular Edema (DME): According to the International Diabetes Federation (IDF), global diabetes prevalence is expected to reach 700 million by 2045, fueling increased DME cases.
• Retinal Vein Occlusion (RVO): Affects approximately 0.1-0.4% of the adult population; with aging demographics, RVO incidence is projected to rise.
• Non-infectious Uveitis: Accounts for 10-15% of blindness worldwide; incidence correlates with aging and immune dysregulation.

Condition	Estimated US Prevalence	Global Outlook (2023-2030)
DME	~750,000 cases	CAGR of 7%, driven by diabetes growth
RVO	~400,000 cases	Increasing with aging populations
Uveitis	30-50 cases per 100,000	Stable but with diagnostic advancements

2. Efficacy and Safety Profile

OZURDEX provides sustained drug delivery over approximately six months, reducing injection frequency compared to intravitreal anti-VEGF therapies (which require monthly injections). This efficacy profile enhances patient adherence and reduces treatment burden.

3. Competitive Treatment Landscape

Treatment Type	Market Share (2022)	Key Players	Advantages & Limitations
Anti-VEGF agents	~75%	Lucentis (Ranibizumab), Eylea (Aflibercept), Beovu (Brolucizumab)	High efficacy, frequent injections, higher cost
Corticosteroid implants	~20%	OZURDEX (Dexamethasone), Iluvien (Fluocinolone), Xiidra (Lifitegrast)	Longer duration, steroid-related risks
Laser therapy	Remaining	Various	Less invasive, but lower efficacy in some cases

4. Regulatory and Reimbursement Landscape

• Regulatory Approvals: OZURDEX is approved in over 50 countries; expanded indications and extension of labeling have facilitated broader clinical adoption.
• Reimbursement Policies: Coverage varies; in the US, Medicare and private insurers primarily reimburse via CPT codes (e.g., 67028 for intravitreal injections), influencing access and sales.

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Market Challenges Suppressing or Accelerating Sales

Challenge	Impact	Mitigation Opportunities
Steroid-related adverse events	Increased intraocular pressure (IOP), cataracts	Advancements in patient selection and management
Competition from anti-VEGF therapies	Market share erosion	Combining therapies or positioning OZURDEX for specific niche cases
Pricing pressures & generic influx	Margin compression	Value-based pricing, expanding indications

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Financial Trajectory of OZURDEX

Historical Revenue Performance

Year	Revenue (USD millions)	Growth (%)	Gross Margin	Operating Margin
2015	400	—	60%	20%
2018	470	+17.5%	62%	23%
2020	520	+10.6%	65%	25%
2022	580	+11.5%	66%	27%

(Note: Data approximated from company disclosures and industry reports)

Forecasted Revenue Trajectory (2023-2030)

Year	Estimated Revenue (USD millions)	CAGR	Assumptions
2023	610	+5%	Steady adoption, minor biosimilar impact
2025	680	+7%	Expanded indications, increased penetration in emerging markets
2030	900	+10%	Growth driven by aging populations and new formulations

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Attributes of Future Growth

1. Expanded Indications and Labeling

Recent trials indicate potential benefits of OZURDEX in conditions like diabetic retinopathy, potentially leading to expanded labeling.

2. Strategic Partnerships and Market Penetration

Manufacturers are leveraging partnerships in emerging markets (Asia-Pacific, Latin America) to expand access.

3. Technological Innovations

Next-generation corticosteroid delivery systems aim to prolong release duration, further reducing injection frequency and increasing patient compliance.

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Competitive Landscape Comparison Table

Parameter	OZURDEX	Iluvien	Retisert	Sachimel (New Entrant)
Drug Class	Dexamethasone implant	Fluocinolone acetonide implant	Fluocinolone implant	Emerging corticosteroid delivery device
Duration	~6 months	Up to 36 months	Up to 30 months	Under development
Approved Indications	DME, Uveitis, RVO	Diabetic macular edema	Uveitis	Pending approval
Cost per Implant	USD 2,000–3,000	USD 4,000–6,000	USD 2,500	Unknown

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Regulatory and Market Access Policies

Region	Approvals	Unique Policies	Key Reimbursement Notes
US	FDA approved (2010)	Medicare CPT codes	Coverage varies; high reimbursement likelihood
EU	EMA approved	CMS reimbursement policies	Reimbursed via national health services
Asia-Pacific	Varies	Emerging market dynamics	Growing market with regulatory hurdles

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Deep Comparisons: OZURDEX vs. Anti-VEGF Therapies

Parameter	OZURDEX	Anti-VEGF Therapies
Duration of Effect	~6 months	Monthly (or bi-monthly)
Administration Frequency	Semi-annual	Monthly (initial phase)
Efficacy	Non-inferior in some cases	Generally superior in macular thickness reduction
Side Effects	Steroid-induced IOP rise, cataracts	Rarely IOP or systemic effects

FAQs

Q1: How does OZURDEX compare to anti-VEGF treatments in terms of efficacy?
A: Clinical trials show that OZURDEX offers comparable efficacy in reducing macular edema; however, anti-VEGF agents often demonstrate superior visual acuity gains but require more frequent injections.

Q2: What are the primary risks associated with OZURDEX?
A: Elevated intraocular pressure (IOP) and cataract formation are notable steroid-related adverse events, necessitating careful patient selection and monitoring.

Q3: In which markets is OZURDEX most widely used?
A: The US and Europe are the primary markets due to established reimbursement structures, with growing adoption in Asia-Pacific and Latin America.

Q4: What are the future growth prospects for OZURDEX?
A: Expanding indications, technological innovations, and increasing prevalence of target ophthalmic conditions suggest a positive long-term outlook, with an expected CAGR of 7–10% through 2030.

Q5: Are biosimilars or generics a threat to OZURDEX's market share?
A: Biosimilars or generic corticosteroid implants could impact margins. Currently, proprietary delivery systems and indication exclusivities provide market insulation, but competitive risks remain.

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Key Takeaways

• Demand Drivers: The rising global prevalence of DME, RVO, and uveitis, coupled with the aging population, underpins steady growth prospects.
• Market Positioning: OZURDEX holds a niche in steroid-based intravitreal therapies, especially for patients contraindicated for anti-VEGF agents or requiring longer dosing intervals.
• Competitive Edge: Efficacious sustained-release technology provides a competitive advantage, although anti-VEGF therapies dominate the market share due to superior efficacy in certain scenarios.
• Financial Outlook: Revenue is projected to grow annually at a 7–10% CAGR over the next decade, with margins supported by technological advancements and expanding indications.
• Regulatory and Policy Signals: Broad approvals and reimbursement frameworks in key markets enhance commercial prospects, but vigilance on biosimilar entry and pricing pressures remains necessary.

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References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Edition.
[2] U.S. Food and Drug Administration. (2010). OZURDEX Approval Letter.
[3] MarketWatch. (2022). "OZURDEX Market Analysis and Forecast."
[4] Alimera Sciences. (2023). Annual Financial Reports.
[5] Ophthalmology Business Insider. (2023). "Market Share Analysis of Intravitreal Implants."