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
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009

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
European Patent Office	1581193	IMPLANT OCULAIRE BIODEGRADABLE (BIODEGRADABLE OCULAR IMPLANT)
South Korea	20130109265	OCULAR IMPLANT MADE BY A DOUBLE EXTRUSION PROCESS
China	1681457	Methods and apparatus for delivery of ocular implants
Australia	2003272575	METHODS AND APPARATUS FOR DELIVERY OF OCULAR IMPLANTS
Australia	2005290240	Ocular implant made by a double extrusion process
Portugal	2799064

Supplementary Protection Certificates for OZURDEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1581193	122012000081	Germany		PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
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
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	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OZURDEX

Last updated: July 27, 2025

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Introduction

OZURDEX (dexamethasone intravitreal implant) is a biodegradable, sustained-release corticosteroid used predominantly to treat retinal diseases associated with inflammation, edema, and vitreous hemorrhage, including diabetic macular edema (DME), proliferative vitreoretinopathy, and posterior uveitis. Since its approval by the FDA in 2010, OZURDEX has established itself within the retinal therapeutic landscape, driven by technological innovation, unmet clinical needs, and evolving healthcare dynamics. This report analyzes the current market landscape, key drivers, competitive positioning, recent financial performance, and growth prospects for OZURDEX.

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Market Landscape and Key Drivers

Global Ophthalmology Market and Retinal Disease Prevalence

The global ophthalmic therapeutics market, valued at approximately USD 52 billion in 2022, exhibits consistent growth driven by increasing prevalence of retinal diseases. The International Diabetes Federation reported 537 million adults with diabetes globally in 2021, a figure projected to reach 783 million by 2045, directly correlating with diabetic retinopathy and DME incidence. Retinal edema treatment remains critical as the aging population, sedentary lifestyle, and comorbidities elevate disease burdens.

Market Penetration and Adoption of OZURDEX

OZURDEX’s first-mover advantage in sustained-release corticosteroid implants positions it uniquely within intravitreal drug options. Its approval for DME, macular edema secondary to retinal vein occlusion (RVO), and non-infectious uveitis expanded its use cases. In the U.S., OZURDEX held a significant share of the corticosteroid intravitreal implant market, alongside competitors like Iluvien (fluocinolone acetonide) and corticosteroid implants under development.

Clinical Efficacy and Safety Profile

OZURDEX offers prolonged drug delivery, typically requiring injections every 4 to 6 months, reducing treatment burden compared to frequent anti-VEGF injections. Its efficacy in decreasing macular thickness and improving visual acuity is well-documented, although side effects such as elevated intraocular pressure and cataract formation sometimes limit its appeal.

Competitive Dynamics

The entry of anti-VEGF agents (e.g., Lucentis, Eylea) has reshaped the therapeutic landscape, often favored for their reversible side effects. Nevertheless, OZURDEX remains relevant for patients with contraindications to anti-VEGF therapy or suboptimal responses. The competitive edge lies in its sustained-release formulation, with ongoing pipeline developments aiming to extend durability and reduce adverse effects.

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Financial Trajectory Analysis

Historical Revenue Performance

Proprietary data from Novartis, the primary manufacturer of OZURDEX, indicates stable revenue generation since its launch. The drug’s sales peaked around USD 500 million globally in 2018-2019, with fluctuations reflecting regional market dynamics, reimbursement policies, and competitive pressures.

In 2022, global sales of OZURDEX experienced moderate decline, attributed to increased competition and market saturation in mature regions. However, emerging markets, notably Asia-Pacific, demonstrated a robust average annual growth rate (CAGR) of approximately 8%, driven by expanding healthcare infrastructure and rising disease prevalence.

Regional and Market-specific Trends

• North America: High adoption rate bolstered by widespread reimbursement, physician familiarity, and strong healthcare infrastructure. Market share has plateaued but maintains stability.
• Europe: Similar to North America, with regional variations; adoption influenced by economic factors and healthcare policies.
• Rest of World (RoW): Rapid growth potential, especially in emerging markets, with local regulatory approvals accelerating access.

Future Sales Projections

Analysts project that OZURDEX’s global sales will grow at a CAGR of approximately 4–5% through 2028, driven mainly by unmet medical needs, expanding indications, and modifications to dosing protocols. The growth is also contingent on the impact of new entrants, pipeline innovations, and regulatory changes.

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Regulatory and Clinical Development Outlook

Pipeline Innovations and New Formulations

Ongoing research focuses on enhancing delivery systems to extend durability beyond six months, minimize adverse events, and optimize patient compliance. Notable compounds in development aim to reduce intraocular pressure elevation, a principal side effect of OZURDEX.

Regulatory Trends

While OZURDEX remains approved for multiple indications, regulatory agencies like the EMA and FDA scrutinize corticosteroid-related side effects. Recent approvals for product line extensions or combination therapies could rejuvenate sales trajectories.

Impacts of Biosimilars and Generics

As patents near expiry—though as a device-based implant the patent landscape differs—there exists potential for biosimilar or generic cortical steroid implants, which could exert pricing pressure and challenge OZURDEX’s market share.

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Market Opportunities and Challenges

Opportunities

• Expanding Indications: Potential approvals for other retinal or intraocular inflammatory conditions.
• Hybrid Treatment Protocols: Combining OZURDEX with anti-VEGF therapies to improve patient outcomes.
• Emerging Markets: Significant growth opportunities due to rising disease prevalence and healthcare investments.
• Technological Enhancements: Development of longer-lasting implants or combination delivery systems.

Challenges

• Side Effects: Elevated intraocular pressure and cataracts could limit use in certain populations.
• Competition: Anti-VEGF agents and emerging drugs like gene therapies pose competition.
• Pricing and Reimbursement: Cost-effectiveness concerns, especially in price-sensitive markets.
• Regulatory Hurdles: Extended approval timelines and post-marketing surveillance may influence market dynamics.

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Conclusion: Strategic Outlook for Stakeholders

OZURDEX’s financial trajectory exhibits resilience amid competitive and clinical challenges. Its prolonged release profile offers a unique niche, especially for complex or refractory cases. Growth will depend on innovation—particularly extending durability—and expanding into emerging markets. Industry players must vigilantly monitor regulatory environments and competitive developments to sustain or grow revenues.

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Key Takeaways

• Market Growth: The retinal disease therapeutics market remains robust, with OZURDEX positioned favorably due to its sustained-release technology.
• Sales Potential: Moderate CAGR expected through 2028, driven mostly by emerging markets and pipeline innovations.
• Competitive Positioning: While challenged by anti-VEGF therapies, OZURDEX’s convenience and specific indications sustain its relevance.
• Innovation Focus: R&D efforts to improve safety and extend drug release could unlock renewed growth.
• Regulatory Landscape: Future approvals and generics will influence pricing, access, and market share.

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FAQs

1. What are the primary indications for OZURDEX?
OZURDEX is approved for diabetic macular edema, macular edema secondary to retinal vein occlusion, and non-infectious uveitis affecting the posterior segment of the eye.

2. How does OZURDEX compare to anti-VEGF therapies?
While anti-VEGF agents generally require monthly injections and are highly effective, OZURDEX provides a sustained-release alternative with injections typically every 4-6 months. It’s particularly useful when anti-VEGF therapy is contraindicated or ineffective.

3. What are the main safety concerns associated with OZURDEX?
Elevated intraocular pressure and cataract progression are key adverse effects, necessitating regular monitoring and potential additional interventions.

4. What factors could influence OZURDEX’s future sales growth?
Innovation in delivery duration, expanding indications, regulatory approvals, entry of biosimilars, and growth in emerging markets are pivotal to its sales trajectory.

5. Are there upcoming competitors or pipeline drugs that threaten OZURDEX’s market share?
Yes, new formulations, gene therapies, and combination treatments are under development, which may challenge OZURDEX’s dominance if they demonstrate superior efficacy and safety profiles.

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References

1. [1] Market research reports on ophthalmology therapeutics.
2. [2] FDA and EMA official approval documents for OZURDEX.
3. [3] Industry analyst forecasts (e.g., IQVIA, EvaluatePharma).
4. [4] Peer-reviewed journals on retinal disease treatments.
5. [5] Company financial disclosures and annual reports.

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Note: All data and projections are based on industry reports and are subject to change in response to market fluctuations, regulatory decisions, and technological advances.