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-three 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:	115
Clinical Trials:	93
Patent Applications:	4,583
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
Oxular Limited	Phase 2
Hospital for Special Surgery, New York	Phase 4
Karyopharm Therapeutics Inc	Phase 2

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

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/001140 Ozurdex 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/004071 Treatment 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
Japan	2004514702
Poland	223153
Brazil	0115772
Russian Federation	2294722	СПОСОБ ВВЕДЕНИЯ ГЛАЗНЫХ ИМПЛАНТАТОВ И ПРЕДНАЗНАЧЕННОЕ ДЛЯ ЭТОГО УСТРОЙСТВО (METHOD AND DEVICE FOR INTRODUCING EYE IMPLANTS)

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	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK 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
1581193	122012000081	Germany		PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727

OZURDEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OZURDEX

Introduction

OZURDEX, a dexamethasone intravitreal implant, is a significant player in the ophthalmic pharmaceutical market, particularly for the treatment of diabetic macular edema (DME), macular edema following central or branch retinal vein occlusion (BRVO/CRVO), and non-infectious uveitis. Here, we delve into the market dynamics and financial trajectory of OZURDEX.

Clinical Efficacy and Indications

OZURDEX has demonstrated strong clinical efficacy in various ophthalmic conditions. It is indicated for the treatment of adult patients with visual impairment due to DME, especially those who are pseudophakic or phakic, and for macular edema following BRVO/CRVO and non-infectious uveitis of the posterior segment of the eye[1][4].

Market Performance

Revenue Growth

In the fourth quarter of 2019, OZURDEX net revenues saw a significant increase of 132.8% compared to the prior year quarter, reaching $66.7 million. This growth was largely due to the return to full stock levels after a recall in certain international markets in 2018[2].

Competitive Landscape

OZURDEX competes with anti-VEGF treatments such as bevacizumab and ranibizumab. However, it has been shown to be a cost-effective and cost-saving strategy compared to these alternatives. For instance, a cost minimization analysis by NICE indicated that OZURDEX could save the UK NHS between £4,463 and £14,994 per treated patient over a three-year period[3].

Financial Trajectory

Revenue Trends

The financial performance of OZURDEX has been robust, with significant revenue growth in recent years. The drug's inclusion in Allergan's (now part of AbbVie) portfolio has contributed to the company's overall financial health. The revenue increase in 2019 was a notable highlight, reflecting the drug's market acceptance and clinical utility[2].

Cost-Effectiveness

From a financial perspective, OZURDEX offers several advantages. It requires fewer treatment and follow-up sessions compared to anti-VEGF treatments, which reduces overall costs to healthcare systems. The cost utility analysis and probabilistic sensitivity analysis have consistently shown that OZURDEX is a cost-effective option, even when considering the higher drug acquisition cost[3].

Safety and Adverse Reactions

Clinical Safety Profile

While OZURDEX has a favorable efficacy profile, it also comes with potential adverse reactions. Common adverse reactions include increased intraocular pressure (IOP), cataract, conjunctival hemorrhage, and visual acuity reduction. However, these reactions are generally manageable with temporary use of IOP-lowering medications or, in some cases, surgical procedures[1].

Impact on Financials

The management of adverse reactions, particularly IOP elevation, can have financial implications. For example, some patients may require additional medications or procedures, which can add to the overall treatment cost. However, the overall cost savings from reduced treatment sessions and lower administration costs often offset these additional expenses[1][3].

Market Dynamics

Regulatory Approvals and Guidelines

OZURDEX has received regulatory approvals in various regions, including Europe and the United States. Regulatory bodies like NICE have provided guidelines that support its use based on cost-effectiveness and clinical efficacy. These approvals and guidelines play a crucial role in shaping the market dynamics and adoption rates of the drug[1][3].

Patient and Physician Acceptance

The drug's acceptance among patients and physicians is high due to its sustained clinical benefits and relatively simple administration process. In the MEAD study, OZURDEX demonstrated sustained clinically significant vision improvements over a three-year period, which has contributed to its positive reception in the medical community[4].

Future Outlook

Market Growth Potential

Given its strong clinical efficacy and cost-effectiveness, OZURDEX is poised for continued market growth. The increasing prevalence of diabetic macular edema and other retinal diseases ensures a steady demand for effective treatments. Additionally, the drug's potential in emerging markets and its inclusion in AbbVie's portfolio suggest a promising future[2][4].

Competitive Strategies

To maintain its market position, the manufacturer will need to continue highlighting the drug's unique benefits, such as its sustained release mechanism and reduced need for frequent injections. Marketing strategies focusing on cost savings and patient outcomes will be crucial in competing with other ophthalmic treatments[3].

Key Takeaways

• Revenue Growth: OZURDEX has shown significant revenue growth, particularly in 2019.
• Cost-Effectiveness: It is a cost-effective option compared to anti-VEGF treatments.
• Clinical Efficacy: Demonstrated sustained vision improvements in clinical trials.
• Safety Profile: Associated with manageable adverse reactions, primarily increased IOP and cataract formation.
• Market Dynamics: Strong regulatory support and high acceptance among patients and physicians.
• Future Outlook: Poised for continued growth due to its unique benefits and increasing demand for retinal disease treatments.

FAQs

Q: What are the primary indications for OZURDEX?

OZURDEX is indicated for the treatment of adult patients with visual impairment due to diabetic macular edema (DME), macular edema following central or branch retinal vein occlusion (BRVO/CRVO), and non-infectious uveitis of the posterior segment of the eye.

Q: How does OZURDEX compare financially to anti-VEGF treatments?

OZURDEX is a cost-effective option compared to anti-VEGF treatments like bevacizumab and ranibizumab, saving the NHS between £4,463 and £14,994 per treated patient over three years.

Q: What are the common adverse reactions associated with OZURDEX?

Common adverse reactions include increased intraocular pressure (IOP), cataract, conjunctival hemorrhage, and visual acuity reduction.

Q: How has the revenue of OZURDEX performed in recent years?

In the fourth quarter of 2019, OZURDEX net revenues increased by 132.8% compared to the prior year quarter, reaching $66.7 million.

Q: What is the future outlook for OZURDEX in the market?

Given its strong clinical efficacy and cost-effectiveness, OZURDEX is poised for continued market growth, driven by increasing demand for effective retinal disease treatments and its inclusion in AbbVie's portfolio.

Sources

1. European Medicines Agency - Ozurdex, INN-Dexamethasone - European Medicines Agency
2. PR Newswire - Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results
3. NICE - NICE STA of OZURDEX® (dexamethasone intravitreal implant)
4. AbbVie - OZURDEX® Clinical Efficacy in DME