MAXIDEX Drug Patent Profile

Which patents cover Maxidex, and when can generic versions of Maxidex launch?

Maxidex is a drug marketed by Alcon and Harrow Eye and is included in two NDAs.

The generic ingredient in MAXIDEX 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 Maxidex

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

Summary for MAXIDEX

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	34
Patent Applications:	4,560
Drug Prices:	Drug price information for MAXIDEX
What excipients (inactive ingredients) are in MAXIDEX?	MAXIDEX excipients list
DailyMed Link:	MAXIDEX at DailyMed

See drug prices for MAXIDEX

Recent Clinical Trials for MAXIDEX

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

Sponsor	Phase
Medical College of Wisconsin	Phase 2
Benha University	Phase 1
Dana-Farber Cancer Institute	Phase 1

See all MAXIDEX clinical trials

Pharmacology for MAXIDEX

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for MAXIDEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon	MAXIDEX	dexamethasone sodium phosphate	OINTMENT;OPHTHALMIC	083342-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Harrow Eye	MAXIDEX	dexamethasone	SUSPENSION/DROPS;OPHTHALMIC	013422-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

EU/EMA Drug Approvals for MAXIDEX

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

MAXIDEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MAXIDEX

Market Overview of Ophthalmic Drugs

The U.S. ophthalmic drugs market is experiencing significant growth, driven by an increase in the prevalence of eye disorders and the introduction of new therapeutic agents. As of 2023, the market size was estimated at USD 15.53 billion and is anticipated to grow at a CAGR of 7.4% from 2024 to 2030[4].

Position of MAXIDEX in the Market

MAXIDEX, a dexamethasone ophthalmic suspension and ointment, is a key player in this market. It is indicated for steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe[3].

Revenue Contribution

MAXIDEX is part of Harrow Health's portfolio of FDA-approved products. Harrow Health has seen significant revenue growth, with annual revenues increasing by 232% from $26.7 million to $88.6 million, representing a 35% CAGR. The company's revenue guidance for 2024 remains strong, with expectations of exceeding $180 million, driven partly by the performance of products like MAXIDEX[5].

Financial Performance

In the third quarter of 2024, Harrow Health reported revenues of $49.3 million, a 44% increase over the prior year's third quarter. This growth is attributed to the strategic relaunch of products, including MAXIDEX, and the company's efforts to increase gross margins and revenue from newly launched products[2].

Pricing Strategies

Harrow Health recently announced a price reduction for MAXIDEX and VIGAMOX®, which, while potentially impacting short-term revenues, is part of a broader strategy to enhance market competitiveness and patient access. This move aligns with the company's long-term financial goals and is expected to contribute positively to future revenue growth[2].

Clinical Trials and Regulatory Landscape

The company is planning to initiate a dry eye chamber clinical trial in the first half of 2024, which could lead to the resubmission of a New Drug Application (NDA) in the second half of the year. This initiative underscores the ongoing commitment to expanding the therapeutic indications and improving the market position of MAXIDEX and other ophthalmic drugs[1][4].

Competitive Segment

The anti-VEGF agents segment, which is not directly related to MAXIDEX but is a significant part of the ophthalmic drugs market, held a dominant revenue share of 32.5% in 2023. However, corticosteroids like MAXIDEX remain crucial for treating various inflammatory eye conditions, ensuring a stable market presence[4].

Side Effects and Safety Considerations

MAXIDEX, like other corticosteroids, comes with potential side effects such as ocular hypertension, glaucoma, and cataract formation, especially with prolonged use. These safety considerations are closely monitored by healthcare professionals, and the product's labeling includes detailed warnings and precautions[3].

Market Growth Drivers

• Increasing Prevalence of Eye Disorders: The rise in eye disorders such as dry eye, cataracts, and glaucoma drives the demand for ophthalmic drugs, including MAXIDEX.
• Advancements in Therapeutics: Continuous innovation and the introduction of new therapeutic agents contribute to market growth.
• Regulatory Approvals: FDA approvals and the expansion of therapeutic indications for existing products like MAXIDEX are key drivers.

Financial Projections

Harrow Health is confident about its financial trajectory, with expectations of a record-breaking year in 2025. The company's revenue guidance and strategic initiatives, including the relaunch of products and the focus on FDA-approved products, are set to drive future growth[2].

Key Takeaways

• Market Growth: The U.S. ophthalmic drugs market is growing at a CAGR of 7.4% from 2024 to 2030.
• Revenue Contribution: MAXIDEX is a significant contributor to Harrow Health's revenue, with the company expecting to exceed $180 million in revenue for 2024.
• Pricing Strategies: Recent price reductions aim to enhance market competitiveness and patient access.
• Clinical Trials: Ongoing clinical trials and regulatory initiatives are crucial for expanding the therapeutic indications of MAXIDEX.
• Safety Considerations: Close monitoring of side effects is essential for the safe use of MAXIDEX.

FAQs

Q: What is the current market size of the U.S. ophthalmic drugs market? A: The U.S. ophthalmic drugs market size was estimated at USD 15.53 billion in 2023[4].

Q: What is the projected growth rate of the U.S. ophthalmic drugs market? A: The market is anticipated to grow at a CAGR of 7.4% from 2024 to 2030[4].

Q: What are the primary indications for MAXIDEX? A: MAXIDEX is indicated for steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe[3].

Q: What are the potential side effects of MAXIDEX? A: Potential side effects include ocular hypertension, glaucoma, cataract formation, and other eye-related issues, especially with prolonged use[3].

Q: What are Harrow Health's financial projections for 2024 and beyond? A: Harrow Health expects to exceed $180 million in revenue for 2024 and anticipates a record-breaking year in 2025[2].

Sources

1. Nova One Advisor: US Ophthalmic Drugs Market Size and Growth.
2. Harrow, Inc.: Letter to Stockholders.
3. Health Canada: MAXIDEX Product Monograph.
4. Grand View Research: U.S. Ophthalmic Drugs Market Size | Industry Report, 2030.
5. Harrow Health INC: Form 8-K filed 03/23/2023.