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Last Updated: December 22, 2024

MAXITROL Drug Patent Profile


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Summary for MAXITROL
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Recent Clinical Trials for MAXITROL

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SponsorPhase
Brandon Eye Associates, PAPhase 4
Universiti Sains MalaysiaN/A
University of Science MalaysiaN/A

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US Patents and Regulatory Information for MAXITROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050065-002 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Harrow Eye MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 050023-002 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 062341-001 May 22, 1984 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

MAXITROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MAXITROL

Introduction to MAXITROL

MAXITROL is an ophthalmic drug developed and marketed by Harrow Health Inc., a company that has been expanding its portfolio of FDA-approved ophthalmic products. MAXITROL is a combination antibiotic and anti-inflammatory medication used to treat various eye infections and inflammations.

Market Context: Ophthalmic Drugs

The ophthalmic drugs market is experiencing significant growth, driven by several key factors:

  • Increasing Prevalence of Eye Diseases: The aging population and rising awareness about eye diseases are major contributors to the demand for ophthalmic drugs. In the U.S., for instance, over 50 million Americans aged 18 and above reported vision loss, with around four million experiencing significant vision issues even with glasses[3].
  • Technological Advancements: Advances in medical technology and the approval of new drugs, such as anti-VEGF agents, are propelling the market forward. For example, Regeneron Pharmaceuticals' EYLEA HD (aflibercept) was approved for treating wet AMD, wet DME, and diabetic retinopathy[3].
  • Geographical Growth: North America, particularly the U.S., holds a significant share of the ophthalmic drugs market due to high disease prevalence and extensive research and development activities by key players like Alcon, Pfizer Inc, and Bausch and Lomb[1][4].

MAXITROL's Market Position

MAXITROL, being part of Harrow Health Inc.'s portfolio, benefits from the company's strategic initiatives and market presence.

  • Commercial Availability: In June 2022, Harrow Health Inc announced the commercial availability of MAXITROL and IOPIDINE 1% in the United States. This move expanded the company's reach and contributed to its revenue growth[1][4].
  • Competitive Landscape: The ophthalmic drugs market is competitive, with segments like anti-VEGF agents and retinal disorders dominating the revenue share. MAXITROL, as a combination antibiotic and anti-inflammatory, targets a specific niche within this market[3][4].

Financial Performance of Harrow Health Inc.

Harrow Health Inc.'s financial performance provides insights into the potential trajectory of MAXITROL.

  • Revenue Growth: For the third quarter of 2024, Harrow Health Inc reported revenues of $49.3 million, a 44% increase over the prior year’s third quarter. This growth is attributed to the commercial success of their products, including MAXITROL[2].
  • Core Financial Metrics: The company's core gross margin was 80% for the third quarter of 2024, indicating strong profitability from their principal business operations. Adjusted EBITDA was $8.8 million, and the company generated about $3 million in cash flow from operations during the same period[2].
  • Future Projections: Harrow Health Inc expects revenues in the second half of 2024 to significantly outpace those in the first half, with a focus on exceeding their previously issued revenue guidance of greater than $180 million. This optimism is partly due to the relaunch of TRIESENCE® and the expected performance of other products like MAXITROL[2].

Strategic Initiatives and Growth Drivers

Several strategic initiatives and market dynamics are driving the growth of MAXITROL and Harrow Health Inc.

  • Research and Development: The company is focused on leveraging its portfolio of FDA-approved products and selectively taking certain compounds through the traditional FDA-approval process. This includes evaluating the development of several compounds as candidates for FDA approval, which could further bolster MAXITROL's market position[5].
  • Regulatory Environment: New guidelines under the Prescription Drug User Fee Act provide a structured approach to assessing risks and benefits in clinical trials, which can support the development and approval of ophthalmic drugs like MAXITROL[4].
  • Market Expansion: The Asia Pacific region, with its large patient pool and rising disease prevalence, offers significant growth opportunities. Although the treatment rate remains low, strategic initiatives by market players are expected to drive growth in this region, potentially benefiting MAXITROL's global reach[1].

Challenges and Opportunities

While MAXITROL and Harrow Health Inc face several challenges, there are also opportunities for growth.

  • Seasonal Fluctuations: The third quarter revenues are historically lower due to seasonal factors such as vacations by eyecare professionals and their patients. However, Harrow Health Inc has managed to maintain a slight sequential increase over the second quarter of 2024, indicating resilience[2].
  • Generic Drugs Segment: The generic drugs segment is expected to grow rapidly due to the expiry of branded drug patents and the cost-effectiveness of generic drugs. This could present both competition and opportunities for MAXITROL, depending on how Harrow Health Inc navigates this landscape[3].

Key Takeaways

  • Market Growth: The ophthalmic drugs market, including MAXITROL, is expected to grow significantly, driven by an aging population and increasing prevalence of eye diseases.
  • Financial Performance: Harrow Health Inc's revenue growth and strong core financial metrics indicate a positive trajectory for MAXITROL.
  • Strategic Initiatives: Focus on FDA-approved products, research and development, and market expansion strategies are key drivers for MAXITROL's success.
  • Challenges and Opportunities: Managing seasonal fluctuations and navigating the generic drugs segment are crucial for sustained growth.

FAQs

Q: What is MAXITROL used for? A: MAXITROL is a combination antibiotic and anti-inflammatory medication used to treat various eye infections and inflammations.

Q: Who is the manufacturer of MAXITROL? A: MAXITROL is manufactured and marketed by Harrow Health Inc.

Q: What is the current market size of the ophthalmic drugs market? A: The global ophthalmic drugs market was valued at USD 33.31 billion in 2023 and is expected to reach USD 60.75 billion by 2031[1].

Q: What are the key growth drivers for the ophthalmic drugs market? A: Key growth drivers include an increasing prevalence of eye diseases, technological advancements, and strategic initiatives by market players.

Q: How does Harrow Health Inc's financial performance impact MAXITROL? A: Harrow Health Inc's revenue growth and strong core financial metrics indicate a positive financial trajectory for MAXITROL, supporting its market presence and expansion.

Cited Sources

  1. Ophthalmic Drugs Market Report, Size, Share & Forecast 2031 - SkyQuestT
  2. Letter to Stockholders - Investor Relations | Harrow, Inc. - Harrow Health Inc.
  3. U.S. Ophthalmic Drugs Market Size | Industry Report, 2030 - Grand View Research
  4. Ophthalmic Drugs Market Demand and Growth Analysis ... - BioSpace - BioSpace
  5. Form 8-K for Harrow Health INC filed 03/23/2023 - Harrow Health Inc.

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