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Last Updated: December 22, 2024

OCUSULF-10 Drug Patent Profile


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Which patents cover Ocusulf-10, and what generic alternatives are available?

Ocusulf-10 is a drug marketed by Miza Pharms Usa and is included in one NDA.

The generic ingredient in OCUSULF-10 is sulfacetamide sodium. There are three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the sulfacetamide sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ocusulf-10

A generic version of OCUSULF-10 was approved as sulfacetamide sodium by SANDOZ on October 18th, 1988.

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Summary for OCUSULF-10
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 117
Patent Applications: 819
DailyMed Link:OCUSULF-10 at DailyMed
Drug patent expirations by year for OCUSULF-10

US Patents and Regulatory Information for OCUSULF-10

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Miza Pharms Usa OCUSULF-10 sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 080660-001 Approved Prior to Jan 1, 1982 DISCN 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

OCUSULF-10 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OCUSULF-10 and Related Ophthalmic Drugs

Introduction to OCUSULF-10 and Ocular Therapeutix

OCUSULF-10, a product developed by Ocular Therapeutix, is part of the broader ophthalmic drugs market. To understand its market dynamics and financial trajectory, it is essential to delve into the overall ophthalmic drugs market, the performance of Ocular Therapeutix, and specific trends affecting these products.

Ophthalmic Drugs Market Overview

The U.S. ophthalmic drugs market is significant and growing. 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. This growth is driven by an increasing prevalence of eye-related disorders, particularly among the aging population[3].

Key Drivers of the Ophthalmic Drugs Market

  • Aging Population: The steady growth in the aging population in the U.S. is a significant factor, as older adults are more prone to eye-related disorders.
  • Increasing Prevalence of Eye Disorders: Conditions such as glaucoma, dry eye disease, and other vision impairments are becoming more common, driving the demand for ophthalmic drugs.
  • Government and Non-Government Support: Increasing awareness campaigns and support from public and private bodies are expected to boost the sales of prescription ophthalmic drugs[3].

Market Segments and Trends

Prescription vs. Generic Drugs

The prescription drugs segment currently holds the leading revenue share in the ophthalmic market. However, the generic drugs segment is expected to showcase the fastest growth due to the increasing expiry rate of branded drug patents and the cost-effectiveness of generic drugs[3].

Specialty Drugs

Specialty drugs, including those for ophthalmic conditions, have seen significant spending growth. Between 2017 and 2022, total inflation-adjusted expenditures on specialty drugs grew from $226 billion to $316 billion, a 39.9% increase. The spending per specialty prescription increased by 49.2% during this period, indicating a rise in the cost per prescription rather than an increase in the number of prescriptions[1].

Ocular Therapeutix Financial Performance

Revenue and Growth

Ocular Therapeutix (NASDAQ: OCUL) reported a total net revenue of $15.4 million for Q3 2024, representing a minimal growth of 2.3% year-over-year. The company's full-year 2024 revenue guidance for DEXTENZA, one of its key products, is projected between $62.0 and $67.0 million[5].

Cash Position and Operational Funding

As of Q3 2024, Ocular Therapeutix had a cash position of $427.2 million, which is expected to fund operations into 2028. This financial stability is crucial for ongoing research and development, including the Phase 3 SOL-1 trial for AXPAXLI in wet AMD[5].

Net Loss and Financial Health

Despite the revenue growth, Ocular Therapeutix reported a net loss of $36.5 million or $(0.22) per share for Q3 2024. The company's financial health is a mix of positive cash reserves and ongoing operational losses, which is common in the biotech and pharmaceutical sectors where research and development costs are high[5].

Competitive Landscape

Competition in Ophthalmic Drugs

The ophthalmic drugs market is competitive, with various players including branded and generic drug manufacturers. The market is driven by innovation, with new products and therapies being introduced regularly. For instance, the approval of MIEBO prescription eye drops for treating dry eye disease by the FDA in May 2023 highlights the dynamic nature of this market[3].

Impact of Generic Drugs

The increasing expiry rate of branded drug patents and the cost-effectiveness of generic drugs are expected to support the growth of the generic segment. This could pose a challenge to branded drugs like OCUSULF-10, as generic alternatives may attract price-sensitive consumers[3].

Regulatory Environment

FDA Approvals and Regulations

Regulatory approvals are crucial for the success of ophthalmic drugs. The FDA's approval of new treatments, such as MIEBO for dry eye disease, indicates a supportive regulatory environment that encourages innovation in the ophthalmic sector[3].

Future Outlook

Growth Projections

The ophthalmic drugs market is expected to continue growing, driven by demographic changes and the increasing prevalence of eye-related disorders. The availability of new therapies and the expansion of existing product lines will be key factors in this growth[3].

Innovative Therapies

The introduction of innovative therapies, such as those for glaucoma and other eye conditions, will drive spending and usage in the ophthalmic market. Breakthrough therapies launched over the past decade are reshaping patient care, and this trend is expected to continue[4].

Key Takeaways

  • The U.S. ophthalmic drugs market is growing, driven by an aging population and increasing prevalence of eye disorders.
  • Prescription drugs currently dominate the market, but generic drugs are expected to grow faster.
  • Ocular Therapeutix faces a competitive landscape but has a stable cash position to fund ongoing operations.
  • Regulatory approvals and innovative therapies are crucial for market growth.
  • The financial trajectory of OCUSULF-10 and similar products will depend on their competitive positioning, regulatory environment, and market demand.

FAQs

1. What is the current size of the U.S. ophthalmic drugs market?

The U.S. ophthalmic drugs market was estimated at USD 15.53 billion in 2023[3].

2. What is the projected growth rate of the ophthalmic drugs market?

The market is anticipated to grow at a CAGR of 7.4% from 2024 to 2030[3].

3. What are the key drivers of the ophthalmic drugs market?

Key drivers include the aging population, increasing prevalence of eye-related disorders, and support from public and private bodies[3].

4. How is Ocular Therapeutix performing financially?

Ocular Therapeutix reported a total net revenue of $15.4 million for Q3 2024, with a net loss of $36.5 million. The company has a cash position of $427.2 million to fund operations into 2028[5].

5. What are the challenges faced by branded ophthalmic drugs like OCUSULF-10?

Branded drugs face competition from generic alternatives, which are cost-effective and gaining market share due to the expiry of branded drug patents[3].

Sources:

  1. Competition in Prescription Drug Markets, 2017-2022 - ASPE Report
  2. Ocular Therapeutix (Nasdaq:OCUL) - Stock Price, News & Analysis - Simply Wall St.
  3. U.S. Ophthalmic Drugs Market Size | Industry Report, 2030 - Grand View Research
  4. The Global Use of Medicines 2024: Outlook to 2028 - IQVIA
  5. Ocular Therapeutix™ Reports Third Quarter 2024 Results and Business Highlights - Stock Titan

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