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Last Updated: December 12, 2025

OPHTHETIC Drug Patent Profile


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When do Ophthetic patents expire, and when can generic versions of Ophthetic launch?

Ophthetic is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in OPHTHETIC is proparacaine hydrochloride. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.

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Summary for OPHTHETIC
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 83
Patent Applications: 904
DailyMed Link:OPHTHETIC at DailyMed
Drug patent expirations by year for OPHTHETIC

US Patents and Regulatory Information for OPHTHETIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan OPHTHETIC proparacaine hydrochloride SOLUTION/DROPS;OPHTHALMIC 012583-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Ophthalmic Pharmaceuticals

Last updated: August 5, 2025


Introduction

The ophthalmic pharmaceutical sector is an integral component of the broader healthcare landscape, addressing a critical need across global populations for the treatment of visual impairments and eye-related conditions. With an increasing prevalence of diseases such as glaucoma, age-related macular degeneration (AMD), diabetic retinopathy, and dry eye syndrome, the ophthalmic drug market exhibits significant growth potential. This analysis delves into the current market dynamics and forecasts the financial trajectory of ophthalmic pharmaceuticals, emphasizing key drivers, challenges, and investment opportunities shaping this sector.


Market Overview

The ophthalmic drugs market is projected to reach approximately USD 16.4 billion by 2027, expanding at a Compound Annual Growth Rate (CAGR) of around 4-5% during 2022–2027 [1]. The growth reflects both the rising incidence of eye disorders and advances in drug development, notably in biologics and innovative delivery systems.

Major players, including Novartis, Allergan (AbbVie), Bausch + Lomb, and Regeneron Pharmaceuticals, dominate a landscape characterized by rapid R&D activity and strategic alliances to broaden product pipelines. The market's composite segments include anti-infectives, intraocular anti-VEGF agents, steroids, glaucoma medications, and dry eye treatments.


Key Market Drivers

1. Aging Population and Increasing Disease Burden

Globally, the aging demographic is a primary catalyst, with cataracts, glaucoma, AMD, and diabetic retinopathy predominantly affecting older adults [2]. The World Health Organization estimates that by 2050, the number of individuals over 60 will reach 2 billion, intensifying demand for effective ophthalmic therapies.

2. Technological Innovations and R&D Advances

Innovations such as sustained-release drug delivery systems, gene therapies, and biologics are transforming treatment paradigms. The development of intravitreal anti-VEGF agents for AMD, diabetic retinopathy, and retinal vein occlusion exemplifies this trend, offering targeted and minimally invasive therapeutic options.

3. Rising Prevalence of Diabetes and Chronic Diseases

Diabetes-related eye complications have surged globally, especially in developing countries, fueling demand for anti-VEGF drugs and other therapies [3]. The expanded use of combination therapies and personalized medicine approaches further enhance market growth.

4. Increasing Awareness and Screening Programs

Enhanced screening, early diagnosis, and awareness campaigns promote earlier intervention, leading to increased prescriptions of ophthalmic drugs. Governments and NGOs' initiatives in ophthalmology are contributing significantly to this trend.


Market Challenges

1. High Cost of Innovative Therapies

Biologics and gene therapies often incur high development and manufacturing costs, translating into expensive treatments for consumers and healthcare systems, potentially limiting access and reimbursement.

2. Regulatory Complexities and Approval Delays

Stringent regulatory pathways, especially for biologics and gene therapies, impact product launch timelines and market entry strategies, posing hurdles for rapid commercialization.

3. Market Saturation and Competitive Pressures

The high R&D costs and limited pipeline diversification have led to intense competition, especially in anti-VEGF and glaucoma segments, pressuring pricing and profit margins.

4. Access Disparities in Emerging Markets

Limited healthcare infrastructure in regions like Africa and parts of Asia constrains market expansion, despite increasing disease prevalence.


Financial Trajectory and Investment Outlook

The financial prospects of ophthalmic pharmaceuticals are shaped by ongoing R&D investments, regulatory environments, and market expansion strategies. Companies focusing on innovations—particularly sustained-release formulations, gene editing, and personalized treatments—are expected to see accelerated revenue growth.

Revenue Growth Drivers

  • Anti-VEGF Therapies: Leading revenue generators, with companies like Novartis (Lucentis), Regeneron (Eylea), and Roche (Avastin) capitalizing on widespread AMD and diabetic retinopathy markets.
  • Dry Eye and Ocular Surface Disease Drugs: Projected to expand as awareness grows, with therapies like lifitegrast and cyclosporine eye drops.
  • Emerging Gene and Cell Therapies: These address rare but severe inherited retinal diseases, with several candidates in late-stage trials promising premium pricing and high margins.

Forecasted Revenue Trends

The anti-infective and anti-glaucoma segments maintain steady revenue streams, but the most promising financial upside lies in biologics and personalized medicine. The market for gene therapy in ophthalmology is poised to grow substantially, potentially exceeding USD 3 billion annually by 2030, reflecting the success of companies like Spark Therapeutics and REGENXBIO.

Investment Risks and Opportunities

While the sector offers lucrative prospects, risks include regulatory hurdles, high R&D costs, and reimbursement challenges. Conversely, collaborations, acquisitions, and licensing agreements are prevalent strategies to mitigate risks and accelerate growth. Investors should prioritize compounds with validated clinical efficacy, differentiated delivery modalities, and strong patent protections.


Emerging Trends Shaping the Financial Future

  • Personalized Medicine: Tailoring treatments based on genetic markers enhances efficacy, reduces adverse effects, and commands premium pricing.
  • Digital Health Integration: Use of AI and telemedicine for diagnosis and monitoring enhances patient engagement and adherence, improving treatment outcomes.
  • Sustainable Manufacturing: Focus on cost reduction through improved manufacturing efficiencies stabilizes margins amid competitive pressures.

Geographical Market Dynamics

Developed Markets

North America and Europe remain dominant, driven by high healthcare expenditure, advanced infrastructure, and reimbursement frameworks. Market maturity facilitates adoption of innovative therapies but also intensity in competitive rivalry.

Emerging Markets

Asia-Pacific, Latin America, and the Middle East represent expanding opportunities owing to rising disease burden, improving healthcare access, and increasing patient awareness. Major growth drivers include India, China, and Brazil, where investments in healthcare infrastructure facilitate market penetration.


Regulatory Environment

Regulatory agencies such as the FDA and EMA influence product development timelines and approval conditions. Recent shifts toward expedited pathways, including Breakthrough Therapy and Priority Review designations, accelerate bringing novel treatments to market. Nonetheless, global variances in approval processes necessitate regional strategies for pharmaceutical companies.


Conclusion

The ophthalmic pharmaceutical industry exhibits robust growth prospects driven by demographic shifts, technological advancements, and an expanding disease burden. While challenges such as high R&D costs and regulatory complexities persist, the sector's innovation pipeline, particularly in biologics and gene therapy, promises substantial financial returns.

Strategic investment in emerging therapies, especially personalized and gene-based treatments, positions stakeholders to capitalize on future market expansions. Meanwhile, addressing access disparities, fostering collaborations, and navigating regulatory landscapes effectively will be crucial to sustained financial success.


Key Takeaways

  • Demographic trends are primary growth drivers, with aging populations increasing demand for ophthalmic therapies.
  • Innovations in biologics, gene therapies, and sustained-release systems are transforming treatment options and revenue streams.
  • Anti-VEGF agents dominate current revenue, but upcoming therapies in gene and personalized medicine offer significant upside potential.
  • Market expansion is significant in emerging regions, despite access and infrastructure barriers.
  • Regulatory agility and strategic collaborations are vital for rapid commercialization and maintaining competitive advantage.

FAQs

1. What are the main segments within the ophthalmic pharmaceutical market?
The primary segments include anti-infectives, intraocular anti-VEGF agents, corticosteroids, glaucoma medications, and treatments for dry eye syndrome.

2. How are emerging therapies like gene editing impacting the sector?
Gene therapies target previously untreatable or rare ocular conditions, offering potential cures and high-margin products, thereby redefining the financial landscape.

3. What factors could slow market growth?
High treatment costs, regulatory delays, market saturation, and limited access in emerging economies pose challenges to sustainable expansion.

4. Which regions are expected to see the highest growth?
Asia-Pacific and Latin America are anticipated to experience significant growth due to increasing disease burden and healthcare investments.

5. How does technological innovation influence investment opportunities?
Innovations improve efficacy and patient outcomes, increasing availability of premium-priced therapies, and attracting investor interest in R&D-driven companies.


References

[1] MarketsandMarkets. "Ophthalmic Drugs Market by Product, Disease Type, and Region—Forecast to 2027," 2022.
[2] WHO. "Vision and Eye Health," 2021.
[3] IDF Diabetes Atlas, 9th Edition, 2019.

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