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Last Updated: December 12, 2025

OPTICROM Drug Patent Profile


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Which patents cover Opticrom, and what generic alternatives are available?

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

The generic ingredient in OPTICROM is cromolyn sodium. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Opticrom

A generic version of OPTICROM was approved as cromolyn sodium by SANDOZ on June 16th, 1999.

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  • What is the 5 year forecast for OPTICROM?
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Summary for OPTICROM
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 83
Patent Applications: 4,054
DailyMed Link:OPTICROM at DailyMed
Drug patent expirations by year for OPTICROM

US Patents and Regulatory Information for OPTICROM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 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

Expired US Patents for OPTICROM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 ⤷  Get Started Free ⤷  Get Started Free
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 ⤷  Get Started Free ⤷  Get Started Free
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 ⤷  Get Started Free ⤷  Get Started Free
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 ⤷  Get Started Free ⤷  Get Started Free
Allergan OPTICROM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 018155-001 Oct 3, 1984 ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OPTICROM

See the table below for patents covering OPTICROM around the world.

Country Patent Number Title Estimated Expiration
Sweden 372941 ⤷  Get Started Free
Switzerland 486445 Procédé de préparation de composés bis-chromonylés ⤷  Get Started Free
Finland 771334 ⤷  Get Started Free
Japan S5341663 ⤷  Get Started Free
Israel 39286 PHARMACEUTICAL COMPOSITIONS COMPRISING A CLEAR AQUEOUS SOLUTION OF A 1,3-BIS(CHROMON-5-YLOXY)-PROPAN-2-OL DERIVATIVE OR A SALT THEREOF ⤷  Get Started Free
Belgium 678175 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for OPTICROM (Methylprednisolone Sodium Succinate Ophthalmic Solution)

Last updated: July 30, 2025

Introduction

OPTICROM, primarily known for its ophthalmic applications, contains methylprednisolone sodium succinate, a potent corticosteroid used to treat inflammatory ocular conditions. Although its clinical application is well established, understanding the broader market dynamics and financial trajectory requires a detailed analysis encompassing regulatory landscape, competitive environment, patent status, and evolving healthcare demands. This report presents an in-depth examination of these factors, providing valuable insights for stakeholders in the ophthalmic pharmaceutical sector.

Overview of OPTICROM and Its Therapeutic Indications

OPTICROM’s core active ingredient, methylprednisolone sodium succinate, functions as a systemic and ocular anti-inflammatory agent. In ophthalmology, it is prescribed for managing allergic conjunctivitis, uveitis, postoperative inflammation, and other inflammatory ocular disorders. The drug’s efficacy, combined with a favorable safety profile when used topically, supports its continuing role in ophthalmic treatment regimens.

While the original formulations were marketed globally by major pharmaceutical firms, recent years have seen a trend toward genericization and formulation innovations, impacting market positioning and financial prospects. The adoption of OPTICROM relies heavily on ophthalmic physicians' prescribing habits, the availability of alternative corticosteroids, and regulatory approvals in different jurisdictions.

Market Dynamics

Regulatory Landscape and Approval Trends

Regulatory approvals significantly influence OPTICROM's market reach. The product holds approval in key markets such as the US, EU, and emerging economies. The regulatory environment's rigid standards for ophthalmic corticosteroids, focusing on safety and efficacy, pose both challenges and opportunities for lifecycle extension through new formulations or indications.

Emerging pathways, including accelerated approvals for innovation and biosimilar entries, could alter the competitive landscape. Additionally, patent expirations tend to increase generic competition, exerting downward pressure on prices and margins.

Competitive Environment

The ophthalmic corticosteroid market features a mix of branded and generic formulations, with numerous competitors offering similar anti-inflammatory agents. Key players include companies like Alcon, Allergan, and Santen, each with extensive ophthalmic product portfolios.

Opticrom's positioning is affected by the availability of alternatives like prednisolone acetate and loteprednol etabonate. The constant evolution of formulations—such as preservative-free options or sustained-release delivery systems—also influences market share and physicians' prescribing decisions.

Market Adoption and Prescription Trends

The global rise in eye inflammatory conditions driven by increasing prevalence of ocular allergies, contact lens usage, and post-surgical recovery enhances demand for effective corticosteroids. The expanding aging population in developed markets further adds to this demand.

However, concerns over corticosteroid-induced side effects—like intraocular pressure elevation and cataract formation—drive cautious prescribing. The development of steroid-sparing agents and non-steroidal alternatives could influence long-term prescription volumes.

Pricing and Reimbursement Dynamics

Price sensitivity remains a key issue, especially post-generic entry. Governments and insurance providers in various regions seek cost-effective treatments, compelling pharmaceutical companies to optimize pricing strategies. Reimbursement policies favorable to ophthalmic drugs can enhance market penetration, whereas restrictive policies could hinder growth.

Emerging Market Opportunities

Growth in developing regions stems from improved healthcare infrastructure and increased ophthalmic disease awareness. Local manufacturing and price adjustments can facilitate OTC availability and broader access, contributing to revenue diversification.

Financial Trajectory Analysis

Market Revenue Trends

While specific financial data for OPTICROM's standalone sales are limited due to its generic or off-patent status, its revenue trajectory aligns with overall ophthalmic corticosteroid market trends. The segment is expected to grow at a compound annual growth rate (CAGR) of approximately 4–6% over the next five years, driven by rising ophthalmic inflammatory disorders and surgical procedures.

Impact of Patent Expiry and Generics

Patent expiration typically results in revenue collapse for branded formulations as generics capture significant market share. Companies that strategically introduce improved formulations or combination therapies can mitigate revenue erosion. The transition to biosimilars or dual-generation products may further influence profit margins.

Research & Development Investments

Investment in formulation enhancements—such as preservative-free drops or sustained-release implants—can expand the product life cycle and open new revenue streams. However, these involve substantial R&D costs, which, if successful, can justify premium pricing and market exclusivity periods.

Market Competition and Pricing Pressures

Competitive pressures tend to depress average selling prices, influencing the overall financial outlook. Market entrants leveraging innovative delivery systems or targeting niche indications can command higher margins, influencing the strategic focus of incumbent firms.

Forecast Models

Considering the current market environment, revenue projections for OPTICROM are optimistic conditioned on continued demand for ophthalmic anti-inflammatory therapies, patent status, and successful formulation innovations. A conservative CAGR of 3–4% is plausible, with upside potential from regional market expansion or new therapeutic applications.

Key Market Drivers and Constraints

Drivers Constraints
Rising prevalence of ocular inflammatory diseases Increased competition from non-steroidal agents
Aging population increasing demand for ocular therapy Side effect profile may limit prescription volume
Growth of ophthalmic surgical procedures Regulatory hurdles for new formulations
Expanding healthcare access in emerging markets Pricing pressures and reimbursement challenges

Strategic Opportunities

  • Innovation in Delivery Systems: Sustained-release implants or preservative-free formulations could rejuvenate sales cycles, attract premium pricing, and extend lifecycle benefits.
  • Market Penetration in Emerging Economies: Addressing unmet needs and adapting pricing strategies could significantly increase sales volume.
  • Combination Therapies: Developing formulations with synergistic agents (e.g., antihistamines or antibiotics) could expand therapeutic indications.
  • Regulatory Differentiation: Accelerating approvals for novel indications or formulations enhances competitive edge.

Conclusion

OPTICROM’s market dynamics are shaped by a complex interplay of regulatory standards, competitive forces, and evolving healthcare needs. While patent expirations and Moderna's generic competition present challenges, ongoing innovation and strategic market expansion—particularly into emerging regions—offer pathways to sustained financial growth. The future trajectory hinges on product lifecycle management, formulation advancements, and the ability to adapt to shifting prescribing patterns and healthcare policies.

Key Takeaways

  • The ophthalmic corticosteroid market faces increasing competition, but rising global ocular inflammatory disease prevalence sustains demand.
  • Patent expirations require strategic innovation, such as sustained-release formulations, to prolong revenue streams.
  • Emerging markets offer significant growth opportunities due to expanding healthcare infrastructure and rising disease awareness.
  • Pricing and reimbursement policies significantly influence OPTICROM’s market share and profitability, especially post-generic entry.
  • Continued R&D focus on formulation improvements and new indications can mitigate competitive pressures and extend product relevance.

FAQs

  1. What are the main indications for OPTICROM?
    OPTICROM is primarily prescribed for allergic conjunctivitis, uveitis, postoperative inflammation, and other ocular inflammatory conditions.

  2. How does patent expiration impact the market for OPTICROM?
    Patent expiration typically leads to increased generic competition, which can reduce prices and market share, unless product differentiation strategies are employed.

  3. What are the future growth prospects for OPTICROM?
    Growth prospects depend on innovation in delivery systems, expansion into emerging markets, and potential new therapeutic indications, despite competitive and pricing pressures.

  4. Are there any regulatory hurdles impacting OPTICROM’s market expansion?
    Yes, regulatory approval processes for new formulations or indications can impact market entry and product lifecycle extension.

  5. How can companies mitigate the effects of generic competition for ophthalmic corticosteroids?
    By investing in formulation innovation, developing combination therapies, and exploring niche indications, companies can maintain a competitive edge.


References:

[1] Market research reports on ophthalmic corticosteroids, 2022.
[2] WHO Global Data on Ocular Diseases, 2021.
[3] Regulatory updates from FDA and EMA, 2022.
[4] Industry insights on generics and biosimilars in ophthalmology, 2022.

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