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Last Updated: December 19, 2025

CROLOM Drug Patent Profile


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

Crolom is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in CROLOM 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 Crolom

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

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Summary for CROLOM
Drug patent expirations by year for CROLOM
Recent Clinical Trials for CROLOM

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University of California, San DiegoPhase 1/Phase 2

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US Patents and Regulatory Information for CROLOM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb CROLOM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 074443-001 Jan 30, 1995 DISCN No 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 the Pharmaceutical Drug: Crolom (Aldomethacin)

Last updated: July 30, 2025


Introduction

Crolom, primarily recognized by its generic name alclometasone dipropionate, is a potent topical corticosteroid prescribed for inflammatory skin conditions. While it is not a blockbuster in terms of revenue compared to systemic medications, understanding its market landscape offers insights into niche dermatological therapies and the broader corticosteroid market. This analysis explores market drivers, competitive dynamics, regulatory landscape, and financial projections shaping Crolom's trajectory.


Product Overview and Therapeutic Significance

Crolom, distinguished for its anti-inflammatory, antipruritic, and vasoconstrictive properties, is indicated for atopic dermatitis, psoriasis, and other inflammatory dermatoses. Its formulation as a topical corticosteroid offers localized treatment with minimal systemic absorption, reducing potential side effects. The pharmaceutical efficacy of Crolom has sustained its use over decades, supported by its proven safety profile.

Its position within the corticosteroid market remains stable due to the longstanding clinical acceptance of topical steroids, with Crolom contributing to a segment characterized by a competitive landscape dominated by high-potency steroids and combination formulations.


Market Dynamics

1. Therapeutic Demand and Prescribing Trends

The demand for Crolom correlates with the prevalence of inflammatory skin disorders, which are increasingly diagnosed worldwide. The global prevalence of atopic dermatitis, for instance, affects over 10-20% of children and 2-3% of adults, according to the World Allergy Organization [1], fueling consistent prescription volumes. Dermatologists prefer corticosteroids like Crolom as first-line treatments, especially in acute flare-ups.

However, the shift toward steroid-sparing therapies and biologic agents for severe or refractory dermatitis could moderate future growth prospects. Nonetheless, Crolom's safety and affordability continue to sustain its relevance for mild to moderate cases.

2. Competitive Landscape

Crolom faces competition from multiple corticosteroids, including hydrocortisone, betamethasone, and newer non-steroidal anti-inflammatory topical agents. The market is further fragmented by generic formulations, reducing price points and margins.

Innovative delivery systems such as foam, gel, and liposomal formulations are edging into the space, offering enhanced patient compliance but also creating substitutional pressure. Mergers and acquisitions among dermatology-focused pharma players influence market share and R&D investments.

3. Regulatory Environment

Regulatory bodies like the FDA and EMA maintain rigorous standards for topical corticosteroids, including safety profiles related to steroid potency and systemic absorption risks. Changes in labeling, dosing restrictions, or safety warnings can influence prescribing habits.

Regulatory approvals or re-evaluations of similar drugs may impact Crolom's market positioning, especially if new contraindications or safety concerns emerge.

4. Geographic Markets

North America, Europe, and parts of Asia-Pacific constitute the main markets for Crolom. The mature markets benefit from established prescribing practices but face pricing pressures and generic competition. Emerging markets, characterized by rising dermatitis prevalence and expanding healthcare access, offer growth opportunities, albeit with challenges related to regulatory pathways and affordability.

5. Pricing and Reimbursement

Market access hinges on pricing strategies and reimbursement policies. Governments enforce cost-containment via formularies and tendering, impacting profitability. The availability of generics diminishes pricing power but supports volume-driven sales.


Financial Trajectory Analysis

1. Revenue Forecasting

Given Crolom’s niche status, revenue streams are projected based on regional prescription volumes, penetration rates, and pricing trends. For instance:

  • North America: Steady prescription rates with a slight decline owing to emerging biologics for severe cases but offset by maintenance therapies.
  • Europe: Mature market with stagnant growth, further impacted by strict regulatory policies.
  • Asia-Pacific: Rapid growth potential driven by increasing dermatitis prevalence and expanding healthcare infrastructure.

Assuming a compound annual growth rate (CAGR) of 2-3% in mature markets, and a higher CAGR (approximately 5-7%) in emerging regions, revenues are expected to plateau over the next five years unless significant marketing or formulation innovations occur.

2. Cost Structure and Margins

Manufacturing costs for topical corticosteroids like Crolom are relatively stable due to established production processes. However, R&D expenses for new delivery systems or formulations could increase costs. Margins are squeezed by generic competition but maintained through strategic pricing and volume.

3. Impact of Patent Expiry

Crolom’s patent protections have long expired, leading to generic competition that significantly impacts profitability. Efforts to extend market exclusivity—via formulation patents or secondary patents—are limited but can influence financial trajectories marginally.

4. Investment and Innovation

Investment in new delivery modalities, combination therapies, or biomarker-driven personalization could influence future revenues. While Crolom itself may not be at the innovation forefront, its position within a portfolio of dermatological products could benefit from pipeline developments.


Future Outlook and Strategic Considerations

The outlook for Crolom remains cautiously optimistic within its niche. Key drivers include increasing global dermatitis prevalence, expanding access to dermatological care in emerging markets, and incremental formulation innovations. Challenges stem from generic price competition, evolving regulatory standards, and the emergence of alternative therapies.

To enhance its financial trajectory, pharmaceutical companies might pursue:

  • Strategic positioning in emerging markets with tailored pricing.
  • Development of combination products to reinforce differentiation.
  • Digital health integrations for improved adherence and monitoring.

In conclusion, Crolom’s market remains stable but with limited upside without significant innovation or expansion into new therapeutic areas.


Key Takeaways

  • Stable Niche: Crolom maintains a stable position in topical corticosteroid markets, supported by global dermatological needs.
  • Competitive Pressure: Generic competition and new formulation options exert downward pressure on prices and margins.
  • Regional Growth: Emerging markets present growth opportunities; mature markets face growth stagnation.
  • Innovation Constraints: Patent expirations limit exclusivity, but pipeline innovations can offer future growth paths.
  • Strategic Focus: Geographic expansion, formulation enhancements, and integration with digital health tools are vital for sustaining revenue.

FAQs

1. What factors influence Crolom’s market share in dermatology?
Prescribing patterns driven by clinical efficacy, safety profile, cost, and non-steroidal alternatives significantly influence market share. Emerging therapies and formulatory innovations also impact relative positioning.

2. How does patent expiration affect Crolom’s financial outlook?
Patent expiration allows generic manufacturers to produce lower-cost equivalents, eroding brand-specific revenues and margins, necessitating strategic product differentiation or pipeline diversification.

3. Are there ongoing R&D efforts to improve Crolom?
While no major reforms target Crolom directly, research into new topical delivery systems and combination therapies could indirectly bolster its marketability.

4. What regional factors primarily impact Crolom’s sales?
Regulatory standards, healthcare infrastructure, dermatology prevalence, and reimbursement policies are key regional influences.

5. How does the emergence of biologic therapies affect topical corticosteroids like Crolom?
Biologics are reserved for severe or refractory cases, with corticosteroids retaining prominence for mild to moderate conditions. Overall, biologics complement, rather than replace, topical therapies in the broader treatment landscape.


References

[1] World Allergy Organization. Prevalence of Atopic Dermatitis. 2021.

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