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Last Updated: March 26, 2026

HALOPROGIN - Generic Drug Details


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What are the generic drug sources for haloprogin and what is the scope of freedom to operate?

Haloprogin is the generic ingredient in one branded drug marketed by Westwood Squibb and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for haloprogin.

Summary for HALOPROGIN
US Patents:0
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 38
DailyMed Link:HALOPROGIN at DailyMed

US Patents and Regulatory Information for HALOPROGIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Westwood Squibb HALOTEX haloprogin CREAM;TOPICAL 016942-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Westwood Squibb HALOTEX haloprogin SOLUTION;TOPICAL 016943-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 Haloprogin

Last updated: February 15, 2026

Overview

Haloprogin is an antifungal agent primarily developed for topical treatment of dermatophyte infections, including tinea pedis, tinea corporis, and tinea cruris. It was approved by the FDA in the 1980s but has largely exited the market due to limited demand and the emergence of newer antifungals.

Market Size and Demand

Global antifungal market estimated at $13.7 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 4.7% through 2030 [1]. The market is driven by rising prevalence of fungal infections, increasing awareness, and expanding healthcare access.

Haloprogin's segment accounts for a small niche in topical antifungals, with no recent sales or formulations. Its limited presence results from competition with more effective drugs like terbinafine, clotrimazole, and miconazole.

Competitive Landscape

Major competing drugs include:

  • Terbinafine: Market share >30%; topical formulations approved since early 1990s.

  • Clotrimazole: Long-established over-the-counter (OTC) option; significant market penetration.

  • Miconazole: Similar OTC use; broad-spectrum antifungal.

Newer agents focus on improved tolerability and reduced resistance. The dominance of these drugs leaves minimal space for haloprogin.

Regulatory Status and Patent Landscape

Haloprogin's FDA approval was granted in the 1980s; patent protection has long expired, making it a generic commodity. No recent attempts for new formulation approvals or patent filings have been recorded [2].

Pricing and Reimbursement

No recent pricing data available. Historically, topical antifungals ranged from $10 to $20 per prescription or OTC product. The absence of recent sales indicates that haloprogin is not commercially active or is only available through outdated stocks or compounding.

Financial Trajectory

  • Historical Revenue: Non-quantifiable; no recent sales reported.

  • Current Market Presence: Minimal or none; seen as a legacy treatment, replaced by newer drugs.

  • Potential for Re-entry: Low, unless a novel formulation or new indication is identified.

  • Investment Outlook: Negative, due to obsolescence, patent expiration, and strong competition.

Emerging Opportunities and Challenges

While the core molecule has minimal current interest, potential future pathways include:

  • Reformulation with improved delivery systems (e.g., nanoemulsions).

  • Combination with other agents to address resistant fungal strains.

  • Novel indications based on antifungal or anti-inflammatory properties.

However, R&D costs and regulatory hurdles exceed likely benefits, considering existing competitors' dominance.

Regulatory and Commercial Barriers

  • Entry barriers are high due to established, effective alternatives.

  • Regulatory agencies may require extensive safety data unless pursuing reformulation or new indications.

  • Market saturation limits profitability prospects.

Summarized Financial Outlook

Factor Impact Notes
Market Size Stable, growing slowly Significant demand for topical antifungals
Competition Intense Dominated by terbinafine, clotrimazole, miconazole
Patent Status Expired No exclusivity; generic status
Current Sales None reported Obsolescence or discontinuation
Investment Potential Low Difficult to recapture market share

Key Takeaways

  • Haloprogin is an outdated antifungal with no current commercial activity.

  • The antifungal market is mature, with dominant brands that prevent new entrants from gaining market share without substantial innovation.

  • Reformulation or new indications might create opportunities but require significant R&D investment with uncertain returns.

  • The regulatory and competitive landscape discourages renewed development or commercialization.

FAQs

  1. Is there any ongoing research on haloprogin?
    No active research or development projects related to haloprogin are publicly documented. Its market failure in the 1980s suggests no current interest.

  2. Could reformulating haloprogin revive its market potential?
    Potentially, if reformulation addresses previous limitations and offers a competitive advantage. However, high R&D costs and strong market incumbents make this unlikely to be profitable.

  3. Are there regulatory pathways to reintroduce haloprogin?
    Yes, as a generic drug, it can be reintroduced via supplemental application if safety and efficacy data are generated, but this is unlikely to be pursued given current alternatives.

  4. What are the main competitors to haloprogin?
    Topical antifungals such as terbinafine, clotrimazole, and miconazole dominate the market, sharing most of the consumer and prescription base.

  5. Does the expiration of haloprogin patents open new commercial opportunities?
    Patent expiration allows generic manufacturing but does not translate into profitability without differentiation or new indications.

Citations

[1] Grand View Research. "Antifungal Drugs Market Size, Share & Trends Analysis Report." 2022.
[2] FDA Drugs Database. "FDA Approved Topical Antifungal Drugs." 2022.

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