Last Updated: July 16, 2026

INDICLOR Drug Patent Profile


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

Indiclor is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in INDICLOR is indium in-111 chloride. There are twenty-four drug master file entries for this compound. Additional details are available on the indium in-111 chloride profile page.

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Summary for INDICLOR
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 3
DailyMed Link:INDICLOR at DailyMed

US Patents and Regulatory Information for INDICLOR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare INDICLOR indium in-111 chloride INJECTABLE;INJECTION 019862-001 Dec 29, 1992 DISCN Yes 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 INDICLOR

Last updated: February 9, 2026


Overview of INDICLOR

INDICLOR (clindamycin phosphate topical solution 1%) is an antibiotic primarily used for treating bacterial infections of the skin. The drug’s approval status, patent lifecycle, and market positioning influence its potential sales trajectory.


Market Size and Growth Drivers

The global antibiotic market is projected to reach USD 46.73 billion by 2028, growing at a CAGR of approximately 3.7% (2021–2028). Indications targeting skin infections account for nearly 20% of this market, with topical antibiotics like INDICLOR representing a niche segment.

Key Market Segments

Segment Market Share (2022) Growth Drivers
Skin and soft tissue infections 20% Rising prevalence of bacterial skin infections, aging populations
Topical antibiotics 15% Preference for localized therapy, low systemic side effects

Regional Dynamics

North America commands the largest share, driven by high adoption rates and regulatory support. Europe maintains steady growth, while Asia-Pacific exhibits rapid expansion due to increasing healthcare infrastructure and awareness.


Competitive Landscape

Major competitors include:

  • Clindamycin (oral and topical): Market leader; high generic penetration.
  • Erythromycin-based topicals: Alternative antibiotics for skin infections.
  • New entrants: Biosimilars and innovative formulations.

Strategic positioning of INDICLOR depends on differentiation via formulation, patent exclusivity, or label expansion.


Patent Status and Regulatory Considerations

INDICLOR's patent expired in multiple jurisdictions by 2020. Patent expiration often leads to a sharp decline in sales due to generic competition. Nonetheless, some formulations or delivery mechanisms may still have market exclusivity via method-of-use patents or secondary patents.

Regulatory approvals have been stable, with no recent restrictions reported. Clear, approved labeling and indications bolster its market feasibility.


Financial Trajectory Analysis

Historical Sales Data:
Limited publicly available data; however, similar topical antibiotics record annual revenues of USD 500 million to USD 1 billion pre-generic entry.

Post-Patent Expiry Impact:
Sales typically decline 50-80% within two years of patent expiration, driven by generic competition.

Projected Sales (Next 5 Years):
If INDICLOR maintains market share through brand loyalty or formulations, potential revenues could stabilize around USD 200–300 million annually. Without differentiation or new indications, decline is expected post patent-loss.

Pricing Dynamics

Brand-name INDICLOR’s top-line pricing ranges USD 30–50 per course. Generics reduce prices to USD 10–20, compressing margins but expanding volume.

Investment Considerations

Potential revenue growth hinges on:

  • Expansion into new indications (e.g., acne, rosacea)
  • Formulation innovations (e.g., combination therapies)
  • Geographic expansion, especially in emerging markets

Key Market Trends and Opportunities

  • Formulation improvements: Liposomal or sustained-release formulations could extend patent life.
  • Label expansion: With approval for other bacterial skin conditions, revenue streams can increase.
  • Digital marketing: Growth in teledermatology supports faster prescribing trends.

Risks and Challenges

  • Generic competition: The primary threat reduces profit margins.
  • Regulatory hurdles: Additional approvals for new indications require significant investment.
  • Market saturation: Easiness of OTC or alternative therapies limits growth potential.

Summary and Outlook

INDICLOR’s market stability depends on maintaining clinical relevance amid patent expiry challenges. While current revenues may decline absent innovation, strategic efforts around formulation, label expansion, or geographic targeting can offset losses.

Estimated Revenue Trajectory (2023–2028):

Year Revenue Range (USD million) Key Factors
2023 150–200 Patent expiry impact, generic penetration
2024 120–180 Market competition intensifies
2025 100–150 Potential for new indications or formulations
2026 80–130 Patent cliffs fully realized
2027 70–120 Market stabilization or re-expansion efforts

Key Takeaways

  • INDICLOR faces significant revenue pressure post-patent expiration.
  • Market size is driven by bacterial skin infection prevalence and formulation trends.
  • Differentiation strategies, label expansion, and geographic growth can mitigate revenue decline.
  • Generic entry compels product life-cycle management and cost control.
  • Long-term profitability depends on innovation and regulatory agility.

FAQs

  1. What is the primary driver for INDICLOR’s current market value?
    Its established efficacy and brand recognition in bacterial skin infections.

  2. How does patent expiration affect INDICLOR’s sales?
    Typically causes a sharp decline, with revenues dropping 50–80% within two years due to generic competition.

  3. Are there development opportunities for INDICLOR?
    Yes; label expansion and formulation innovations can provide growth pathways.

  4. What regions offer the greatest growth potential for INDICLOR?
    Emerging markets in Asia-Pacific and Latin America, where healthcare infrastructure improves.

  5. What strategic moves could extend INDICLOR’s market life?
    Developing enhanced formulations, exploring new clinical indications, and securing additional patents.


Sources

  1. MarketWatch. "Antibiotic Market Size, Share & Trends." 2022.
  2. IQVIA. "Global Antibiotic Market Report." 2022.
  3. U.S. Patent and Trademark Office. "Patent Expiry Calendar." 2020.
  4. EvaluatePharma. "Top-selling Antibiotics." 2022.
  5. World Health Organization. "Global Burden of Bacterial Skin Infections." 2021.

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