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Last Updated: November 14, 2025

Lindane - Generic Drug Details


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Summary for lindane
US Patents:0
Tradenames:4
Applicants:5
NDAs:12
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 199
Clinical Trials: 1
Drug Prices: Drug price trends for lindane
What excipients (inactive ingredients) are in lindane?lindane excipients list
DailyMed Link:lindane at DailyMed
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Medical Subject Heading (MeSH) Categories for lindane

US Patents and Regulatory Information for lindane

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Reed And Carnrick KWELL lindane CREAM;TOPICAL 006309-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Olta Pharms LINDANE lindane LOTION;TOPICAL 087313-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sola Barnes Hind GAMENE lindane LOTION;TOPICAL 084989-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Reed And Carnrick KWELL lindane SHAMPOO;TOPICAL 010718-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Reed And Carnrick KWELL lindane LOTION;TOPICAL 006309-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wockhardt Bio Ag LINDANE lindane SHAMPOO;TOPICAL 088191-001 Sep 18, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Reed And Carnrick KWELL lindane LOTION;TOPICAL 084218-002 Approved Prior to Jan 1, 1982 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: Lindane

Last updated: July 27, 2025

Introduction

Lindane, chemically known as gamma-hexachlorocyclohexane, is a historically significant pharmaceutical compound primarily used as an insecticide and acaricide. Its medicinal applications have long been overshadowed by safety concerns, leading to regulatory bans and market withdrawal in numerous countries. This comprehensive analysis examines the evolution of Lindane’s market dynamics, the factors influencing its current status, and its future financial trajectory amid regulatory, environmental, and health considerations.


Historical Market Context and Regulatory Shift

Lindane’s entry into pharmaceutical markets was primarily for topical treatment of ectoparasitic infestations, including lice and scabies, particularly in the late 20th century. Its efficacy in combating these conditions made it a staple in dermatological therapeutics. However, mounting scientific evidence raised concerns over its neurotoxicity, environmental persistence, and potential carcinogenicity. Regulatory agencies, notably the U.S. Environmental Protection Agency (EPA) and the European Medicines Agency (EMA), began implementing stringent restrictions.

By the early 2000s, Lindane faced bans or severe restrictions in over 50 countries, culminating in a worldwide trend toward market withdrawal. The WHO classified Lindane as WHO Class I, indicating probable human carcinogenicity, further fueling regulatory caution. These limitations drastically curtailed its legal production and distribution, transitioning Lindane from a widely used pharmaceutical to a largely obsolete compound.


Market Dynamics: Supply, Demand, and Regulatory Pressures

  • Supply Chain Constraints: The decline in Lindane’s legal use caused a substantial reduction in global supply chains. Manufacturers divested or ceased production due to liability risks, environmental citations, and regulatory non-compliance costs. Consequently, the supply became highly constrained, existing primarily through residual inventories or clandestine channels.

  • Demand Fluctuation: Demand for Lindane’s medicinal application has collapsed, largely replaced by safer alternatives such as permethrin, malathion, and ivermectin. These compounds offer comparable efficacy with improved safety profiles, aligning with modern clinical standards and regulatory directives.

  • Regulatory Landscape: Regulatory bodies, particularly in the EU and US, have issued bans on Lindane’s pharmaceutical use. The US FDA prohibited Lindane for medical treatment in 2002, and the EU banned it from medicinal products in 2009. The ongoing enforcement of these bans diminishes the potential for legal resurgence, although illicit markets and imported residues exist in regions with lax enforcement.

  • Environmental and Safety Considerations: Lindane’s persistence in the environment leads to bioaccumulation in aquatic and terrestrial ecosystems, posing threat levels to wildlife and humans. International conventions, such as the Stockholm Convention on Persistent Organic Pollutants, have called for phased elimination of Lindane, further impacting market viability.


Financial Trajectory: Prognosis and Business Implications

Given the stringent regulatory environment and the advent of alternative therapeutics, Lindane’s market valuation is expected to remain in structural decline. Companies with residual inventories face liabilities, and new investments are unlikely due to unresolved safety issues and social licensing constraints.

Current Valuations and Market Outlook:

  • Market Valuation: The residual Lindane market, if any, is measured in the low millions of USD, primarily driven by illicit trade, confiscated stocks, or specialized niche uses in regions with less stringent regulations.

  • Economic Impact on Manufacturers: Major pharmaceutical firms have phased out Lindane production altogether. Smaller, legacy producers or chemical suppliers may still hold limited inventories; however, profitability remains marginal.

  • Potential for Repurposing or Reclassification: Given environmental and safety concerns, there are minimal prospects for Lindane’s reintroduction into mainstream medicine. Research into biodegradation or remediation efforts could potentially open niche markets for environmental cleanup, but these are not directly profitable pharmaceutical avenues.

  • Legal and Litigation Risks: The liability associated with Lindane supports a declining financial trajectory. Multimillion-dollar litigation expenses related to health claims and environmental damages have historically plagued producers and distributors.

Future Market Trends:

  • A continued decline aligned with global regulatory bans and safety concerns.

  • Emergence of alternative treatments reducing demand further.

  • Potential niche or experimental uses in environmental remediation, but these are unlikely to influence overall market traction.


Environmental and Ethical Considerations Impacting Market Trajectory

Regulatory agents, environmental groups, and health authorities collectively enforce a trajectory favoring the phasing out of Lindane. International agreements and national policies coordinate efforts to eliminate its use due to persistent bioaccumulation and toxicity risks. The societal push toward safer, sustainable healthcare products further diminishes prospects for revival.


Conclusion

Lindane’s market dynamics have been profoundly shaped by safety concerns and regulatory restrictions. The compound’s demand has virtually disappeared in the pharmaceutical domain, and its market valuation continues to erode. Future prospects hinge on environmental remediation applications or niche, highly regulated uses, which are unlikely to overturn the overall declining trajectory.

Key Takeaways

  • Regulatory bans have irreversibly curtailed Lindane’s pharmaceutical use worldwide, leading to near-total market withdrawal.

  • Safer alternatives like permethrin and ivermectin have supplanted Lindane, suppressing residual demand.

  • Environmental concerns and international treaties accelerate the phase-out, curbing any potential reemergence.

  • Residual markets are limited, primarily comprising illicit sources or inventory liquidations, with minimal revenues.

  • Future market opportunities are confined to niche applications in environmental remediation, offering little to influence the overall decline.


FAQs

  1. Is Lindane still approved for medical use in any country?
    No, major regulatory bodies such as the US FDA and EU EMA have banned Lindane for medical use due to safety concerns. Some countries with limited regulatory enforcement may still permit its use, but these are exceptions rather than the rule.

  2. What are the main health risks associated with Lindane?
    Lindane has been linked to neurotoxicity, carcinogenic potential, and adverse effects on reproductive health. It bioaccumulates in the environment, posing risks to ecosystems and human populations.

  3. Are there ongoing legal liabilities linked to Lindane?
    Yes, numerous lawsuits and environmental damages claims have been filed against manufacturers and distributors, contributing to declining market viability and increased liabilities.

  4. Can Lindane’s chemical structure be used to develop safer drugs or pesticides?
    While structurally related compounds are explored for various applications, Lindane’s specific toxicity profiles hinder its direct repurposing. Researchers focus more on safer analogs.

  5. Is there any legitimate medicinal or commercial future for Lindane?
    Currently, no. The decline in demand, regulatory restrictions, and safety issues nullify prospects for legitimate medicinal or significant commercial uses in the foreseeable future.


Sources

[1] WHO. "Environmental Health Criteria 124: Gamma-Hexachlorocyclohexane (Lindane)." 1991.
[2] EPA. "Final Rule: Pesticides; Locking up Lindane." 2006.
[3] European Medicines Agency. "Assessment Report on Lindane." 2009.
[4] Stockholm Convention. "Persistent Organic Pollutants Review Committee Report." 2009.
[5] U.S. FDA. "Final Rule: Lindane for Medical Use." 2002.

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