Last Updated: June 9, 2026

Pyrithione zinc - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for pyrithione zinc and what is the scope of patent protection?

Pyrithione zinc is the generic ingredient in one branded drug marketed by Warner Chilcott and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for pyrithione zinc
Drug Prices for pyrithione zinc

See drug prices for pyrithione zinc

Recent Clinical Trials for pyrithione zinc

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Second Affiliated Hospital of Xi'an Jiaotong UniversityPHASE4

See all pyrithione zinc clinical trials

US Patents and Regulatory Information for pyrithione zinc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott HEAD & SHOULDERS CONDITIONER pyrithione zinc LOTION;TOPICAL 019412-002 Mar 10, 1986 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
Last updated: February 14, 2026

What is the current market landscape for Pyrithione Zinc?

Pyrithione Zinc is primarily used as an active ingredient in anti-dandruff shampoos, scalp treatments, and other dermatological products. It is recognized for its antimicrobial and antifungal properties, targeting conditions like dandruff, seborrheic dermatitis, and scalp psoriasis.

The global market for Pyrithione Zinc fell under the umbrella of dandruff and scalp therapies. As of 2022, the market was valued at approximately USD 1.2 billion, with projections to reach USD 1.6 billion by 2028, growing at a compound annual growth rate (CAGR) of about 4.8%. Growth is driven by increasing consumer awareness regarding hair health, expanding product portfolios, and rising demand in emerging markets.

Who are the key players in the Pyrithione Zinc market?

Major companies involved include:

  • Unilever
  • Procter & Gamble
  • Johnson & Johnson
  • Merck KGaA
  • DOW Chemicals

These firms hold significant market shares due to their extensive distribution networks and brand recognition in personal care products. Recent partnerships and acquisitions focus on developing novel formulations and expanding into dermatology segments beyond scalp health.

How does supply chain impact market stability?

Supply is concentrated among suppliers of raw materials, with Pyrithione Zinc primarily produced via synthesis pathways involving zinc salts and organic compounds. Good manufacturing practices (GMP) and regulatory compliance (e.g., US FDA, European Cosmetics Regulation) influence production costs and supply consistency.

Any regulation tightening or raw material shortages, such as disruptions in zinc mining, could impact manufacturing capacity and pricing. Trade tensions or tariffs involving key zinc-producing nations could also alter supply chain stability.

What are the regulatory considerations affecting market growth?

Regulatory frameworks governing Pyrithione Zinc include:

  • US FDA: approved for OTC hair care products
  • EU Cosmetics Regulation: approves Pyrithione Zinc within specified concentrations (up to 2%)
  • Japan's Ministry of Health, Labour and Welfare: permits use within cosmetics

Changes in regulatory limits, re-evaluation of safety profiles, or bans could significantly hinder market prospects. Recent scientific reviews have focused on the compound's safety, with some organizations calling for stricter concentration limits or transparency requirements.

What are the emerging trends and R&D trajectories?

Research focuses on:

  • Developing alternative formulations with lower zinc concentrations while maintaining efficacy
  • Combining Pyrithione Zinc with other active ingredients for broader dermatological applications
  • Exploring biodegradable or more environmentally friendly production methods

Innovation is driven by consumer preferences for natural or clean-label products, regulatory scrutiny, and the desire for enhanced efficacy with minimal side effects.

What are the financial risks and opportunities?

Risks:

  • Regulatory tightening reducing permissible concentrations
  • Competition from new active ingredients (e.g., climbazole, selenium sulfide)
  • Raw material price fluctuations due to zinc supply constraints

Opportunities:

  • Expansion into new dermatological indications
  • Formulation innovations targeting specific demographic segments (e.g., men, ethnic groups)
  • Geographical expansion into emerging markets with growing hair care consumption

How do financial trajectories look for companies involved?

Large players report steady revenue streams from Pyrithione Zinc-containing products. For example, Unilever's scalp care segment grew by approximately 3–5% annually, largely driven by anti-dandruff products. Margins are influenced by raw material costs; price increases in zinc or organic synthesis intermediates could pressure margins if not passed downstream.

Private label and new entrants are attempting to capture market share through lower-cost formulations or organic claims. Companies investing in R&D for new delivery systems (e.g., sprays, serums) aim to maintain competitive edges.

What is the outlook for market growth?

The overall market is expected to grow at a CAGR of nearly 4.8% through 2028. Growth may slow if regulatory restrictions tighten or if consumer preferences shift toward alternative products. Nonetheless, expanding personal care markets in Asia-Pacific and Latin America offer continued growth opportunities.

Key Takeaways

  • Pyrithione Zinc's market is valued at USD 1.2 billion (2022), projected to reach USD 1.6 billion by 2028.
  • Dominant companies include Unilever, P&G, and Johnson & Johnson, holding leading shares.
  • Supply chain stability depends on zinc raw material imports, with potential risks from geopolitical and environmental factors.
  • Regulatory environments largely permit use within specified limits but are subject to re-evaluation.
  • Innovation centers on formulation improvements and environmentally friendly manufacturing.
  • Market growth persists despite potential regulation-driven stagnation, supported by demographic and geographic expansion.

FAQs

1. How does regulatory scrutiny impact Pyrithione Zinc’s market?
Regulatory agencies periodically review safety data for Pyrithione Zinc. Stricter concentration limits or bans could reduce its usage, impacting sales.

2. Are there substitutes for Pyrithione Zinc in anti-dandruff products?
Yes. Alternatives include climbazole, selenium sulfide, and ketoconazole, which compete based on efficacy, safety, and consumer preferences.

3. What is the potential for new dermatology applications?
Emerging research explores uses in psoriasis, seborrheic dermatitis, and scalp skin infections, which could diversify revenue streams.

4. How susceptible is the market to zinc supply disruptions?
While supply chain disruptions could raise costs, the widespread availability of zinc and global sourcing mitigate long-term risks.

5. What regulatory developments could influence future growth?
Changes in permissible concentrations, safety re-evaluations, or labeling requirements could alter market dynamics, possibly favoring formulations with lower zinc content.


References

[1] Market Research Future. “Global Pyrithione Zinc Market Analysis.” 2022.
[2] Grand View Research. “Personal Care Market Trends & Forecasts.” 2023.
[3] European Commission. “Cosmetics Regulation (EC) No 1223/2009.” 2022.
[4] US FDA. “Over-the-Counter Drug Monographs.” 2023.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.