You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 19, 2026

AMMONIUM CHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Ammonium Chloride is a drug marketed by Abbott, Gd Searle Llc, Mcgaw, B Braun, and Hospira. and is included in five NDAs.

The generic ingredient in AMMONIUM CHLORIDE is ammonium chloride. There are forty drug master file entries for this compound. Additional details are available on the ammonium chloride profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for AMMONIUM CHLORIDE?
  • What are the global sales for AMMONIUM CHLORIDE?
  • What is Average Wholesale Price for AMMONIUM CHLORIDE?
Summary for AMMONIUM CHLORIDE
US Patents:0
Applicants:5
NDAs:5

US Patents and Regulatory Information for AMMONIUM CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott AMMONIUM CHLORIDE ammonium chloride INJECTABLE;INJECTION 083130-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun AMMONIUM CHLORIDE 2.14% ammonium chloride INJECTABLE;INJECTION 085734-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Gd Searle Llc AMMONIUM CHLORIDE ammonium chloride INJECTABLE;INJECTION 086205-001 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

Ammonium chloride (NH4Cl) — Investment Scenario and Fundamentals Analysis

Last updated: February 3, 2026

Overview

Ammonium chloride is an inorganic salt primarily used in pharmaceuticals, industrial manufacturing, fertilizers, and as a food additive. In pharmaceuticals, it functions as an expectorant and a component in formulations for metabolic acidosis or urinary alkalization.

Market Size and Demand Drivers

Global ammonium chloride market was valued at approximately $850 million in 2022, with a compound annual growth rate (CAGR) of about 4.2% projected through 2027 [1]. Growth is driven by increasing demand in fertilizer production, pharmaceuticals, and industrial applications.

Key demand segments include:

  • Pharmaceuticals: Used as an expectorant and in-vitro diagnostic reagents.
  • Agriculture: Application in fertilization, especially in acidic soils.
  • Industry: Usage in textile, metal processing, and food additive sectors.

Supply Chain and Production

Major production occurs via the reaction of ammonium hydroxide with hydrogen chloride:

NH4OH + HCl → NH4Cl + H2O

Global production capacity centers in China, India, and the United States, with China accounting for approximately 60% of supply.

Supply chain vulnerabilities include reliance on crude salt, environmental regulations affecting production, and geopolitical factors impacting trade.

Regulatory Environment

In the pharmaceutical context, ammonium chloride must meet standards set by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Requirements include Good Manufacturing Practice (GMP) compliance, purity standards (USP/NF, BP), and safety testing.

Industrial and agricultural uses face less stringent regulations but are subject to environmental and safety laws, particularly regarding emissions and waste management.

Investment Fundamentals

R&D Pipeline and Patents

Ammonium chloride itself is a commodity with stable demand; however, proprietary formulations involving ammonium chloride, especially in drug delivery or novel therapeutic applications, could create value. Currently, no specific patents for ammonium chloride exist that would significantly affect generic manufacturing.

Pricing Trends

Average prices in 2022 ranged from $700 to $900 per metric ton, with slight fluctuations based on purity levels and regional factors. Price volatility increases with supply chain disruptions or raw material costs.

Cost Structure

Production costs vary between $200 and $350 per metric ton, with main expenses in raw materials (ammonia, hydrogen chloride), energy, and environmental compliance. Economies of scale influence profitability margins.

Competitive Landscape

Key players include:

  • Hubei New Century Environmental Protection Chemical Co., Ltd.
  • Zhangzhou Advanced Chemicals
  • Tosoh Corporation

Market share remains fragmented, with no single firm dominating globally. Entry barriers are moderate, mainly due to raw material access, environmental regulations, and established relationships.

Investment Risks

  • Supply chain disruptions due to geopolitical tensions or environmental regulations.
  • Price fluctuations driven by raw material costs and demand cycles.
  • Regulatory changes impacting production or export/import policies.
  • Limited innovation in the core compound reduces upside potential unless tied to proprietary formulations.

Opportunities

  • Expansion in regions with growing fertilizer and pharmaceutical industries.
  • Development of pharmaceutical formulations that enhance bioavailability or stability.
  • Integration into biodegradable and environmentally friendly products aligning with regulatory trends.

Financial Metrics

  • EBITDA margins from ammonium chloride manufacturing typically range from 20% to 35%, depending on scale and efficiency.
  • Operating margins are sensitive to raw material costs and logistics expenses.
  • Return on invested capital (ROIC) remains moderate, reflecting commodity-like characteristics.

Partnership and Investment Considerations

Investors should evaluate company exposure to raw material price risks, capacity expansion plans, and regulatory compliance capabilities. M&A activity could consolidate market share or enable vertical integration.

Conclusion

Ammonium chloride presents a stable, low-growth investment scenario rooted in commodity markets. Opportunities exist primarily in regional expansion and formulation innovation within the pharmaceutical sector. Risks center on raw material price volatility, supply chain vulnerabilities, and regulatory developments.


Key Takeaways

  • The global ammonium chloride market was valued at $850 million in 2022, growing at approximately 4.2% CAGR.
  • Production relies on ammonia and hydrogen chloride, with China leading capacity.
  • Demand stems from pharmaceuticals, agriculture, and industry, with low innovation potential.
  • Prices range from $700 to $900 per ton; margins are sensitive to raw material costs.
  • Risks include supply chain disruptions and regulatory changes; opportunities lie in regional growth and formulation development.

Frequently Asked Questions

  1. What is the primary use of ammonium chloride in pharmaceuticals?

It acts as an expectorant in cough remedies and as a urinary alkalizer.

  1. How does raw material cost impact profitability?

Raw materials such as ammonia and hydrogen chloride constitute the majority of production costs, directly affecting margins.

  1. Are there patent opportunities for ammonium chloride formulations?

No patent protections currently provide significant competitive advantage for pure ammonium chloride; innovation focuses on formulations.

  1. What geopolitical risks influence the supply chain?

China's dominance in production, along with environmental and trade policies, can cause supply fluctuations.

  1. Is the market likely to see significant technological innovation?

No major technological breakthroughs are expected in the core compound; focus remains on expanding demand and refining manufacturing efficiency.


References

  1. MarketsandMarkets. "Ammonium Chloride Market by Application, Region - Global Forecast to 2027," 2022.

More… ↓

⤷  Get Started Free

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.