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Last Updated: March 19, 2026

ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE Drug Patent Profile


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When do Aluminum Hydroxide And Magnesium Trisilicate patents expire, and when can generic versions of Aluminum Hydroxide And Magnesium Trisilicate launch?

Aluminum Hydroxide And Magnesium Trisilicate is a drug marketed by Pennex and is included in one NDA.

The generic ingredient in ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE is aluminum hydroxide; magnesium trisilicate. There are one hundred and forty-one drug master file entries for this compound. Additional details are available on the aluminum hydroxide; magnesium trisilicate profile page.

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Summary for ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pennex ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE aluminum hydroxide; magnesium trisilicate TABLET, CHEWABLE;ORAL 089449-001 Nov 27, 1987 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

ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE Market Analysis and Financial Projection

Last updated: February 12, 2026

What is the investment outlook for Aluminum Hydroxide and Magnesium Trisilicate?

The outlook for drugs like Aluminum Hydroxide and Magnesium Trisilicate hinges on their therapeutic use, market dynamics, patent status, manufacturing costs, and regulatory environment. These compounds are over-the-counter (OTC) medications primarily used for indigestion and heartburn relief. Their well-established safety profile and widespread use suggest constrained growth potential but steady cash flow for pharmaceutical companies with existing formulations.

What are the key market and sales fundamentals?

Market Size and Growth

The global antacids market, where Aluminum Hydroxide and Magnesium Trisilicate fall, was valued at approximately $3.65 billion in 2022. It is projected to grow at a Compounded Annual Growth Rate (CAGR) of about 3% from 2023 to 2030. The growth drivers include rising incidences of GERD, lifestyle-related digestive issues, and aging populations.

Market Players and Competition

Major players include Reckitt Benckiser (Gaviscon), Perrigo, and Teva, which sell OTC formulations containing these compounds. Competition centers on formulations, branding, and distribution reach. Generic formulations dominate the market due to patent expirations on branded products.

Patent and Regulatory Landscape

Most formulations are off-patent, leading to intense price competition. Regulatory standards for OTC drugs are strict in major markets (FDA in the US, EMA in Europe) but well-understood. Renewed approval requirements are minimal, supporting sustained market presence without significant R&D investments.

What is the cost structure and profitability landscape?

Manufacturing Costs

Manufacturing involves sourcing raw materials (aluminum hydroxide, magnesium trisilicate) and ensuring compliance with Good Manufacturing Practices (GMP). Raw material costs are stable but susceptible to exchange rate fluctuations and bulk purchase agreements. Production costs are low per unit, owing to generic manufacturing efficiencies.

Pricing and Margins

Pricing varies by region and branding but remains modest. Gross margins on OTC formulations typically range from 40% to 55%. Volume-driven sales compensate for lower per-unit margins, especially for mature products.

What are the regulatory and supply chain considerations?

Regulatory Risks

Relatively minimal for established OTC drugs. However, potential changes include stricter labeling requirements, new safety data requests, or discontinuation of ingredients due to safety concerns (e.g., aluminum accumulation risks in rare cases).

Supply Chain Stability

Raw material supply chains are global, with key sources in Asia. Disruptions from geopolitical or transportation issues could affect production and costs but have historically been manageable.

What are the growth routes and innovation prospects?

Innovation Potential

Limited, as these are low-complexity formulations. New delivery methods (e.g., sustained-release versions, combination OTC products) could offer incremental value but face high regulatory hurdles and limited patent protection.

Expansion Opportunities

Market penetration in emerging economies presents growth potential, driven by rising disposable incomes, urbanization, and increasing prevalence of indigestion. Licensing agreements or acquiring local brands facilitate market entry.

What is the investment risk profile?

  • Market Maturity: High, with predominantly commoditized products.
  • Price Competition: Intense, pressuring margins.
  • Regulatory: Low for existing formulations but potential for future shifts.
  • Patent Life: Largely expired, limiting exclusivity.
  • Innovation: minimal, restricting future differentiation.
  • Supply Chain: susceptible to external shocks.

Key takeaways

  • The OTC antacids market remains stable, with modest growth driven by demographic trends.
  • Most Aluminum Hydroxide and Magnesium Trisilicate formulations are off-patent, leading to aggressive price competition.
  • Margins are constrained; attractiveness depends on cost efficiency and market share.
  • Limited scope for innovation; the focus is on expanding reach, especially in emerging markets.
  • Risks include commoditization, regulatory shifts, and supply chain disruptions.

FAQs

Q1: Are there patent protections for Aluminum Hydroxide and Magnesium Trisilicate formulations?
Most products are off-patent, leading to widespread generic availability and low barriers for new entrants.

Q2: What are the primary growth drivers in the antacid market?
Increasing prevalence of gastroesophageal reflux disease (GERD), rising awareness, and increasing aging populations in emerging economies contribute.

Q3: How do regulatory changes impact these products?
While generally stable, new safety data requests or labeling standards can affect manufacturing costs or market access but are unlikely to eliminate existing formulations.

Q4: What are the main costs involved in manufacturing these drugs?
Raw material procurement, compliance with GMP, and distribution expenses. Raw material costs are stable but sensitive to global supply chain factors.

Q5: Is there potential for innovation in this market segment?
Limited but exists in form of improved delivery systems, combination products, or formulation tweaks for better efficacy or reduced side effects, although patent protection is limited.


Sources:
[1] MarketsandMarkets. "Antacids Market Size, Share & Trends." 2022.
[2] GlobalData. "OTC Drug Market Analysis," 2023.
[3] FDA Guidance for OTC drugs.
[4] Industry reports and company filings.

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