Last Updated: June 19, 2026

SODIUM BICARBONATE IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Sodium Bicarbonate In Plastic Container patents expire, and what generic alternatives are available?

Sodium Bicarbonate In Plastic Container is a drug marketed by Abbott and is included in one NDA.

The generic ingredient in SODIUM BICARBONATE IN PLASTIC CONTAINER is sodium bicarbonate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sodium Bicarbonate In Plastic Container

A generic version of SODIUM BICARBONATE IN PLASTIC CONTAINER was approved as sodium bicarbonate by HOSPIRA on March 4th, 2016.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for SODIUM BICARBONATE IN PLASTIC CONTAINER?
  • What are the global sales for SODIUM BICARBONATE IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for SODIUM BICARBONATE IN PLASTIC CONTAINER?
Summary for SODIUM BICARBONATE IN PLASTIC CONTAINER
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for SODIUM BICARBONATE IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott SODIUM BICARBONATE IN PLASTIC CONTAINER sodium bicarbonate SOLUTION;INTRAVENOUS 019443-001 Jun 3, 1986 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbott SODIUM BICARBONATE IN PLASTIC CONTAINER sodium bicarbonate SOLUTION;INTRAVENOUS 019443-002 Jun 3, 1986 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

Investment Scenario and Fundamentals Analysis for Sodium Bicarbonate in Plastic Containers

Last updated: February 20, 2026

What is the current market environment for sodium bicarbonate?

Sodium bicarbonate, also known as baking soda, is used across multiple industries including pharmaceuticals, food additive, and industrial cleaning. Its pharmaceutical application, especially as an antacid, is a stable segment. The global sodium bicarbonate market size was valued at approximately USD 1.25 billion in 2022, with a compound annual growth rate (CAGR) of 4.2% expected through 2030. Increasing demand stems from its essential role in acid neutralization, emergency medicine, and buffered solutions.

How does formulation in plastic containers influence investment fundamentals?

Packaging in plastic containers enhances product stability and delivery convenience. It reduces packaging costs compared to glass, supports portability, and aligns with regulatory safety standards for pharmaceutical products. The shift towards plastic also encourages adoption in outpatient settings and home-care environments. This packaging approach broadens the market access, potentially increasing sales volume and margins.

What are key regulatory factors affecting the product?

The pharmaceutical-grade sodium bicarbonate must comply with monographs in United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other regional pharmacopeias. Packaging safety standards include regulations from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent bodies. Approval pathways for new formulations involve abbreviated or full Drug Master Files (DMF). Regulatory adherence impacts time-to-market and potential market size.

What supply chain considerations impact investment risk?

Supply chain stability relies on quality raw materials, often mined from natural deposits. Key suppliers operate in North America, Asia, and Europe. Political, environmental, or logistical disruptions can affect availability and lead times. Manufacturing facilities in low-cost regions can reduce costs but pose risks related to quality control and regulatory compliance.

How does competitive landscape influence investment?

Global players include companies like E. I. du Pont de Nemours and Co., Sandoz (Novartis), and local generic manufacturers. Market share is fragmented but consolidates around larger producers with established distribution channels. Barriers to entry are moderate due to regulatory requirements but high segment saturation. Innovation is limited; differentiation focuses on packaging, pricing, and supply reliability.

Investment fundamentals summary

Indicator Data / Expectation
Market size (2022) USD 1.25 billion
CAGR (2023-2030) 4.2%
Regulatory requirements Strict, regionalized
Raw material supply reliance Natural mineral deposits
Packaging trend Shift to plastic containers
Main competitors Large multinational firms
Entry barriers Moderate, regulatory-driven

What are the growth drivers and risks?

Drivers:

  • Increasing use in hospital and outpatient settings
  • Rising demand for over-the-counter antacids
  • Growth in emerging markets with expanding healthcare infrastructure
  • Cost advantages of plastic packaging

Risks:

  • Regulatory changes tightening quality standards
  • Raw material price volatility
  • Competition from alternative buffering agents
  • Environmental concerns about plastic waste

How does the product's positioning affect valuation?

The stable demand pattern for pharmaceutical-grade sodium bicarbonate provides residual cash flow stability suitable for low-risk investment. Packaging innovations in plastic containers open incremental growth opportunities for existing manufacturers. However, lack of significant product differentiation limits speculative upside. Valuations should consider market size, competitive moat, regulatory compliance costs, and supply chain stability.

Key Takeaways

  • The global market for pharmaceutical-grade sodium bicarbonate in plastic containers remains steady, with modest growth prospects.
  • Manufacturing advantages for packaged products include cost reduction and convenience, supporting margins.
  • Regulatory compliance remains a critical barrier to entry and ongoing market expansion.
  • Supply chain stability relies on raw mineral assets and regional manufacturing networks.
  • Competition is fragmented but dominated by multinational firms with established distribution channels.
  • Investment risks include regulatory shifts, raw material costs, and environmental pressures on plastic packaging.

FAQs

1. What regulatory bodies govern sodium bicarbonate used pharmaceutical?
The FDA, EMA, and regional pharmacopeias regulate pharmaceutical-grade sodium bicarbonate.

2. Are there patent protections for sodium bicarbonate formulations?
No, sodium bicarbonate is a generic chemical with limited patent protection; focus is on packaging and formulation innovations.

3. How significant is the role of plastic packaging in product differentiation?
While not directly affecting pharmacological efficacy, plastic packaging influences distribution, cost, and consumer convenience.

4. Is raw material supply a risk factor?
Yes, as sodium bicarbonate is mined from natural mineral deposits, supply disruptions can impact costs and production.

5. What market segments are driving growth for this product?
Main growth drivers include hospital use, over-the-counter medications, and emerging economies investing in healthcare infrastructure.

References

[1] Grand View Research. (2023). Sodium Bicarbonate Market Size, Share & Trends Report.
[2] U.S. Pharmacopeia. (2022). USP Monograph for Sodium Bicarbonate.
[3] MarketsandMarkets. (2022). Pharmaceutical Packaging Market by Material, Type, and Region.

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.