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Last Updated: December 22, 2024

POTASSIUM Drug Patent Profile


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Which patents cover Potassium, and when can generic versions of Potassium launch?

Potassium is a drug marketed by Exela Pharma, Hospira, Hexcel, Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Chartwell Molecular, Endo Operations, Glenmark Pharms Ltd, Granules, Lupin Ltd, Nesher Pharms, Novel Labs Inc, Padagis Us, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Amneal, Belcher, Epic Pharma Llc, Genus, Novitium Pharma, Rubicon, Abraxis Pharm, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Intl Medication, Lilly, Luitpold, Miles, Nexus Pharms, Pharma Serve Ny, Watson Labs, Anda Repository, Apotex, Genus Lifesciences, Pharm Assoc, Sciegen Pharms Inc, Wes Pharma Inc, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Copley Pharm, Guangzhou Novaken, Macleods Pharms Ltd, Mylan, Rising, Schering, Sigmapharm Labs Llc, Twi Pharms, Yichang Humanwell, Icu Medical Inc, Nexus, Ut Sw Medctr, Ani Pharms, Bionpharma, Hibrow Hlthcare, Teva Pharms Usa Inc, Torrent, Mission Pharmacal, Roxane, Am Regent, Cmp Dev Llc, and Somerset Theraps Llc. and is included in one hundred and fifty-three NDAs. There is one patent protecting this drug.

The generic ingredient in POTASSIUM is potassium phosphate, dibasic; potassium phosphate, monobasic. There are two hundred and forty drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the potassium phosphate, dibasic; potassium phosphate, monobasic profile page.

DrugPatentWatch® Generic Entry Outlook for Potassium

Annual sales in 2021 were $9mm indicating the motivation for generic entry (peak sales were $76mm in 2019).

Indicators of Generic Entry

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Summary for POTASSIUM
Drug patent expirations by year for POTASSIUM
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Drug Sales Revenue Trends for POTASSIUM

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US Patents and Regulatory Information for POTASSIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa POTASSIUM CHLORIDE IN PLASTIC CONTAINER potassium chloride INJECTABLE;INJECTION 088901-001 Jan 25, 1985 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Luitpold POTASSIUM CHLORIDE potassium chloride INJECTABLE;INJECTION 080221-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Icu Medical Inc POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018362-006 Mar 28, 1988 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% potassium chloride; sodium chloride INJECTABLE;INJECTION 212347-003 Jun 2, 2021 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharm Assoc POTASSIUM CHLORIDE potassium chloride SOLUTION;ORAL 210766-001 Mar 29, 2019 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER potassium chloride; sodium chloride INJECTABLE;INJECTION 019708-005 Sep 29, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novitium Pharma POTASSIUM CHLORIDE potassium chloride FOR SOLUTION;ORAL 212816-001 Jul 12, 2023 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

POTASSIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Potassium-Based Drugs

Introduction to Potassium-Based Drugs

Potassium, an essential mineral, plays a critical role in various bodily functions, including maintaining heart rhythm, facilitating muscle and nerve function, and regulating fluid balance. Potassium-based drugs are widely used to treat conditions such as hypokalemia (low potassium levels) and to manage electrolyte imbalances. Here, we delve into the market dynamics and financial trajectory of these drugs.

Market Size and Growth Projections

Pharma Grade Potassium Chloride Market

The global pharma grade potassium chloride market is expected to exhibit significant growth. In 2022, the market size was valued at USD 15 million, and it is projected to reach USD 28.30 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.5%[1].

Injectable Potassium Phosphate Market

The injectable potassium phosphate market is another segment showing robust growth. The global sales of injectable potassium phosphate were estimated at USD 520.4 million in 2023 and are anticipated to reach USD 1,148.7 million by 2034, with a CAGR of 8.1% during the forecast period[3].

Driving Factors

Increasing Demand for Pharmaceutical Products

The increasing global demand for pharmaceutical products is a key driver for the growth of potassium-based drugs. As the population ages and chronic diseases become more prevalent, the need for effective treatments, including electrolyte management, increases[1][3].

Stringent Regulations

Stringent regulations imposed by regulatory authorities, such as the FDA, ensure that pharmaceutical products meet high standards of quality and safety. This environment fosters trust and drives the demand for compliant products like pharma grade potassium chloride[1].

Technological Advancements

Advances in drug formulations and delivery systems are enhancing the efficacy and safety of potassium-based drugs. For instance, the development of injectable potassium phosphate with improved delivery technologies is contributing to market growth[3].

Key Players

The market for potassium-based drugs is dominated by several key players:

  • K+S (Germany)
  • ICL (ICL-IP) (Israel)
  • Klinge Chemicals (U.K.)
  • Morton (U.S.)
  • Anmol Chemicals Group (India)[1].

These companies are at the forefront of producing high-quality potassium-based products that meet stringent regulatory standards.

Regional Market Dynamics

North America

The United States is a significant market for potassium-based drugs, particularly injectable potassium phosphate. The region is expected to exhibit a CAGR of 5.3% through 2034, driven by advanced healthcare infrastructure and increasing awareness of electrolyte imbalances[3].

Europe

Germany holds the highest market share in the European injectable potassium phosphate market, with a CAGR of 5.5% between 2024 and 2034. The advanced healthcare infrastructure and high standards of medical practice in Germany are key factors contributing to this growth[3].

Asia-Pacific

Countries like China and India are witnessing rapid growth in the demand for potassium-based drugs. China is projected to have a CAGR of 20.9%, while India is expected to grow at a CAGR of 21.9% through 2034, driven by increasing chronic diseases and improvements in healthcare infrastructure[3].

Competitive Generic Therapy Pathway

The FDA's Competitive Generic Therapy (CGT) designation has been instrumental in expediting the development and review of generic drugs, including potassium chloride oral solutions. This pathway aims to foster generic competition, reduce the time to market, and ensure affordable access to treatments. For example, the FDA approved several strengths of potassium chloride oral solution as the first generic drugs under the CGT designation, marking a significant step in enhancing market competition[2].

Side Effects and Safety Considerations

While potassium-based drugs are essential for treating conditions like hypokalemia, they come with potential side effects. Common side effects of potassium chloride oral solution include nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. It is crucial for healthcare practitioners to monitor patients closely to manage these side effects effectively[2].

Financial Trajectory

Revenue Growth

The financial trajectory of potassium-based drugs is promising, with significant revenue growth projected across various segments. For instance, the pharma grade potassium chloride market is expected to more than double from USD 15 million in 2022 to USD 28.30 million by 2032. Similarly, the injectable potassium phosphate market is anticipated to grow from USD 520.4 million in 2023 to USD 1,148.7 million by 2034[1][3].

Market Segmentation

The market for potassium-based drugs is segmented by type, application, and end-use industry. For example, the potassium derivative market includes segments such as fertilizers, food additives, pharmaceuticals, and industrial applications. This segmentation helps in understanding the diverse applications and growth potential of potassium-based products[5].

Technological Innovations

Technological advancements in drug delivery systems and formulations are driving the growth of the potassium-based drug market. Innovations such as improved injectable formulations and advanced diagnostic technologies for electrolyte imbalances are enhancing the efficacy and safety of these drugs[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of potassium-based drugs. Regulatory bodies like the FDA ensure that these products meet strict quality and safety standards. The approval of generic drugs under pathways like the CGT designation further supports market competition and affordability[2].

Public Awareness and Healthcare Access

Increasing public awareness of the importance of electrolyte balance and the role of potassium in health is driving demand for potassium-based drugs. Additionally, improvements in healthcare infrastructure and government initiatives to enhance access to healthcare services, such as India's Pradhan Mantri Jan Arogya Yojana, are expanding the market reach of these drugs[3].

Key Takeaways

  • The global market for potassium-based drugs, including pharma grade potassium chloride and injectable potassium phosphate, is expected to grow significantly over the next decade.
  • Key drivers include increasing demand for pharmaceutical products, stringent regulations, and technological advancements.
  • Major players such as K+S, ICL, Klinge Chemicals, Morton, and Anmol Chemicals Group dominate the market.
  • Regional markets, particularly in North America, Europe, and Asia-Pacific, are showing robust growth.
  • Regulatory initiatives like the FDA's CGT designation are enhancing market competition and affordability.
  • Public awareness and improvements in healthcare access are also contributing to market growth.

FAQs

What is the projected market size of the global pharma grade potassium chloride market by 2032?

The global pharma grade potassium chloride market is expected to reach USD 28.30 million by 2032[1].

What is the CAGR of the injectable potassium phosphate market from 2024 to 2034?

The injectable potassium phosphate market is projected to grow at a CAGR of 8.1% from 2024 to 2034[3].

Which regions are expected to witness significant growth in the potassium-based drug market?

North America, Europe, and Asia-Pacific, particularly countries like the U.S., Germany, China, and India, are expected to witness significant growth[3].

What are the common side effects of potassium chloride oral solution?

Common side effects include nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea[2].

How does the FDA's Competitive Generic Therapy (CGT) designation impact the market for potassium-based drugs?

The CGT designation expedites the development and review of generic drugs, fostering market competition, reducing the time to market, and ensuring affordable access to treatments[2].

Sources

  1. Business Research Insights, "Pharma Grade Potassium Chloride Market Size, Report 2032"
  2. FDA, "FDA approves first generic drug under new pathway aimed at enhancing market competition"
  3. Future Market Insights, "Injectable Potassium Phosphate Market: Key Industry Leaders"
  4. Maximize Market Research, "Potassium Methoxide Market: Industry Analysis and Forecast (2023 - 2029)"
  5. Market Research Future, "Potassium Derivative Market Size, Share & Analysis Report 2032"

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