MICRO-K 10 Drug Patent Profile

When do Micro-k 10 patents expire, and when can generic versions of Micro-k 10 launch?

Micro-k 10 is a drug marketed by Nesher Pharms and is included in one NDA.

The generic ingredient in MICRO-K 10 is potassium chloride. There are two hundred and forty drug master file entries for this compound. Eighty-seven suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Micro-k 10

A generic version of MICRO-K 10 was approved as potassium chloride by ACTAVIS LABS FL INC on April 10^th, 2002.

Summary for MICRO-K 10

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	314
Patent Applications:	2,063
DailyMed Link:	MICRO-K 10 at DailyMed

US Patents and Regulatory Information for MICRO-K 10

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nesher Pharms	MICRO-K 10	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-002	May 14, 1984		DISCN	Yes	No

Expired US Patents for MICRO-K 10

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nesher Pharms	MICRO-K 10	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-002	May 14, 1984	4,259,315

International Patents for MICRO-K 10

See the table below for patents covering MICRO-K 10 around the world.

Country	Patent Number	Title	Estimated Expiration
Italy	8167071
Italy	1212512	PREPARATO FARMACEUTICO A BASE DI POTASSIO A CESSIONE CONTROLLATA
Canada	1135624	FORME POSOLOGIQUE DE POTASSIUM A LIBERATION PROGRESSIVE (CONTROLLED RELEASE POTASSIUM DOSAGE FORM)
Philippines	15605	CONTROLLED RELEASE POTASSIUM DOSAGE FORM
Netherlands	192430
Switzerland	648206	COMPOSITIONS PHARMACEUTIQUES A LIBERATION CONTROLEE DE POTASSIUM.

Supplementary Protection Certificates for MICRO-K 10

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	SPC/GB08/020	United Kingdom		PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
0253310	SPC/GB95/010	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
1718641	SPC/GB12/028	United Kingdom		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
1441735	08C0026	France		PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102

MICRO-K 10 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MICRO-K 10 (Potassium Chloride)

Introduction

MICRO-K 10, a brand of potassium chloride, is a crucial medication used to treat and prevent low blood potassium levels. Understanding the market dynamics and financial trajectory of this drug is essential for stakeholders, including manufacturers, investors, and healthcare providers.

Global Market Overview

The global potassium chloride market, which includes pharmaceutical-grade potassium chloride like MICRO-K 10, is diverse and expansive. Here are some key points:

Market Size and Growth

As of 2024, the global pharma-grade potassium chloride market is estimated to be worth US$ 15 million and is projected to grow to US$ 22 million by 2032, with a Compound Annual Growth Rate (CAGR) of 6.5% during the review period[3].

Broader Market Context

The broader potassium chloride market, which includes applications in fertilizers, industrial sectors, and other areas, is expected to reach US$ 133.50 billion by 2030, growing at a CAGR of 10.50% from 2024 to 2030[3].

Key Applications and Demand Drivers

Pharmaceutical Applications

Potassium chloride, including MICRO-K 10, is primarily used in the pharmaceutical sector to treat hypokalemia (low blood potassium levels). The demand in this sector is driven by the increasing prevalence of conditions that require potassium supplementation and the growing need for effective treatments.

Other Applications

Apart from pharmaceuticals, potassium chloride is used in agriculture as a fertilizer and in various industrial processes. These applications contribute significantly to the overall market size and growth[3].

Market Constraints and Challenges

Economic Impact of COVID-19

The COVID-19 pandemic had a significant impact on the global potassium chloride market, leading to readjustments in market size and growth projections. However, the market is expected to recover and grow steadily in the post-pandemic period[3].

Price Volatility

Price volatility is a key factor hindering the growth of the global potassium chloride market. This volatility can affect production costs and profitability for manufacturers, making it challenging to maintain stable market conditions[3].

Competition

The market is fairly consolidated but is expected to see fragmentation as emerging players try to capitalize on opportunities. This competition, especially in regions like China, can be fierce and challenging for market participants[3].

Financial Performance and Outlook

Revenue Projections

For the pharmaceutical-grade segment, revenue is projected to reach US$ 22 million by 2032. The broader market is expected to achieve significant revenue milestones, reaching US$ 133.50 billion by 2030[3].

Cost Optimization

Companies involved in the production of potassium chloride, such as K+S, are focusing on cost optimization and efficiency improvements. For example, K+S generated significant savings from synergies in procurement, logistics, production, and sales and marketing, which helps in maintaining profitability[3].

Strategic Initiatives

Key players are engaging in strategic initiatives such as production facility expansions, acquisitions, and joint ventures to enhance their market position. These initiatives help in streamlining operations, reducing costs, and increasing market share[3].

Competitive Landscape

Major Players

Major players in the potassium chloride market include ICL (ICL-IP), K+S, and Morton. These companies have a significant presence in the global market and are involved in various strategic initiatives to maintain their market share and competitiveness[3].

Market Share and Competition

In the pharmaceutical sector, the competition is less intense compared to other segments, but it is still significant. The market share of MICRO-K 10 and similar products is influenced by factors such as efficacy, pricing, and brand reputation.

Impact of Generic and Biosimilar Products

Generic Competition

The entry of generic versions of potassium chloride can impact the market share of branded products like MICRO-K 10. However, the pharmaceutical-grade segment tends to have less generic competition compared to other drug categories, which helps in maintaining some level of market stability[3].

Biosimilars

While biosimilars are more relevant in the context of biological products, the principle of generic competition applies similarly. The presence of generic or biosimilar alternatives can drive down prices and affect the revenue of branded products[1].

Supply Chain and Manufacturing

Production and Distribution

The production and distribution of potassium chloride involve complex supply chains, especially for pharmaceutical-grade products. Ensuring the quality and consistency of the product is crucial, and any disruptions in the supply chain can impact market dynamics[4].

Cold-Chain Requirements

For some pharmaceutical products, including certain formulations of potassium chloride, cold-chain requirements are critical. This adds an additional layer of complexity and cost to the manufacturing and distribution process[4].

Regulatory Environment

Regulatory Oversight

The production and sale of potassium chloride are subject to regulatory oversight by health authorities such as the FDA. Compliance with regulatory standards is essential for maintaining market presence and ensuring product safety[3].

Intellectual Property

Protecting intellectual property rights is crucial for manufacturers of branded products like MICRO-K 10. This involves patent protection and other legal measures to prevent unauthorized use or production of the drug[5].

Key Takeaways

• Market Growth: The global pharma-grade potassium chloride market is expected to grow at a CAGR of 6.5% from 2024 to 2032.
• Revenue Projections: The broader potassium chloride market is projected to reach US$ 133.50 billion by 2030.
• Applications: Key applications include pharmaceuticals, agriculture, and industrial sectors.
• Competition: Major players are focusing on cost optimization and strategic initiatives to enhance market position.
• Regulatory Environment: Compliance with regulatory standards is essential for maintaining market presence.

FAQs

What is the projected growth rate of the global pharma-grade potassium chloride market?

The global pharma-grade potassium chloride market is projected to grow at a CAGR of 6.5% from 2024 to 2032[3].

What are the main applications of potassium chloride?

The main applications include pharmaceuticals, agriculture, and industrial sectors[3].

Who are the major players in the potassium chloride market?

Major players include ICL (ICL-IP), K+S, and Morton[3].

How does price volatility affect the potassium chloride market?

Price volatility can affect production costs and profitability for manufacturers, making it challenging to maintain stable market conditions[3].

What are the key regulatory considerations for potassium chloride production?

Compliance with regulatory standards by health authorities such as the FDA is essential for maintaining market presence and ensuring product safety[3].

Sources

1. Competition in Prescription Drug Markets, 2017-2022 - ASPE Report[1]
2. MicroVision Strengthens Financial Position - MicroVision Press Release[2]
3. Global Market Overview of Potassium Chloride - DrugPatentWatch[3]
4. Developing and Retaining Value with Parenteral Products - IQVIA Report[4]
5. Micron Technology INC Form 10-K - Micron Technology INC[5]