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:	250
Patent Applications:	3,647
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

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
Philippines	15605	CONTROLLED RELEASE POTASSIUM DOSAGE FORM
Netherlands	8100468
Netherlands	192430
United Kingdom	2077587	CONTROLLED RELEASE POTASSIUM DOSAGE FORM
Canada	1135624	FORME POSOLOGIQUE DE POTASSIUM A LIBERATION PROGRESSIVE (CONTROLLED RELEASE POTASSIUM DOSAGE FORM)
Israel	61817	PHARMACEUTICAL COMPOSITIONS COMPRISING CONTROLLED RELEASE POTASSIUM SALT FORM
Australia	544965

Supplementary Protection Certificates for MICRO-K 10

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
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
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	2012/008	Ireland		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
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

Market Dynamics and Financial Trajectory for MICRO-K 10

Last updated: July 28, 2025

Introduction

MICRO-K 10 is a pharmaceutical drug characterized by its unique composition and clinical applications, often associated with metabolic regulation and nutritional supplementation. As a niche therapeutic agent, its market trajectory depends on multifaceted factors encompassing regulatory decisions, clinical efficacy, market demand, and competitive landscape. This analysis explores these variables, providing a comprehensive overview of the current market environment and forecasted financial trajectory for MICRO-K 10.

Overview of MICRO-K 10

MICRO-K 10 represents a specialized formulation, often composed of potassium-based compounds designed to address deficiencies or imbalances in electrolyte homeostasis. Its primary therapeutic indications include electrolyte replenishment in specific clinical scenarios such as chronic kidney disease, cardiac arrhythmias, and certain neuromuscular disorders.

The drug’s patent status, targeted patient population, and pathway through regulatory agencies significantly influence its market potential. Given its niche applications, MICRO-K 10's market penetration is tightly coupled with clinical acceptance, prescribing practices, and reimbursement policies.

Market Dynamics

1. Clinical Demand and Epidemiology

The global burden of electrolyte imbalance conditions, especially hypokalemia, sustains consistent demand for potassium supplements. Chronic kidney disease (CKD), which affects over 850 million globally [1], significantly contributes to this need, positioning drugs like MICRO-K 10 as vital therapeutic options.

The increasing prevalence of cardiovascular diseases and neuromuscular disorders further elevates the demand for electrolyte management solutions. The aging population drives this trend, with older adults at higher risk of electrolyte disturbances due to comorbidities and polypharmacy. As such, the epidemiological landscape underpins a steady, if specialized, demand for MICRO-K 10.

2. Regulatory Environment

Regulatory approval processes in major markets—such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and parallel agencies in Asia—shape market entry and expansion strategies. MICRO-K 10's safety profile, manufacturing standards, and clinical efficacy data will influence approval timelines and scope.

Patent exclusivity and potential exclusivity extensions impact market share retention and prevent generic competition in early years. Conversely, lack of patent protection may facilitate market entry of competing formulations (e.g., generic potassium supplements), heightening price competition and eroding profit margins.

3. Competitive Landscape

The potassium supplement market is mature, with numerous over-the-counter and prescription-grade products. Established players include Pfizer, Novartis, and generic manufacturers. MICRO-K 10's differentiation hinges on localized release mechanisms, absorption profiles, or combination formulations enhancing patient compliance or clinical outcomes.

Emerging alternatives, including novel drug delivery systems and combination therapies, pressurize MICRO-K 10's market share. Moreover, direct-to-consumer advertising and clinician education influence prescribing patterns, affecting adoption rates.

4. Pricing and Reimbursement

Pricing strategies depend on manufacturing costs, clinical value proposition, and competitive positioning. Reimbursement policies, particularly in the U.S. under Medicare and Medicaid, dictate accessibility and influence prescriber preference.

In markets with high out-of-pocket costs, patient adherence diminishes, impacting sales volumes. Favorable reimbursement and formulary placements bolster market penetration.

5. Market Penetration and Adoption

Clinician acceptance relies heavily on clinical trial outcomes, safety profiles, and clear positioning within treatment guidelines such as those issued by the American Society of Nephrology or cardiology associations. Education campaigns and patient awareness initiatives support adoption, particularly in early-stage clinical settings.

Financial Trajectory

1. Revenue Projections

Initial revenue streams are driven primarily by prescription volume, influenced by disease prevalence and clinical guidelines. For example, in the CKD segment, the rising prevalence portends increasing demand. Assuming MICRO-K 10 secures regulatory approval and competitive differentiation, revenues could grow at an annual rate of 8-12% over the next five years, aligning with the overall growth of electrolyte supplementation markets forecasted at approximately 6.5% CAGR globally [2].

2. Profit Margins and Cost Structure

Gross margins depend on manufacturing efficiency, with economies of scale facilitating margin expansion post-market entry. R&D expenses are significant upfront but decline over time. Marketing and distribution costs are strategic levers to accelerate penetration in targeted markets.

3. Market Risks and Opportunities

Risks include regulatory delays, entry of new formulations, or market saturation. Conversely, opportunities arise from expanding indications (e.g., specific pediatric or geriatric populations), geographic expansion into emerging markets, and technological innovations enhancing drug delivery.

4. Investment and Strategic Outlook

Investment in clinical research to substantiate broader indications and optimize formulation can unlock additional revenue streams. Strategic partnerships with regional distributors can accelerate market penetration, especially in Asia and Latin America.

Concluding Remarks

The financial trajectory of MICRO-K 10 hinges on the confluence of regulatory approval speed, successful clinical positioning, and effective market segmentation. Its niche focus in electrolyte management provides stable, predictable demand aligned with the growing global burden of associated diseases. Early-stage investments should prioritize clinical efficacy demonstration, market education, and strategic alliances to capitalize on impending growth opportunities.

Key Takeaways

• The global increase in chronic illnesses such as CKD sustains long-term demand for potassium supplementation, underpinning MICRO-K 10’s market prospects.
• Regulatory approval and patent exclusivity are critical determinants for initial market penetration and revenue maximization.
• Competition from existing generic formulations necessitates differentiation through formulation advantages and clinical superiority.
• Growth rates are projected to align with the broader electrolyte market CAGR of approximately 6.5%, with potential for higher gains through geographical expansion and indication broadening.
• Strategic investments in clinical research, regulatory navigation, and marketing are essential for capturing and expanding MICRO-K 10’s market share.

FAQs

1. What are the primary clinical applications of MICRO-K 10?
MICRO-K 10 is used mainly for electrolyte replenishment in conditions such as hypokalemia, particularly among patients with chronic kidney disease, cardiovascular conditions, and neuromuscular disorders.

2. How does the regulatory landscape impact MICRO-K 10’s market entry?
Regulatory approvals determine market accessibility. A favorable, expedited approval process can accelerate revenue generation, while delays or rejection can limit market potential and impact financial forecasts.

3. What competitive advantages does MICRO-K 10 offer over existing potassium supplements?
Potential advantages include improved absorption profiles, reduced adverse effects, ease of dosing, or combination formulations that improve patient compliance and clinical outcomes.

4. What factors could influence the pricing and reimbursement of MICRO-K 10?
Pricing is influenced by manufacturing costs, clinical efficacy, market competition, and payer reimbursement policies. Reimbursement frameworks directly impact patient access and sales volume.

5. What are the key growth strategies for MICRO-K 10?
Strategies include expanding clinical indications, geographic expansion, forming strategic partnerships, optimizing formulation delivery, and investing in clinician and patient education.

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Sources:
[1] Global Burden of Disease Collaborative Network. "Global Prevalence of Chronic Kidney Disease," 2022.
[2] MarketsandMarkets. "Electrolyte & Nutritional Supplements Market," 2023.