MICRO-K LS Drug Patent Profile

When do Micro-k Ls patents expire, and what generic alternatives are available?

Micro-k Ls is a drug marketed by Kv Pharm and is included in one NDA.

The generic ingredient in MICRO-K LS is potassium chloride. There are two hundred and forty drug master file entries for this compound. Eighty-six 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 Ls

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

Summary for MICRO-K LS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	314
Patent Applications:	2,377
DailyMed Link:	MICRO-K LS at DailyMed

US Patents and Regulatory Information for MICRO-K LS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kv Pharm	MICRO-K LS	potassium chloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	019561-003	Aug 26, 1988		DISCN	Yes	No

Expired US Patents for MICRO-K LS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kv Pharm	MICRO-K LS	potassium chloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	019561-003	Aug 26, 1988	4,259,315

International Patents for MICRO-K LS

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

Country	Patent Number	Title	Estimated Expiration
Australia	544965
France	2484254
Italy	1212512	PREPARATO FARMACEUTICO A BASE DI POTASSIO A CESSIONE CONTROLLATA
Netherlands	192430
Switzerland	648206	COMPOSITIONS PHARMACEUTIQUES A LIBERATION CONTROLEE DE POTASSIUM.

Supplementary Protection Certificates for MICRO-K LS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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
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

Market Dynamics and Financial Trajectory for Micro-K LS

Introduction

Micro-K LS, a mineral supplement used to prevent or treat low levels of potassium in the blood, operates within a specific segment of the pharmaceutical market. Understanding its market dynamics and financial trajectory involves examining its usage, competition, regulatory environment, and the financial performance of its manufacturers.

Uses and Indications

Micro-K LS is an oral dosage form of microencapsulated potassium chloride, designed to provide a controlled release of potassium chloride. It is used for patients who cannot tolerate immediate-release potassium preparations or have compliance issues with other forms of potassium supplements[1].

Market Need and Demand

The demand for potassium supplements like Micro-K LS is driven by the need to manage hypokalemia, a condition characterized by low potassium levels in the blood. This condition can arise from various factors, including certain medications, excessive sweating, and gastrointestinal disorders. The market need is consistent, particularly among patients with chronic conditions that affect potassium levels.

Competitive Landscape

The market for potassium supplements is competitive, with various formulations available, including immediate-release and controlled-release forms. Micro-K LS competes with other controlled-release potassium chloride products, as well as with alternative potassium salts like potassium bicarbonate, potassium citrate, and potassium gluconate. The competitive advantage of Micro-K LS lies in its microencapsulated formulation, which minimizes the risk of gastrointestinal ulceration and bleeding associated with solid potassium chloride dosage forms[1].

Regulatory Environment

Micro-K LS is subject to stringent regulatory oversight. It is approved by the FDA for specific indications and must comply with safety and efficacy standards. The product's labeling and usage guidelines are carefully monitored to ensure patient safety, particularly given the potential for severe adverse effects such as hyperkalemia, gastrointestinal bleeding, and ulceration[1][4].

Side Effects and Safety Concerns

The safety profile of Micro-K LS includes potential side effects such as gastrointestinal bleeding, ulceration, and perforation. These risks necessitate careful patient selection and monitoring. The product is contraindicated in patients with severe gastrointestinal conditions or those who are dehydrated[1].

Dosage and Administration

The dosage of Micro-K LS is tailored to individual patient needs, typically ranging from 20 mEq to 100 mEq per day. The product must be suspended in water or sprinkled on food before ingestion to avoid gastrointestinal complications. The precise administration instructions are crucial to minimize the risk of adverse effects[1].

Financial Performance of Manufacturers

While the specific financial performance of the manufacturers of Micro-K LS is not detailed in the provided sources, the broader pharmaceutical industry's financial dynamics can offer insights. Companies in this sector often face significant research and development expenses, regulatory hurdles, and market competition. For example, companies like MicroVision and Rapid Micro Biosystems, though not directly related to Micro-K LS, illustrate the financial challenges and opportunities in the pharmaceutical and biotech sectors. These companies often report significant research and development expenses and may experience fluctuations in revenue and net losses due to various market and operational factors[2][5].

Revenue and Market Share

The revenue generated by Micro-K LS would be part of the larger market for electrolyte supplements and treatments for hypokalemia. While exact figures for Micro-K LS are not available, the market size for such supplements can be substantial, driven by the ongoing need for potassium replacement therapies. The market share of Micro-K LS would depend on its competitive positioning, pricing, and the effectiveness of its marketing and distribution strategies.

Market Trends and Future Outlook

The pharmaceutical market is subject to various trends, including advancements in drug delivery technologies, increasing regulatory scrutiny, and shifts in patient preferences. For Micro-K LS, the future outlook would depend on its ability to maintain a strong safety profile, comply with evolving regulatory standards, and adapt to changes in market demand and competition.

Impact of Market Power

The broader pharmaceutical industry is also influenced by market power dynamics, as discussed in studies on the rise of market power and its macroeconomic implications. Increased market power can lead to higher prices and reduced output, affecting consumer welfare and the overall efficiency of the market. However, this is more relevant at an industry level rather than specifically for Micro-K LS, unless it operates in a highly concentrated market segment[3].

Key Takeaways

• Market Need: Micro-K LS addresses the need for potassium supplementation, particularly for patients who cannot tolerate immediate-release forms.
• Competitive Landscape: The product competes with other potassium supplements and formulations.
• Regulatory Environment: Strict FDA oversight ensures safety and efficacy.
• Safety Concerns: Potential for severe gastrointestinal side effects necessitates careful patient selection and monitoring.
• Financial Performance: Part of the broader pharmaceutical industry's financial dynamics, with significant R&D expenses and market competition.
• Future Outlook: Dependent on maintaining a strong safety profile, adapting to regulatory changes, and responding to market trends.

FAQs

What is Micro-K LS used for?

Micro-K LS is used to prevent or treat low levels of potassium in the blood, particularly for patients who cannot tolerate immediate-release potassium preparations.

What are the potential side effects of Micro-K LS?

Potential side effects include gastrointestinal bleeding, ulceration, and perforation. Hyperkalemia is also a severe adverse effect.

How is Micro-K LS administered?

Micro-K LS must be suspended in 2-6 fluid ounces of water and stirred thoroughly before ingestion. It can also be sprinkled on food.

Why is Micro-K LS preferred over other potassium supplements?

Micro-K LS is preferred due to its microencapsulated formulation, which minimizes the risk of gastrointestinal complications associated with solid potassium chloride dosage forms.

What are the regulatory considerations for Micro-K LS?

Micro-K LS is subject to FDA approval and must comply with safety and efficacy standards. Its labeling and usage guidelines are carefully monitored to ensure patient safety.

Sources

1. RxList: Micro-K for Liquid Suspension - RxList
2. MicroVision: MicroVision Announces Fourth Quarter and Full Year 2023 Results
3. NBER: The Rise of Market Power and the Macroeconomic Implications
4. FDA: Micro-K - accessdata.fda.gov
5. Rapid Micro Biosystems: Rapid Micro Biosystems Reports Fourth Quarter and Full Year 2023