MICRO-K Drug Patent Profile

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

Micro-k is a drug marketed by Nesher Pharms and Kv Pharm and is included in two NDAs.

The generic ingredient in MICRO-K 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

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

Summary for MICRO-K

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	314
Patent Applications:	2,329
DailyMed Link:	MICRO-K at DailyMed

US Patents and Regulatory Information for MICRO-K

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	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Nesher Pharms	MICRO-K 10	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-002	May 14, 1984		DISCN	Yes	No
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nesher Pharms	MICRO-K	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-001	Approved Prior to Jan 1, 1982	4,259,315

International Patents for MICRO-K

See the table below for patents covering MICRO-K 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.
Australia	544965

Supplementary Protection Certificates for MICRO-K

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
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215

MICRO-K Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MICRO-K

Introduction

MICRO-K, a brand of potassium chloride extended-release capsules, has been a part of the pharmaceutical market for several decades. However, understanding its current market dynamics and financial trajectory requires a closer look at several key factors, including competition, pricing, and regulatory environments.

Historical Context and Discontinuation

MICRO-K, once a prominent brand, has been discontinued in the U.S. market. This discontinuation is significant as it marks the end of a brand that was once widely used for treating potassium deficiency[5].

Generic Alternatives

With the discontinuation of MICRO-K, the market has shifted towards generic versions of potassium chloride. These generic alternatives are approved by the FDA and offer similar therapeutic benefits at potentially lower costs. This transition has likely impacted the financial trajectory of the original brand, as generic competition often leads to reduced market share and revenue for branded products[5].

Market Competition

The market for potassium chloride products is characterized by high competition, particularly from generic manufacturers. Since MICRO-K is no longer in production, the competition is now among various generic versions. This competition drives prices down, making the product more affordable for consumers but reducing the profit margins for manufacturers[1].

Pricing Dynamics

Pricing for potassium chloride products, including generic versions of MICRO-K, is influenced by several factors:

• Generic Competition: The presence of multiple generic manufacturers leads to competitive pricing, which generally results in lower prices for consumers.
• Regulatory Environment: FDA regulations and approval processes can affect the pricing strategy of pharmaceutical companies. However, for well-established drugs like potassium chloride, the regulatory environment is relatively stable.
• Market Demand: The demand for potassium chloride remains steady due to its essential use in treating hypokalemia, but the demand does not drive up prices significantly due to the availability of generics[1].

Financial Trajectory

The financial trajectory for MICRO-K, or more accurately its generic equivalents, can be summarized as follows:

• Revenue Decline: With the discontinuation of the branded product, revenue from MICRO-K has ceased. Generic versions continue to generate revenue but at lower profit margins due to intense competition.
• Cost Savings: For consumers and healthcare systems, the shift to generic potassium chloride products has resulted in significant cost savings. This is a common outcome when branded drugs lose patent protection and face generic competition.
• Market Stability: The overall market for potassium chloride remains stable, driven by consistent demand for the treatment of potassium deficiency. However, the financial performance of individual manufacturers can vary based on their market share and pricing strategies[1].

Regulatory Considerations

Regulatory factors play a crucial role in the pharmaceutical industry:

• FDA Approval: Generic versions of MICRO-K must obtain FDA approval, ensuring that these products meet the same safety and efficacy standards as the original branded product.
• Safety and Efficacy: Regulatory bodies continue to monitor the safety and efficacy of potassium chloride products. Any adverse events or changes in clinical practice guidelines can impact the market dynamics and financial performance of these products[5].

Consumer Impact

For consumers, the discontinuation of MICRO-K and the availability of generic alternatives have several implications:

• Affordability: Generic potassium chloride products are generally more affordable, making treatment more accessible to a wider population.
• Availability: Despite the discontinuation of MICRO-K, the availability of potassium chloride products remains high due to the presence of multiple generic manufacturers[5].

Key Takeaways

• Discontinuation of Branded Product: MICRO-K is no longer available in the U.S. market.
• Generic Competition: The market is now dominated by generic versions of potassium chloride.
• Pricing Dynamics: Prices are driven down by generic competition, benefiting consumers but reducing profit margins for manufacturers.
• Financial Trajectory: Revenue from branded MICRO-K has ceased, while generic versions generate revenue at lower profit margins.
• Regulatory Stability: The regulatory environment remains stable, ensuring safety and efficacy standards are met.

FAQs

1. Why was MICRO-K discontinued? MICRO-K was discontinued in the U.S. market, but the exact reasons are not specified. However, it is common for branded products to be discontinued when generic alternatives become widely available and cost-effective.

2. What are the generic alternatives to MICRO-K? Generic potassium chloride extended-release capsules are available from various manufacturers and offer the same therapeutic benefits as MICRO-K.

3. How does generic competition affect pricing? Generic competition typically drives prices down, making the product more affordable for consumers but reducing profit margins for manufacturers.

4. What regulatory considerations affect potassium chloride products? FDA approval and ongoing monitoring of safety and efficacy are crucial regulatory considerations for potassium chloride products.

5. How does the discontinuation of MICRO-K impact consumers? Consumers benefit from the availability of more affordable generic potassium chloride products, ensuring continued access to treatment for potassium deficiency.