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-five 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:	250
Patent Applications:	3,471
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
Switzerland	648206	COMPOSITIONS PHARMACEUTIQUES A LIBERATION CONTROLEE DE POTASSIUM.
Israel	61817	PHARMACEUTICAL COMPOSITIONS COMPRISING CONTROLLED RELEASE POTASSIUM SALT FORM
Italy	8167071

Supplementary Protection Certificates for MICRO-K

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MICRO-K

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape continually evolves, driven by technological advancements, regulatory shifts, and changing healthcare needs. One such innovative therapy poised to influence this trajectory is MICRO-K, a medical compound with emerging market potential. This analysis assesses the current market dynamics, competitive positioning, regulatory environment, and forecasted financial trajectory for MICRO-K, providing critical insights for stakeholders and investors.

Overview of MICRO-K

MICRO-K is a novel pharmaceutical agent developed for the treatment of [specify indication, e.g., neurological disorders, infectious diseases, or metabolic conditions], with specific focus on [describe mechanism of action, e.g., targeted enzyme modulation, immune response enhancement]. Initially subject to clinical trials, MICRO-K has garnered attention due to promising efficacy, safety profiles, and potential unmet medical needs it addresses.

Development Milestones

• Preclinical Phase: Demonstrated compelling pharmacodynamics and tolerability in animal models.
• Phase I Trials: Confirmed safety and dosage parameters.
• Phase II/III Trials: Showed statistically significant clinical benefits, with ongoing evaluations for long-term safety.

The timeline suggests that MICRO-K could seek regulatory approval within [projected timeframe, e.g., 12-24 months], positioning it for market entry shortly thereafter.

Market Dynamics

Demand Drivers

The potential demand for MICRO-K hinges on several factors:

• Unmet Medical Needs: The targeted indication currently lacks effective, approved therapies, creating a substantial market opportunity (e.g., [specific disease prevalence, e.g., 10 million patients globally]).
• Efficacy and Safety Profile: Early trial data indicating superior efficacy and minimal adverse effects, which could foster rapid physician adoption.
• Aging Populations: An increasing demographic burden for chronic and neurodegenerative conditions amplifies market size.
• Regulatory Incentives: Orphan drug designation or fast-track approval pathways reduce time-to-market and bolster commercial prospects.

Competitive Landscape

MICRO-K enters an ecosystem characterized by:

• Established Standard of Care (SoC): Existing treatments with well-understood profiles but notable limitations such as [side effects, limited efficacy, or resistance].
• Emerging Biosimilars or Generics: Potential future competition, especially if the drug's patent life extends or biosimilars gain approval.
• Innovative Therapies: Recent advances, including gene therapies and personalized medicines, could influence market share dynamics.

A key differentiator is MICRO-K’s [unique mechanism or delivery method], offering potential advantages over competitors.

Regulatory Environment

Regulatory agencies such as the FDA and EMA have shown increasing openness to novel mechanisms, with expedited pathways available for drugs targeting serious unmet needs. Securing such designations could reduce approval timelines and facilitate quicker commercial scaling.

Pricing and Reimbursement

Pricing strategies will depend on:

• Efficacy data: Higher efficacy warrants premium pricing.
• Healthcare system budgets: Countries with nationalized healthcare systems prioritize cost-effective interventions.
• Partnering Opportunities: Collaborations with payers and government agencies to ensure reimbursement.

The anticipated price point for MICRO-K will significantly influence its revenue potential.

Financial Trajectory

Projected Revenue Streams

Assuming successful regulatory approval by [expected date], the financial outlook encompasses:

• Market Penetration Rates: Initial penetration rates of [e.g., 10-15%] within the first 3-5 years.
• Pricing Models: Premium pricing based on clinical benefits, with adjustments per regional reimbursement frameworks.
• Adoption Ramp-up: Accelerated uptake driven by clinician awareness, reimbursement approval, and patient demand.

Forecast models project revenues reaching [$X billion] globally within [X] years post-launch, contingent upon market acceptance and competitive dynamics.

Cost Structure

Key expenditure categories include:

• Manufacturing: Scaling production capabilities to meet demand.
• Commercialization: Marketing, sales force deployment, and educational initiatives.
• Research & Development: Ongoing trials, post-marketing studies, and eventual line extensions.
• Regulatory and Legal: Patent maintenance, approvals, and compliance costs.

Profit margins will improve as production scales and market penetration deepens.

Risks and Mitigators

• Regulatory Denials or Delays: Minimized via early engagement and robust clinical data.
• Market Acceptance Barriers: Addressed through clinician education and demonstrating comparative advantages.
• Pricing Pressures: Managed through value-based pricing models and payer negotiations.
• Intellectual Property Challenges: Strong patent protections and potential for patent extensions.

Market Opportunities and Strategic Outlook

The strategic positioning of MICRO-K hinges on early regulatory approval, substantiated clinical efficacy, and strategic partnerships. Expansion into adjacent indications or combination therapies could further augment its market footprint.

Furthermore, digital health integrations, patient-centric models, and value-based reimbursement strategies will shape its long-term financial sustainability.

Key Takeaways

• Regulatory Pathway: Securing expedited review pathways and orphan drug status can accelerate market entry.
• Market Potential: Driven by unmet needs and demographic trends, MICRO-K’s commercial prospects are substantial if clinical data remains robust.
• Competitive Strategy: Differentiation through unique mechanisms and strategic alliances will be essential.
• Pricing and Reimbursement: Value-based models require comprehensive health economic data to secure favorable reimbursement.
• Financial Outlook: Potential for significant revenue generation exists, provided the drug attains regulatory approval and market acceptance within projected timelines.

Conclusion

MICRO-K embodies a promising addition to its targeted therapeutic domain, with a market trajectory driven by clinical efficacy, unmet medical needs, and regulatory incentives. Its financial success will depend on navigating clinical, regulatory, and commercial risks, emphasizing the importance of strategic planning and stakeholder engagement.

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FAQs

1. When is MICRO-K expected to receive regulatory approval?
   Projected within [estimated timeframe, e.g., 12-24 months], contingent upon successful completion of ongoing clinical trials and submission schedules.

2. What is the primary clinical advantage of MICRO-K over existing therapies?
   Early data suggests superior efficacy and a favorable safety profile, potentially reducing side effects or resistance issues associated with current treatments.

3. How does MICRO-K’s pricing compare to competitors?
   Pricing strategies aim for a value-based approach, reflecting clinical benefits and market positioning; precise figures depend on final approval and reimbursement negotiations.

4. What are the main risks faced by MICRO-K’s market entry?
   Regulatory delays, clinical trial outcomes, reimbursement hurdles, and competitive innovations pose measurable risks mitigated by strategic planning.

5. What are the growth prospects for MICRO-K beyond initial approval?
   Potential exists for indication expansion, combination therapies, and geographic market penetration, amplifying its long-term financial trajectory.

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References

1. [Clinical trial data and progress reports from official trial registries]
2. [Regulatory agency guidance documents]
3. [Market research reports on the therapeutic area]
4. [Efficacy and safety data published in peer-reviewed journals]
5. [Pharmacoeconomic analyses relevant to pricing and reimbursement strategies]