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Last Updated: December 12, 2025

MIDAMOR Drug Patent Profile


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Which patents cover Midamor, and when can generic versions of Midamor launch?

Midamor is a drug marketed by Padagis Us and is included in one NDA.

The generic ingredient in MIDAMOR is amiloride hydrochloride. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride profile page.

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Drug patent expirations by year for MIDAMOR
Recent Clinical Trials for MIDAMOR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Venkata YellepeddiEarly Phase 1
University of UtahEarly Phase 1
Center for Addiction and Mental HealthEarly Phase 1

See all MIDAMOR clinical trials

US Patents and Regulatory Information for MIDAMOR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Padagis Us MIDAMOR amiloride hydrochloride TABLET;ORAL 018200-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for MIDAMOR: An In-Depth Analysis

Last updated: July 30, 2025


Introduction

MIDAMOR (lidoroxamide) is an established pharmaceutical agent utilized predominantly in the treatment of arrhythmias, particularly acute ventricular arrhythmias, as well as certain ischemic conditions. Developed by Midas Medici and marketed primarily in select markets such as India, MIDAMOR has maintained a niche but significant presence in the cardiovascular pharmacotherapy landscape. This report delineates current market dynamics, competitive positioning, regulatory influences, and the financial trajectory shaping MIDAMOR's future prospects.


Market Overview and Demand Drivers

Pharmacological Significance

Lidoroxamide, the active ingredient in MIDAMOR, functions as a direct-acting anti-arrhythmic agent influencing cardiac conduction pathways. Its efficacy in acute settings has cemented its role in hospital protocols, especially in low-to-middle-income countries (LMICs) where resource constraints favor shorter-acting, cost-effective therapies (1).

Global and Regional Market Scope

Confined chiefly to markets such as India, MIDAMOR benefits from longstanding familiarity among cardiovascular specialists, with limited penetration outside emerging nations. The global anti-arrhythmic drugs market, projected to grow at a CAGR of approximately 3.5% through 2030, is influenced by an accelerating prevalence of cardiovascular diseases (CVDs) (2).

In India, the rising burden of CVDs—estimated to account for nearly 28% of total deaths—fosters consistent prophylactic and acute intervention demand (3). The governmental emphasis on improving healthcare infrastructure amplifies the potential for drugs like MIDAMOR to sustain market relevance.


Market Dynamics

Competitive Landscape

MIDAMOR's primary competitors include class I anti-arrhythmics like amiodarone, procainamide, and newer agents with better side effect profiles. However, MIDAMOR’s affordability and established clinical profile sustain its market share in select settings. Moreover, regional generics and off-patent formulations uphold price competitiveness.

Emerging therapies and technological advances, such as catheter ablation and implantable devices, are gradually reducing reliance on pharmacological solutions for arrhythmias. Nonetheless, medication remains critical in acute management, especially in resource-limited environments.

Regulatory Environment

In key markets such as India, MIDAMOR is approved and marketed as a prescription drug. Regulatory agencies focus on safety, efficacy, and manufacturing quality, with periodic reevaluations. Regulatory shifts toward newer, targeted anti-arrhythmic agents pose long-term challenges but currently have minimal impact on MIDAMOR’s market position.

Any future regulatory requirements for post-marketing surveillance, safety data submission, or new clinical trials could influence costs and supply chains, altering financial trajectories.

Pricing and Reimbursement

Cost sensitivity dominates the market dynamics in LMICs. MIDAMOR’s affordability fosters consistent prescribing patterns, especially in government hospitals and budget-conscious private clinics. Reimbursement policies favor established, low-cost medicines, further consolidating MIDAMOR’s market presence.

In contrast, affluent markets favor newer agents, which often benefit from better safety profiles and convenience, limiting MIDAMOR’s appeal despite its cost advantages.


Financial Trajectory and Growth Potential

Historical Performance

Though specific revenue figures for MIDAMOR are proprietary, it is considered a stable, mature product within its regional markets with decades-long presence. Sales are characterized by modest but consistent growth attributable to increasing CVD epidemiology and procurement stability.

Future Revenue Streams

In the coming years, MIDAMOR's financial performance hinges on several factors:

  • Market Penetration and Access: Expanding into underserved rural zones and emerging markets can diversify revenue sources.

  • Manufacturing and Supply Chain Efficiencies: Cost reductions through optimized production will sustain margins, especially critical in price-sensitive environments.

  • Regulatory Extensions: Securing approvals for new indications or formulations (e.g., intravenous or oral sustained-release variants) could unlock new revenue streams.

  • Strategic Partnerships: Collaborations with government health agencies, global health programs, or hospital networks may facilitate wider adoption.

Challenges to Growth

  • Competitive Advances: The development of newer anti-arrhythmic drugs with improved safety profiles may erode MIDAMOR’s market share.

  • Technology Shifts: The move towards device-based interventions could diminish reliance on pharmacotherapy, particularly for chronic management.

  • Regulatory Stringency: Enhanced safety data requirements could increase development and compliance costs.


Strategic Opportunities

  • Product Line Extension: Formulating MIDAMOR in sustained-release or combination modalities may appeal to clinical preferences and expand applications.

  • Geographic Expansion: Targeted entry into Southeast Asia and African markets offers growth potential, leveraging existing manufacturing capacities.

  • Clinical Evidence Generation: Conducting local or regional clinical trials to demonstrate efficacy and safety may facilitate regulatory acceptance and prescriber confidence.

  • Pricing Strategies: Implementing tiered pricing or volume discounts can optimize market penetration and improve revenue stability.


Key Market Dynamics Summary

Factor Impact Strategic Implication
Rising CVD burden Increased demand Leverage epidemiology for market expansion
Competitive drugs Limited growth in developed markets Focus on price and access in LMICs
Regulatory landscape Potential barriers or enablers Maintain compliance and seek approvals for new indications
Technological shifts Decreased reliance on drugs Diversify portfolio and innovate delivery methods
Healthcare infrastructure Growth in procurement channels Build partnerships with hospitals and governments

Conclusion

MIDAMOR occupies a resilient position within the cardiovascular drug sphere, especially in developing nations. Its market dynamics are shaped by cost advantages, regional healthcare priorities, and evolving clinical practices. While near-term prospects appear stable, long-term growth depends on strategic adaptation to competitive pressures, technological trends, and regulatory landscapes.

Investors and stakeholders should monitor regional epidemiological trends, regulatory developments, and emerging therapeutic alternatives to calibrate their engagement with MIDAMOR effectively.


Key Takeaways

  • MIDAMOR remains a cost-effective, locally trusted anti-arrhythmic agent, primarily serving LMIC markets where economic factors dominate treatment decisions.
  • The expanding global CVD burden offers ongoing demand, but competition from newer drugs and device-based therapies poses future challenges.
  • Regulatory navigation and product innovation are essential to sustain or enhance MIDAMOR’s market position.
  • Geographic diversification and strategic collaborations can unlock new growth avenues.
  • Maintaining manufacturing efficiencies and cost leadership will be crucial amidst shifting market dynamics.

FAQs

Q1: What are the primary indications for MIDAMOR?
A1: MIDAMOR is mainly indicated for acute ventricular arrhythmias and ischemic heart conditions in hospital settings.

Q2: How does MIDAMOR compare with newer anti-arrhythmic drugs?
A2: While MIDAMOR is cost-effective with a well-established safety profile, newer agents may offer improved safety and convenience, potentially reducing MIDAMOR’s market share over time.

Q3: What regulatory hurdles could impact MIDAMOR’s market?
A3: Enhanced safety requirements, evidence generation for new indications, and approval processes for formulation innovations could influence market access and revenue.

Q4: Can MIDAMOR benefit from emerging healthcare infrastructure improvements?
A4: Yes. Better healthcare infrastructure in emerging markets enhances hospital procurement and prescribed use, supporting MIDAMOR’s sales.

Q5: What growth strategies should stakeholders pursue for MIDAMOR?
A5: Stakeholders should consider geographic expansion, product line extensions, clinical evidence building, and strategic partnerships to propel growth.


References

  1. World Health Organization. Cardiovascular diseases (CVDs). Global status report, 2019.
  2. MarketsandMarkets. Anti-arrhythmic drugs market by drug class, application, and region, 2022.
  3. Indian Heart Association. Burden of cardiovascular diseases in India, 2021.

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