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Last Updated: December 22, 2024

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - Generic Drug Details


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What are the generic drug sources for loperamide hydrochloride; simethicone and what is the scope of patent protection?

Loperamide hydrochloride; simethicone is the generic ingredient in two branded drugs marketed by J And J Consumer Inc, Perrigo, Aurobindo Pharma Ltd, Bionpharma, Granules, Guardian Drug, Hetero Labs Ltd V, Perrigo R And D, and Sun Pharm Inds Ltd, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Thirty suppliers are listed for this compound.

Summary for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Recent Clinical Trials for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

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

SponsorPhase
McNeil ABPhase 1
BiogenPhase 4
Rocky Mountain MS Research Group, LLCPhase 4

See all LOPERAMIDE HYDROCHLORIDE; SIMETHICONE clinical trials

Pharmacology for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Physiological EffectSkin Barrier Activity
Anatomical Therapeutic Chemical (ATC) Classes for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Paragraph IV (Patent) Challenges for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
IMODIUM MULTI-SYMPTOM RELIEF Tablets loperamide hydrochloride; simethicone 2 mg/125 mg 021140 2004-12-29

US Patents and Regulatory Information for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 211059-001 Dec 14, 2020 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bionpharma LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 213484-001 Sep 10, 2021 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET, CHEWABLE;ORAL 020606-001 Jun 26, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Guardian Drug LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 214541-001 May 27, 2021 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo R And D LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 209837-001 Sep 5, 2018 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET;ORAL 021140-001 Nov 30, 2000 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Granules LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 215981-001 Aug 29, 2022 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Loperamide Hydrochloride and Simethicone

Introduction

Loperamide hydrochloride and simethicone are widely used medications for the treatment of acute diarrhea and associated gas-related abdominal discomfort. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Growth Drivers

The global market for loperamide hydrochloride is driven by several key factors:

Increasing Prevalence of Gastrointestinal Disorders

The rising incidence of gastrointestinal disorders, such as diarrhea and irritable bowel syndrome (IBS), is a significant driver. Loperamide HCl, with its anti-diarrheal properties, is a preferred treatment option for these conditions[4].

Growing Awareness of Self-Care and OTC Medications

There is an increasing preference for self-care and over-the-counter (OTC) medications, which has boosted the demand for loperamide HCl products. This trend is particularly pronounced in regions with well-established healthcare infrastructures[1].

Technological Advancements and Product Innovations

The introduction of innovative formulations and delivery systems, such as combination products with simethicone, has enhanced the efficacy and patient convenience of loperamide HCl. These advancements have contributed to the market's steady growth[1].

Market Opportunities

Several opportunities are emerging in the loperamide HCl market:

Expanding Distribution Networks and Online Retail

The expansion of distribution networks and online retail platforms has made loperamide HCl products more accessible to consumers worldwide. This increased accessibility is expected to drive market growth, especially in developing regions[1].

Increasing Demand in Developing Regions

Developing regions with a high burden of diarrhea-related diseases present significant growth opportunities. The increasing awareness about self-medication and the expanding pharmaceutical industry in these regions are key factors[1].

Innovative Formulations and Delivery Systems

The introduction of new formulations and dosing options, such as the combination of loperamide with simethicone, offers faster and more complete relief from diarrhea and associated symptoms. This innovation is likely to attract more consumers and drive market growth[5].

Challenges and Constraints

Despite the growth drivers and opportunities, the market faces several challenges:

Potential for Abuse and Misuse

Loperamide HCl has the potential for abuse and misuse, particularly due to its opioid-like effects. This has led to regulatory restrictions and cautionary measures, which can impact market dynamics[1].

Regulatory Restrictions

Regulatory restrictions on the sale and distribution of loperamide HCl are a significant challenge. These restrictions aim to prevent misuse but can limit market access and growth[1].

Emergence of Alternative Treatments

The emergence of alternative treatment options for diarrhea is another challenge. These alternatives may attract consumers away from traditional loperamide HCl products, affecting market share[1].

Regional Analysis

The global loperamide HCl market is segmented into several regions:

North America and Europe

These regions dominate the market due to the high prevalence of gastrointestinal disorders and well-established healthcare infrastructures. The demand for loperamide HCl products is stable and growing in these areas[1].

Asia Pacific

The Asia Pacific region is expected to witness significant growth due to the rising incidence of diarrhea-related conditions, increasing awareness about self-medication, and the expanding pharmaceutical industry[1].

Latin America and the Middle East and Africa

These regions also present growth opportunities with a growing focus on healthcare and improving access to medication. However, challenges such as regulatory hurdles and limited healthcare infrastructure need to be addressed[1].

Competitive Landscape

The loperamide HCl market is highly competitive, with both multinational pharmaceutical companies and local manufacturers operating in the industry. Key players focus on:

Product Innovation

Continuous research and development to improve the efficacy and safety of loperamide HCl formulations are crucial. The introduction of combination products like loperamide-simethicone has been particularly successful[5].

Strategic Collaborations

Strategic collaborations and partnerships between pharmaceutical companies and distributors help in expanding market reach and gaining a competitive edge[1].

Market Expansion

Expansion into emerging markets is a key strategy for market growth. Companies are investing in these regions to capitalize on the growing demand for loperamide HCl products[1].

Financial Trajectory

The financial trajectory of the loperamide HCl market is positive, driven by steady growth:

Market Size and Growth Rate

The global loperamide HCl market is expected to grow at a significant CAGR during the forecast period, driven by the increasing prevalence of gastrointestinal disorders and the demand for effective treatment options[4].

Revenue Streams

The market generates revenue primarily from the sale of OTC loperamide HCl products, including combination products with simethicone. The expansion of distribution networks and online retail platforms has increased revenue streams[1].

Investment in R&D

Pharmaceutical companies are investing heavily in research and development to improve the efficacy and safety of loperamide HCl formulations. This investment is expected to yield returns through the introduction of innovative products and increased market share[1].

Impact of COVID-19

The COVID-19 pandemic had a limited impact on the loperamide HCl market:

Stable Demand

Despite the pandemic, the demand for loperamide HCl for diarrhea treatment remained stable. However, disruptions in supply chains and restrictions on movement affected the availability of products in certain regions[1].

Increased Awareness of Hygiene Practices

The pandemic led to increased awareness about hygiene practices, which may contribute to the prevention of diarrhea-related illnesses. This could have a long-term positive impact on the market by reducing the incidence of diarrhea[1].

Key Industry Developments

Several key developments are shaping the market:

Introduction of New Formulations

The introduction of new formulations and dosing options, such as the loperamide-simethicone combination, has enhanced the market. These products provide faster and more complete relief from diarrhea and associated symptoms[5].

Strategic Collaborations and Partnerships

Strategic collaborations between pharmaceutical companies and distributors are crucial for market expansion and growth. These partnerships help in improving distribution networks and accessing new markets[1].

Expansion into Emerging Markets

The expansion into emerging markets with a high burden of diarrhea-related conditions is a key strategy for growth. Companies are focusing on these regions to capitalize on the growing demand for loperamide HCl products[1].

Efficacy and Safety of Loperamide-Simethicone Combination

The combination of loperamide and simethicone has been proven to be highly effective:

Clinical Trials

A randomized, placebo-controlled, double-blind trial demonstrated that the loperamide-simethicone combination provides faster and more complete relief from acute nonspecific diarrhea and associated gas-related abdominal discomfort compared to loperamide or simethicone alone[3].

Patient Outcomes

Patients who received the loperamide-simethicone combination had significantly shorter times to last unformed stool and faster relief of gas-related abdominal discomfort. The combination was also well-tolerated with no significant differences in adverse events[3].

Dosage and Administration

The dosage and administration of loperamide-simethicone combination products are critical for effective treatment:

Adult Dosage

For adults, the typical dosage is 2 caplets after the first loose stool, followed by 1 caplet after each subsequent loose stool, but no more than 4 caplets in 24 hours[5].

Pediatric Dosage

For children, the dosage varies by age and weight. For example, children aged 6-8 years should take 1 caplet after the first loose stool, followed by ½ caplet after each subsequent loose stool, but no more than 2 caplets in 24 hours[5].

Key Takeaways

  • The global loperamide HCl market is driven by the increasing prevalence of gastrointestinal disorders and the demand for effective OTC medications.
  • The market faces challenges such as potential misuse, regulatory restrictions, and the emergence of alternative treatments.
  • Innovative formulations, such as the loperamide-simethicone combination, have enhanced the market by providing faster and more complete relief from diarrhea and associated symptoms.
  • Expansion into emerging markets and strategic collaborations are key strategies for growth.
  • The COVID-19 pandemic had a limited impact on the market, but increased awareness of hygiene practices may contribute to long-term positive effects.

FAQs

Q: What are the primary drivers of the global loperamide HCl market?

The primary drivers include the increasing prevalence of gastrointestinal disorders, growing awareness of self-care and OTC medications, and technological advancements in drug delivery systems.

Q: What are the challenges faced by the loperamide HCl market?

The market faces challenges such as the potential for abuse and misuse, regulatory restrictions, and the emergence of alternative treatment options.

Q: How does the loperamide-simethicone combination compare to loperamide alone?

The loperamide-simethicone combination provides faster and more complete relief from acute nonspecific diarrhea and associated gas-related abdominal discomfort compared to loperamide alone[3].

Q: What are the typical dosages for loperamide-simethicone combination products?

For adults, the typical dosage is 2 caplets after the first loose stool, followed by 1 caplet after each subsequent loose stool, but no more than 4 caplets in 24 hours. For children, the dosage varies by age and weight[5].

Q: How has the COVID-19 pandemic impacted the loperamide HCl market?

The pandemic had a limited impact on the market, with stable demand for loperamide HCl products. However, disruptions in supply chains and increased awareness of hygiene practices were notable effects[1].

Sources

  1. Global Loperamide HCl market 2024-2032 | Size, Share, Growth - MarkWide Research
  2. Loperamide / Simethicone Dosage Guide + Max Dose, Adjustments - Drugs.com
  3. Loperamide-simethicone vs loperamide alone - PubMed
  4. Loperamide HCl Market Report | Global Forecast To 2028 - Industry Growth Insights
  5. IMODIUM® Multi-Symptom Relief Anti-Diarrheal Medicine Caplets - IMODIUM

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