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Last Updated: January 2, 2025

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE Drug Patent Profile


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When do Loperamide Hydrochloride And Simethicone patents expire, and what generic alternatives are available?

Loperamide Hydrochloride And Simethicone is a drug marketed by 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 eight NDAs.

The generic ingredient in LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Loperamide Hydrochloride And Simethicone

A generic version of LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE was approved as loperamide hydrochloride; simethicone by PERRIGO R AND D on September 5th, 2018.

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Summary for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Drug patent expirations by year for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Recent Clinical Trials for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

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

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

See all LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE clinical trials

Pharmacology for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Physiological EffectSkin Barrier Activity

US Patents and Regulatory Information for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET, CHEWABLE;ORAL 076029-001 Aug 30, 2002 DISCN 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
Granules LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 215981-001 Aug 29, 2022 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 077500-001 Sep 6, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Loperamide Hydrochloride and Simethicone

Introduction to Loperamide Hydrochloride and Simethicone

Loperamide hydrochloride and simethicone are combined in a medication that treats acute nonspecific diarrhea and associated gas-related abdominal discomfort. This combination, often marketed under brand names like Imodium Multi-Symptom Relief, has been proven to provide faster and more complete relief compared to its individual components or placebo[1][4][5].

Market Overview

The global market for loperamide hydrochloride is growing at a moderate pace, driven by several key factors.

Drivers of Market Growth

  • Increasing Awareness and Demand: There is a growing awareness of antidiarrheal drugs with fewer side effects, which is driving the demand for loperamide hydrochloride. This increased awareness, coupled with a rise in the prevalence of diarrhea cases, is a significant driver of market growth[3].
  • Government Initiatives: Government initiatives aimed at improving healthcare facilities, particularly in developing countries, are also boosting the market. These initiatives often include better access to medications like loperamide hydrochloride and simethicone[3].
  • Population Needs: In developing countries, a large population faces issues like diarrhea due to improper eating habits, creating a substantial market potential[3].

Restraints on Market Growth

  • Side Effects: Despite its efficacy, loperamide hydrochloride can have side effects, which can deter some users. Taking more than the recommended dose can lead to serious heart problems, including abnormal heartbeats and potentially death[2].
  • Traditional Remedies: Many people still prefer traditional and home remedies over pharmaceuticals, which can restrain the growth of the loperamide hydrochloride market[3].

Financial Trajectory

Market Size and Forecast

The global loperamide hydrochloride market is expected to grow significantly over the forecast period from 2020 to 2027. The market has been growing at a moderate pace in recent years and is anticipated to continue this trend due to the increasing demand for effective antidiarrheal medications[3].

Revenue Outlook

The revenue generated by the loperamide hydrochloride market is expected to increase substantially. This growth is driven by the expanding use of the drug in various regions, particularly in North America, Europe, and the Asia Pacific. The market outlook section of the global loperamide hydrochloride market report highlights the fundamental dynamics, including drivers, restraints, opportunities, and challenges that impact the market's revenue[3].

Competitive Landscape

The competitive landscape of the loperamide hydrochloride market is diverse and includes several major players.

Key Players

  • Tapi Teva: Known for its strong presence in the pharmaceutical market, Tapi Teva is one of the leading manufacturers of loperamide hydrochloride.
  • Lianyungang Yaran Fine Chemicals: This company is another significant player, contributing to the global supply of loperamide hydrochloride.
  • Venturepharm Group: Venturepharm Group, along with other companies like Xinya Pharma, Neuraxpharm, Viruj Pharma, Synergy Pharmaceutical, and Ausun Pharmaceutical, are key competitors in the market[3].

Market Ranking and Strategies

The market ranking of these companies is based on their financial performance, product benchmarking, and SWOT analysis. Key development strategies include expanding product lines, entering new markets, and enhancing distribution networks to increase market share[3].

Geographical Distribution

The loperamide hydrochloride market is segmented geographically into several regions:

North America

  • The U.S., Canada, and Mexico are significant markets in North America, driven by high healthcare standards and consumer awareness[3].

Europe

  • Countries like Germany, the U.K., and France are major contributors to the European market, with a strong focus on pharmaceutical research and development[3].

Asia Pacific

  • This region, including countries like China, Japan, and India, offers substantial growth potential due to a large population and increasing healthcare needs[3].

Rest of the World

  • Other regions, including Latin America, Africa, and the Middle East, also present opportunities for market expansion[3].

Clinical Efficacy and Safety

The combination of loperamide hydrochloride and simethicone has been clinically proven to be highly effective.

Efficacy

  • Studies have shown that patients who received the loperamide-simethicone combination had significantly shorter times to last unformed stool and faster relief of gas-related abdominal discomfort compared to those who received loperamide, simethicone, or placebo alone[1][4].

Safety

  • The combination is well tolerated, with no significant differences in adverse events found among treatment groups. However, it is crucial to follow dosage instructions to avoid serious side effects[1][4].

Consumer and Market Trends

Consumer Preferences

  • Consumers are increasingly looking for medications that offer comprehensive relief from multiple symptoms. The loperamide-simethicone combination meets this need by treating both diarrhea and gas-related discomfort[5].

Market Trends

  • The trend towards over-the-counter (OTC) medications is also favorable for loperamide hydrochloride, as it has been available as an OTC medication in the U.S. since 1988[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of loperamide hydrochloride.

Approval and Availability

  • Loperamide hydrochloride was originally approved for prescription use in Europe in 1973 and in the U.S. in 1977. Its availability as an OTC medication has expanded its market reach[1].

Safety Warnings

  • Regulatory bodies emphasize the importance of adhering to dosage instructions to avoid serious side effects, such as heart problems[2].

Key Takeaways

  • The loperamide hydrochloride and simethicone combination is highly effective in treating acute nonspecific diarrhea and associated gas-related abdominal discomfort.
  • The global market for loperamide hydrochloride is growing, driven by increasing awareness, government initiatives, and population needs.
  • Major players in the market include Tapi Teva, Lianyungang Yaran Fine Chemicals, and others.
  • The market is segmented geographically, with North America, Europe, and the Asia Pacific being significant regions.
  • The combination is well tolerated but requires adherence to dosage instructions to avoid adverse effects.

FAQs

Q: What are the primary uses of loperamide hydrochloride and simethicone? A: Loperamide hydrochloride and simethicone are used to treat acute nonspecific diarrhea and associated gas-related abdominal discomfort, including symptoms like gas pain, cramps, gas pressure, and bloating[1][5].

Q: What are the potential side effects of loperamide hydrochloride? A: Taking more than the recommended dose of loperamide hydrochloride can cause serious heart problems, including abnormal heartbeats and potentially death. It is also important to note that it should not be given to children under 2 years of age[2].

Q: How does the loperamide-simethicone combination compare to its individual components? A: The loperamide-simethicone combination provides faster and more complete relief of acute nonspecific diarrhea and associated gas-related abdominal discomfort compared to loperamide, simethicone, or placebo alone[1][4].

Q: What are the key drivers of the loperamide hydrochloride market? A: The market is driven by increasing awareness of antidiarrheal drugs, government initiatives for healthcare improvement, and a rise in the prevalence of diarrhea cases[3].

Q: Which regions are significant for the loperamide hydrochloride market? A: North America, Europe, and the Asia Pacific are significant regions for the loperamide hydrochloride market, with substantial growth potential in developing countries[3].

Sources

  1. Arch Fam Med: Loperamide-Simethicone vs Loperamide Alone for Acute Nonspecific Diarrhea and Gas-Related Abdominal Discomfort.
  2. Drugs.com: Loperamide and Simethicone Information.
  3. Verified Market Research: Loperamide HCI Market Size | Trends | Growth | Scope | Forecast.
  4. PubMed: Loperamide-simethicone vs loperamide alone for acute nonspecific diarrhea and gas-related abdominal discomfort.
  5. Cleveland Clinic: Loperamide; Simethicone oral tablets.

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