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Last Updated: February 8, 2025

Loperamide hydrochloride - Generic Drug Details


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

Loperamide hydrochloride is the generic ingredient in six branded drugs marketed by J And J Consumer Inc, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Roxane, Rubicon, Strides Pharma, Teva, Zydus Lifesciences, Janssen Pharms, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Perrigo, Sciegen Pharms Inc, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, Able, Aurobindo Pharma, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for loperamide hydrochloride. One hundred and one suppliers are listed for this compound.

Summary for loperamide hydrochloride
US Patents:0
Tradenames:6
Applicants:31
NDAs:45
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 101
Raw Ingredient (Bulk) Api Vendors: 117
Clinical Trials: 76
Patent Applications: 7,350
What excipients (inactive ingredients) are in loperamide hydrochloride?loperamide hydrochloride excipients list
DailyMed Link:loperamide hydrochloride at DailyMed
Recent Clinical Trials for loperamide hydrochloride

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

SponsorPhase
Uniformed Services University of the Health SciencesPhase 4
Infectious Diseases Clinical Research ProgramPhase 4
Henry M. Jackson Foundation for the Advancement of Military MedicinePhase 4

See all loperamide hydrochloride clinical trials

Pharmacology for loperamide hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for loperamide hydrochloride

US Patents and Regulatory Information for loperamide hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 213070-001 Aug 11, 2021 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Allied LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 073079-001 Apr 30, 1992 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Aurobindo Pharma Ltd LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 211059-001 Dec 14, 2020 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm Inds Ltd LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 077500-001 Sep 6, 2006 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Rubicon LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 216876-001 Jan 26, 2023 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lnk LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 076497-001 Jun 10, 2003 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
J And J Consumer Inc IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487-001 Mar 1, 1988 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc IMODIUM loperamide hydrochloride CAPSULE;ORAL 017694-001 Approved Prior to Jan 1, 1982 ⤷  Try for Free ⤷  Try for Free
J And J Consumer Inc IMODIUM A-D EZ CHEWS loperamide hydrochloride TABLET, CHEWABLE;ORAL 020448-001 Jul 24, 1997 ⤷  Try for Free ⤷  Try for Free
Janssen Pharms IMODIUM loperamide hydrochloride SOLUTION;ORAL 019037-001 Jul 31, 1984 ⤷  Try for Free ⤷  Try for Free
J And J Consumer Inc IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487-001 Mar 1, 1988 ⤷  Try for Free ⤷  Try for Free
J And J Consumer Inc IMODIUM A-D EZ CHEWS loperamide hydrochloride TABLET, CHEWABLE;ORAL 020448-001 Jul 24, 1997 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for Loperamide Hydrochloride

Market Overview

The loperamide hydrochloride market, driven by the increasing incidence of gastrointestinal disorders, is experiencing steady growth. In 2023, the market size was estimated to be approximately USD 5 billion and is projected to reach about USD 7.8 billion by 2033, growing at a compound annual growth rate (CAGR) of 4.5% during the forecast period from 2024 to 2033[1].

Increasing Prevalence of Gastrointestinal Disorders

One of the primary drivers of the loperamide HCl market is the rising incidence of diarrhea and other gastrointestinal disorders. Factors such as contaminated food and water, travel-related stress, and changes in dietary habits contribute to this trend. As the global population faces more frequent and severe gastrointestinal issues, the demand for effective treatments like loperamide HCl continues to rise[1].

Growing Consumer Preference for Over-the-Counter Treatments

There is a noticeable shift towards self-medication and the use of over-the-counter (OTC) medications. Loperamide HCl, available in various OTC formulations, benefits from this trend as consumers increasingly prefer convenient and accessible treatments for common health issues like diarrhea[1].

Technological Advancements in Drug Delivery Systems

Innovations in drug formulation and delivery systems are enhancing the efficacy and patient compliance of loperamide HCl medications. Advanced formulations, such as combination products like Imodium Multi-Symptom Relief, which includes loperamide and simethicone, are contributing to market growth by offering better symptom management and improved patient outcomes[1][2].

Regulatory Challenges and Market Entry Barriers

Despite the growth potential, the loperamide HCl market faces regulatory challenges. Stringent regulatory requirements and concerns over the misuse of loperamide HCl, particularly its potential for abuse as a substitute for opioids, pose significant barriers to market expansion. The FDA has called on manufacturers to limit package sizes to mitigate these risks, although the effectiveness of such measures remains uncertain[2].

Regional Analysis

North America

North America holds a significant share of the loperamide HCl market, driven by high healthcare expenditures, robust regulatory oversight, and strong consumer awareness. Established pharmaceutical companies and extensive distribution networks in this region contribute to its market dominance[1].

Europe

In Europe, the market is supported by increasing incidences of gastrointestinal disorders and stringent regulatory standards ensuring product safety. Pharmaceutical companies focus on product differentiation and strategic partnerships to strengthen their market presence in diverse European markets[1].

Asia Pacific

The Asia Pacific region emerges as a lucrative market opportunity due to rising healthcare awareness, an expanding middle-class population, and increasing access to OTC medications. However, diverse regulatory landscapes and cultural factors require tailored market entry strategies to capitalize on growth potential in countries such as China, India, and Japan[1].

Financial Trajectory

Market Size and Growth

The loperamide HCl market is expected to grow significantly over the next decade. From a market size of USD 5 billion in 2023, it is projected to reach USD 7.8 billion by 2033, with a CAGR of 4.5% during the forecast period[1].

Revenue Streams

The revenue for loperamide HCl comes from both branded and generic products. Branded products, such as Imodium, continue to be major revenue generators, while generic versions also contribute significantly due to their affordability and widespread availability. In 2016, Imodium was one of the biggest-selling branded OTC medications in Great Britain, with sales of £32.7 million[2].

Cost and Pricing

The cost of loperamide HCl can vary based on factors such as the form of the medication, the pharmacy, and the presence of insurance. Generic versions of loperamide HCl are generally more affordable than branded products, making them accessible to a broader consumer base[5].

Future Outlook

Demographic Shifts

Aging populations and the increasing prevalence of chronic diseases are expected to drive higher demand for gastrointestinal therapies, including loperamide HCl. This demographic shift will continue to influence market growth as older populations require more frequent and effective treatments for gastrointestinal issues[1].

Technological Advancements

Continued innovation in drug delivery systems, personalized medicine approaches, and digital health solutions will enhance patient outcomes and treatment adherence. These advancements are likely to further boost the market for loperamide HCl by offering more effective and convenient treatment options[1].

Regulatory Environment

Stricter regulatory oversight and an emphasis on pharmacovigilance will be crucial in mitigating risks associated with medication misuse and abuse. This regulatory environment will shape the market by ensuring safer and more controlled access to loperamide HCl[1].

Market Expansion Strategies

Pharmaceutical companies are expected to expand into emerging markets, engage in strategic collaborations, and diversify their portfolios to capitalize on growth opportunities in therapeutic areas beyond diarrhea treatment. This strategic expansion will help in sustaining market growth and exploring new revenue streams[1].

Key Takeaways

  • Market Growth: The loperamide HCl market is projected to grow from USD 5 billion in 2023 to USD 7.8 billion by 2033 at a CAGR of 4.5%.
  • Drivers: Increasing prevalence of gastrointestinal disorders, growing consumer preference for OTC treatments, and technological advancements in drug delivery systems.
  • Regional Dynamics: North America, Europe, and the Asia Pacific are key regions, each with unique market characteristics and growth opportunities.
  • Regulatory Challenges: Stringent regulatory requirements and concerns over misuse pose significant barriers.
  • Future Outlook: Demographic shifts, technological advancements, and regulatory environment will continue to shape the market.

FAQs

1. What is the current market size of the loperamide HCl market?

The loperamide HCl market size in 2023 is estimated to be approximately USD 5 billion[1].

2. Which region holds the largest share in the loperamide HCl market?

North America holds the largest share in the loperamide HCl market, driven by strong healthcare infrastructure, high consumer awareness, and extensive pharmaceutical networks[1].

3. What are the key drivers of the loperamide HCl market?

The key drivers include the increasing prevalence of gastrointestinal disorders, growing consumer preference for OTC treatments, and technological advancements in drug delivery systems[1].

4. What is the expected CAGR of the loperamide HCl market from 2024 to 2033?

The loperamide HCl market is expected to grow at a CAGR of 4.5% from 2024 to 2033[1].

5. What are the potential risks associated with loperamide HCl misuse?

Loperamide HCl misuse can lead to cardiotoxicity and other serious health issues, prompting regulatory actions to limit package sizes and mitigate these risks[2].

Sources

  1. Data Horizzon Research: Loperamide HCl Market Size, Growth and Analysis Report - 2033
  2. Wikipedia: Loperamide
  3. The Business Research Company: Antidiarrhoeals Global Market Report
  4. Industry Growth Insights: Loperamide HCl Market Report | Global Forecast To 2028
  5. Medical News Today: Imodium cost: Savings options and more

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