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Last Updated: December 22, 2024

LOPERAMIDE HYDROCHLORIDE Drug Patent Profile


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

Loperamide Hydrochloride is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Roxane, Rubicon, Strides Pharma, Teva, Zydus Lifesciences, 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 thirty-seven NDAs.

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

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Drug patent expirations by year for LOPERAMIDE HYDROCHLORIDE
Recent Clinical Trials for LOPERAMIDE HYDROCHLORIDE

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

SponsorPhase
Infectious Diseases Clinical Research ProgramPhase 4
Henry M. Jackson Foundation for the Advancement of Military MedicinePhase 4
Uniformed Services University of the Health SciencesPhase 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
Aurobindo Pharma Ltd LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 211059-001 Dec 14, 2020 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lnk LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 076497-001 Jun 10, 2003 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
Ohm Labs LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 074091-001 Dec 10, 1992 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 218122-001 Sep 5, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 073243-001 Jan 21, 1992 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Able LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 073528-001 Nov 30, 1993 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

LOPERAMIDE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

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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