LOPERAMIDE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for loperamide hydrochloride and what is the scope of freedom to operate?

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 four 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:	104
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	76
Patent Applications:	7,433
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

Sponsor	Phase
Uniformed Services University of the Health Sciences	Phase 4
Infectious Diseases Clinical Research Program	Phase 4
Henry M. Jackson Foundation for the Advancement of Military Medicine	Phase 4

See all LOPERAMIDE HYDROCHLORIDE clinical trials

Pharmacology for LOPERAMIDE HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Medical Subject Heading (MeSH) Categories for LOPERAMIDE HYDROCHLORIDE

Antidiarrheals

Anatomical Therapeutic Chemical (ATC) Classes for LOPERAMIDE HYDROCHLORIDE

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

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
Teva	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	073192-001	Apr 30, 1992	AB	RX	No	No
Teva	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	073122-001	Aug 30, 1991		DISCN	No	No
Bionpharma	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	021855-001	Aug 4, 2005		OTC	Yes	No
Duramed Pharms Barr	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	074991-001	Dec 29, 1997		DISCN	No	No

Expired US Patents for LOPERAMIDE HYDROCHLORIDE

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

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