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, Onesource Specialty, Roxane, Rubicon Research, Teva, Zydus Lifesciences, Janssen Pharms, Kenvue Brands, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Pai Holdings, Perrigo, Perrigo R And D, Watson Labs, Wockhardt Bio Ag, 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-six NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for loperamide hydrochloride. Ninety-eight suppliers are listed for this compound.

Summary for LOPERAMIDE HYDROCHLORIDE

US Patents:	0
Tradenames:	6
Applicants:	32
NDAs:	46
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	98
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	84
Patent Applications:	7,467
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
Ohio State University Comprehensive Cancer Center	NA
Jiangnan University	NA
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	NA

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
Bionpharma	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	021855-002	Aug 4, 2005		OTC	Yes	Yes
Duramed Pharms Barr	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	074991-001	Dec 29, 1997		DISCN	No	No
Hetero Labs Ltd V	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	211438-001	Jun 17, 2021		OTC	No	No
Contract Pharmacal	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	073254-001	Jul 30, 1993		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	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 EZ CHEWS	loperamide hydrochloride	TABLET, CHEWABLE;ORAL	020448-001	Jul 24, 1997
Kenvue Brands	IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988

Market Dynamics and Financial Trajectory for Loperamide Hydrochloride

Last updated: July 28, 2025

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Introduction

Loperamide hydrochloride, a synthetic opioid receptor agonist, is primarily used as an over-the-counter (OTC) anti-diarrheal medication. Market data suggest that its demand correlates with global incidences of gastrointestinal (GI) disorders, shifts in healthcare practices, and regulatory policies. As a pivotal component of symptomatic management of diarrhea, particularly associated with traveler’s diarrhea and irritable bowel syndrome, understanding its market landscape reveals critical insights for pharmaceutical stakeholders, investors, and healthcare providers.

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Product Overview and Therapeutic Role

Loperamide hydrochloride operates through activation of peripheral mu-opioid receptors in the gastrointestinal tract, decreasing intestinal motility and secretion. Its widespread availability over the counter has cemented its position in global GI disorder management. Its initial patent expiration in the late 20th century facilitated generic formulations, expanding access and favorably impacting market volume, especially in North America, Europe, and parts of Asia.

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Market Size and Growth Drivers

The global sales of loperamide-based products were valued at approximately USD 600 million in 2022, with projections estimating a compound annual growth rate (CAGR) of around 3-5% over the next five years. Factors influencing this trajectory include:

• Rising Incidence of Gastrointestinal Disorders: An increase in acute and chronic diarrhea cases, driven by infections, antibiotic usage, and lifestyle changes, sustains demand.
• Travel and Tourism Trends: International travel elevates the importance of OTC GI remedies, further catalyzed by global pandemics emphasizing self-treatment.
• Healthcare Access and Pharmacovigilance: Improving healthcare infrastructure in developing economies enhances OTC sales penetration, despite regulatory challenges.
• Regulatory Environment: Stringent regulations on opioids' misuse potential can influence product formulations, marketing, and availability, impacting market size.

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Market Dynamics

Competitive Landscape

The market is predominantly composed of generic manufacturers, with a few brand leaders such as Imodium (by Janssen Pharmaceuticals) maintaining premium positioning. Generic formulations account for over 80% of sales due to cost competitiveness. The entry of bioequivalent variants remains steady, fostering price competition.

Regulatory Influences

Given the opioid-based mechanism of action, regulatory agencies globally have tightened controls around loperamide prescription and misuse. Several cases of misuse leading to cardiac toxicity have resulted in updated safety advisories, prompting manufacturing adaptations, including package labeling and dose limitations. These regulations may temper future sales growth but also stimulate innovation in safer formulations.

Innovation and R&D Trends

There is limited scope for novel chemical entities targeting diarrhea due to the well-established pharmacology. However, innovations focus on formulations enhancing safety profiles, extended-release variants, and combination therapies that mitigate misuse risk. Patent expirations have introduced generics that further stimulate market volume.

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Emerging Market Opportunities

• Asia-Pacific Region: Demographic shifts, increased urbanization, and rising healthcare expenditure make APAC a lucrative zone, with countries like India and China experiencing burgeoning OTC markets.
• Elderly Population: Aging demographics worldwide correlate with increased GI complaints, expanding market scope.
• Pandemic Preparedness: COVID-19 highlighted the importance of self-medication for GI symptoms, which could sustain demand for OTC products, including loperamide.

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Challenges Impacting Financial Trajectory

• Safety Concerns and Regulatory Actions: Incidents of misuse have led to restrictions, impacting sales volume.
• Market Saturation and Price Erosion: The proliferation of generics exerts pricing pressure.
• Competition From Alternative Therapies: Adsorbents, probiotics, and other symptomatic treatments encroach on traditional loperamide markets.

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Financial Outlook and Investment Considerations

For stakeholders, the prospects weigh favorably but require cautious navigation. Stable demand, driven by endemic GI disorders and travel-related needs, underpins the outlook, although potential regulatory constraints introduce volatility. Companies investing in product stewardship, safety profiling, and innovative formulations are better positioned to sustain long-term revenue streams.

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Conclusion

Loperamide hydrochloride remains a critical OTC therapeutic for diarrhea, with a robust global market trajectory influenced by demographic, economic, and regulatory variables. While current growth prospects are positive, ongoing safety concerns and market saturation necessitate vigilance and strategic adaptation from industry players.

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Key Takeaways

• The global loperamide market is projected to grow at a CAGR of 3-5%, driven by increasing GI disorder prevalence and expanding access in emerging markets.
• Generic formulations dominate, with key brand players maintaining market share through pricing and safety initiatives.
• Regulatory agencies' safety advisories due to misuse potential are shaping product development and marketing strategies.
• Emerging markets, especially in APAC, present significant growth opportunities, bolstered by rising healthcare spending and urbanization.
• Investment in safer formulations and differentiated products offers a strategic path amid regulatory and competitive challenges.

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FAQs

1. How has the patent expiration of loperamide affected its market dynamics?
Patent expiration facilitated the proliferation of generic formulations, expanding market access and driving down prices. This increased affordability contributed to extended OTC sales globally but also intensified market competition.

2. What regulatory challenges could impact the future sales of loperamide?
Regulatory agencies have imposed restrictions due to misuse cases, including dosage limits and strong warnings. These measures may limit sales volume and require manufacturers to adapt packaging and formulation strategies.

3. Is there potential for innovation within loperamide formulations?
Yes. Focus areas include developing formulations with improved safety profiles, such as extended-release versions or combination therapies that reduce misuse risk, thereby maintaining market relevance.

4. How has the COVID-19 pandemic influenced the demand for loperamide?
COVID-19 increased self-medication tendencies, emphasizing OTC medications like loperamide. However, disruptions in supply chains and regulatory updates have temporarily affected availability and sales.

5. Which regions are expected to drive the most growth in loperamide markets?
The Asia-Pacific region is poised for significant growth due to demographic shifts, increased healthcare expenditure, and expanding OTC markets, complemented by rising awareness and access in Africa and Latin America.

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Sources:

1. [1] Global Market Insights, "Over-the-Counter (OTC) Gastrointestinal Disorders Market," 2022.
2. [2] IMS Health, "Pharmaceutical Market Reports," 2022.
3. [3] Regulatory agencies' safety advisories and pharmacovigilance data.
4. [4] Industry analyst reports on OTC drug markets and regulatory impacts.