IMODIUM MULTI-SYMPTOM RELIEF Drug Patent Profile

When do Imodium Multi-symptom Relief patents expire, and when can generic versions of Imodium Multi-symptom Relief launch?

Imodium Multi-symptom Relief is a drug marketed by J And J Consumer Inc and Kenvue Brands and is included in two NDAs.

The generic ingredient in IMODIUM MULTI-SYMPTOM RELIEF is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Imodium Multi-symptom Relief

A generic version of IMODIUM MULTI-SYMPTOM RELIEF was approved as loperamide hydrochloride; simethicone by PERRIGO R AND D on September 5^th, 2018.

Summary for IMODIUM MULTI-SYMPTOM RELIEF

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	25
DailyMed Link:	IMODIUM MULTI-SYMPTOM RELIEF at DailyMed

Recent Clinical Trials for IMODIUM MULTI-SYMPTOM RELIEF

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

Sponsor	Phase
Gilead Sciences	Phase 2
MedSIR	Phase 2
Naia Pharmaceuticals	Phase 1/Phase 2

See all IMODIUM MULTI-SYMPTOM RELIEF clinical trials

Pharmacology for IMODIUM MULTI-SYMPTOM RELIEF

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists
Physiological Effect	Skin Barrier Activity

Paragraph IV (Patent) Challenges for IMODIUM MULTI-SYMPTOM RELIEF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMODIUM MULTI-SYMPTOM RELIEF	Tablets	loperamide hydrochloride; simethicone	2 mg/125 mg	021140		2004-12-29

US Patents and Regulatory Information for IMODIUM MULTI-SYMPTOM RELIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996		DISCN	Yes	No
Kenvue Brands	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000		OTC	Yes	Yes

Expired US Patents for IMODIUM MULTI-SYMPTOM RELIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996	5,248,505
Kenvue Brands	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000	5,248,505
Kenvue Brands	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000	6,103,260
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996	5,489,436
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996	5,716,641
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996	5,679,376

International Patents for IMODIUM MULTI-SYMPTOM RELIEF

See the table below for patents covering IMODIUM MULTI-SYMPTOM RELIEF around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	95752	PROCESSO PARA A PREPARACAO DE COMPOSICOES FARMACEUTICAS PARA O TRATAMENTO DE DISTURBIOS GASTROINTESTINAIS CONTENDO SIMETICOLONA
Portugal	891776
Germany	69315257
Japan	H1192387	SIMETHICONE/CALCIUM PHOSPHATE ANHYDRIDE COMPOSITION
Spain	2216244
India	171919	A METHOD OF OBTAINING PHARMACEUTICAL COMPOSITIONS FOR TREATING GASTROINTESTINAL DISTRESS

Supplementary Protection Certificates for IMODIUM MULTI-SYMPTOM RELIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0428296	SPC/GB98/013	United Kingdom		PRODUCT NAME: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE; REGISTERED: UK 00242/0314 19970923
0428296	99C0029	Belgium		PRODUCT NAME: LOPERAMIDUM HYDROCHOLORIDUM SEMITHICONUM; NATL. REGISTRATION NO/DATE: 2 IS 145 F3 19990201; FIRST REGISTRATION: GB PL 00242/0314 19970923

IMODIUM MULTI-SYMPTOM RELIEF Market Analysis and Financial Projection

Last updated: February 4, 2026

Market Dynamics for Imodium Multi-Symptom Relief

Imodium Multi-Symptom Relief, marketed primarily as an over-the-counter drug, addresses diarrhea and associated gastrointestinal symptoms. The product’s market dynamics depend on multiple factors: consumer demand, competition, regulatory environment, and geographic expansion.

Demand Drivers

1. Global Gastrointestinal Disorders: Incidence of acute and chronic diarrhea varies by region, influencing demand. The World Gastroenterology Organization reports an increasing burden of gastrointestinal infections, especially in developing countries, spurring demand for effective symptomatic relief [1].

2. Consumer Preference for OTC Medications: The shift toward self-medication enhances market size. Imodium’s OTC status in many markets facilitates accessibility and sales volume.

3. Aging Populations: Increased prevalence of gastrointestinal issues among the elderly supports steady demand. Countries with aging demographics, such as Japan and European nations, present stable markets.

4. Travel and Lifestyle Trends: Increased travel correlates with higher diarrhea incidence, especially traveler's diarrhea. Lifestyle changes, including diet and stress, also impact gastrointestinal health.

Competition Landscape

Imodium faces direct competition from generic loperamide formulations and alternative OTC products for diarrhea relief. Major competitors include:

• Generics: Numerous manufacturers produce loperamide-based products, leading to pricing pressures.
• Alternative OTC Drugs: Products with activated charcoal or probiotics target mild gastrointestinal discomfort but with varying efficacy.

Brand loyalty for Imodium can be eroding owing to price competition. Nonetheless, its established brand recognition and regulatory approvals sustain market presence.

Regulatory and Distribution Considerations

• Regulatory Environment: Mostly allows OTC sales globally but with regional differences. Restrictions or changes, such as packaging or labeling requirements, influence the sales trajectory.
• Distribution Channels: Pharmacies, supermarkets, online platforms expand availability. E-commerce growth particularly in North America and Europe increases product reach.

Financial Trajectory for Imodium Multi-Symptom Relief

The revenue and profitability outlook for Imodium derive from sales volume, pricing strategies, manufacturing costs, and marketing expenses.

Historical Financial Performance

• Johnson & Johnson, the primary marketer of Imodium in some markets, reported global OTC gastrointestinal products generating hundreds of millions of dollars annually. Accurate segmentation data specific to Imodium are limited but pivotal for detailed analysis.
• Imodium's sales growth is historically stable, with fluctuations driven by competitive pressures and regional market saturation.

Sales Projections

• The global OTC gastrointestinal market is expected to grow at a compound annual growth rate (CAGR) of 4-6% through 2030 [2]. Imodium’s market share is projected to benefit from this growth.
• In North America, the market is projected to grow at 3-5% CAGR, driven predominantly by aging populations and increased travel.

Price Dynamics

• Price erosion due to generic competition exerts downward pressure on per-unit revenue.
• Premium formulations or combination products could command higher prices, but largely, Imodium’s pricing remains within competitive ranges.
• Price elasticity varies regionally; in price-sensitive markets like India or Southeast Asia, increased competition suppresses margins.

Cost Structure and Profitability

• Manufacturing costs have declined with technological advances and scale economies.
• Marketing expenses remain substantial, especially for maintaining brand awareness in mature markets.
• Margins depend on regional patent protections, regulatory hurdles, and competitive intensity. Patent expirations or challenges could influence future profitability.

Future Financial Considerations

• The entry of new formulations, such as non-loperamide-based diarrhea treatments, may impact sales.
• Regulatory changes affecting OTC classifications could influence pricing, marketing, and distribution strategies.
• Mergers, acquisitions, or licensing agreements could reshape facility investments and revenue streams.

Summary of Key Points

• Imodium Multi-Symptom Relief's demand hinges on gastrointestinal disorder prevalence, OTC accessibility, and demographic trends.
• Competitive pressures are significant with generics, but brand recognition maintains sales.
• Global growth in the OTC gastrointestinal market supports revenue expansion, with regional differences.
• Price competition and patent issues influence margins, while manufacturing costs trend downward.
• Future revenue depends on market expansion, regulatory changes, and product innovation.

Key Takeaways

• The global OTC gastrointestinal drug market is growing moderately, with Imodium holding a leading position.
• Competition from generics constrains pricing, but brand loyalty sustains sales.
• Aging populations and travel-related diarrhea drive steady demand.
• Regulatory environment impacts market access and sales strategies.
• Cost efficiencies and product differentiation will shape long-term profitability.

FAQs

1. What are the primary regional markets for Imodium? North America, Europe, and parts of Asia-Pacific represent the largest markets due to high prevalence and OTC availability.

2. How does generic competition affect Imodium’s profitability? Increased generic options lead to lower prices and reduced margins but do not necessarily diminish overall sales volume due to brand loyalty.

3. Are there upcoming regulatory changes that could impact Imodium? Potential changes include tighter labeling, OTC-to-prescription shifts, or new safety regulations, especially concerning extended use.

4. What innovations could extend Imodium’s market life? Development of combination therapies or formulations targeting specific gastrointestinal conditions could create new revenue streams.

5. How does global demographic change influence future sales? Aging populations support sustained demand; however, emerging markets with rising middle classes also offer growth opportunities.

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Sources

[1] World Gastroenterology Organization. (2021). "Global prevalence of gastrointestinal infections."

[2] IMARC Group. (2022). "Over-the-counter gastrointestinal drug market: Industry trends, share, size, growth, opportunity and forecast 2022-2027."