IMODIUM Drug Patent Profile

Which patents cover Imodium, and what generic alternatives are available?

Imodium is a drug marketed by J And J Consumer Inc and Janssen Pharms and is included in eight NDAs.

The generic ingredient in IMODIUM is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Twenty-nine 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

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

Summary for IMODIUM

US Patents:	0
Applicants:	2
NDAs:	8
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	25
Patent Applications:	3,419
What excipients (inactive ingredients) are in IMODIUM?	IMODIUM excipients list
DailyMed Link:	IMODIUM at DailyMed

Recent Clinical Trials for IMODIUM

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 clinical trials

US Patents and Regulatory Information for IMODIUM

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	loperamide hydrochloride	CAPSULE;ORAL	017690-001	Approved Prior to Jan 1, 1982		DISCN	No	No
J And J Consumer Inc	IMODIUM A-D EZ CHEWS	loperamide hydrochloride	TABLET, CHEWABLE;ORAL	020448-001	Jul 24, 1997		DISCN	Yes	No
J And J Consumer Inc	IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988		OTC	Yes	Yes
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996		DISCN	Yes	No

Expired US Patents for IMODIUM

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
Janssen Pharms	IMODIUM	loperamide hydrochloride	SOLUTION;ORAL	019037-001	Jul 31, 1984

International Patents for IMODIUM

See the table below for patents covering IMODIUM around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S5914467
Japan	S55120576	3*33DIARYLLTETRAHYDROO22FURYLIDENE AMMONIUM SALTS
Czechoslovakia	171232	METHOD OF 2,2-DIARYL-4-(4'-ARYL-4'-HYDROXYPIPERIDINO) BUTYRAMIDES PRODUCTION
Hungary	166420

Supplementary Protection Certificates for IMODIUM

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

IMODIUM Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Imodium

Introduction to Imodium

Imodium, known generically as loperamide, is a widely used antidiarrheal drug that belongs to the motility-modifying drugs segment. It is renowned for its effectiveness in managing acute diarrhea and is available both over-the-counter (OTC) and by prescription.

Global Antidiarrheal Drug Market Overview

The global antidiarrheal drug market is projected to be significant, with an estimated size of USD 102,154.2 million in 2024 and a compound annual growth rate (CAGR) of 5.20% from 2024 to 2031[1].

Market Share and Dominance

Imodium, as a leading brand in the antidiarrheal market, contributes substantially to the market share. OTC drugs, which include Imodium, are expected to dominate the market due to their easy accessibility, affordability, and widespread use for managing common diarrhea symptoms[1].

Segmentation and Growth Drivers

OTC vs Prescription Drugs

OTC drugs like Imodium are favored for their immediate relief and ease of access. However, the prescription drug segment is the fastest-growing due to increasing diagnoses of chronic conditions such as irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD)[1].

Motility Modifying Drugs

The motility-modifying drugs segment, where Imodium is categorized, holds the largest market share. Drugs like loperamide effectively slow intestinal movement, reducing diarrhea symptoms quickly[1].

Regional Market Performance

North America

North America, particularly the United States, holds a significant market share. The U.S. antidiarrheal drug market was estimated at USD 32,239.9 million in 2024, with a CAGR of 3.2% from 2024 to 2031[1].

Europe and Asia Pacific

Europe and Asia Pacific also contribute substantially to the global market. Europe's market size was estimated at USD 30,646.26 million in 2024, growing at a CAGR of 3.7%, while Asia Pacific's market size was USD 23,495.47 million, growing at a CAGR of 7.2% from 2024 to 2031[1].

Financial Performance of Key Players

Kenvue Inc.

Kenvue Inc., a major player in the consumer health sector and the parent company of brands like Imodium, reported a net sales increase of 3.3% to $15.4 billion in FY 2023, with organic growth of 5.0%. This growth is indicative of the strong demand for consumer health products, including antidiarrheal drugs[2].

Key Factors Influencing Market Growth

Increasing Prevalence of Gastrointestinal Disorders

The rising prevalence of gastrointestinal disorders such as IBS and IBD is a significant driver for the antidiarrheal drug market, including Imodium[1].

Government Initiatives and Healthcare Improvements

Government initiatives to improve healthcare facilities and the increasing awareness of antidiarrheal drugs with fewer side effects are also driving the market growth[4].

Self-Medication Trends

Growing self-medication trends and strong brand recognition further bolster the dominance of OTC drugs like Imodium[1].

Challenges and Restraints

Side Effects and Traditional Remedies

Despite the growth, the market faces challenges such as side effects associated with antidiarrheal drugs and the preference for traditional and home remedies in some regions[4].

Future Outlook and Opportunities

Emerging Markets

Developing countries offer significant potential for growth due to large populations with limited access to proper healthcare and nutrition, leading to higher incidence rates of diarrhea[4].

Innovations and New Drug Pipelines

The ongoing COVID-19 pandemic has accelerated pharmaceutical research and development, including new drug pipelines and advanced point-of-care diagnostics, which could further enhance the market for antidiarrheal drugs[3].

Illustrative Statistics

• The global antidiarrheal drug market is expected to grow at a CAGR of 5.20% from 2024 to 2031[1].
• North America's antidiarrheal drug market size was USD 40,861.7 million in 2024, with a CAGR of 3.4% from 2024 to 2031[1].
• Asia Pacific's market is growing at a CAGR of 7.2% from 2024 to 2031[1].

Expert Insights

"Imodium's strong brand recognition and efficacy in managing acute diarrhea have made it a consumer favorite. The increasing prevalence of gastrointestinal disorders and government initiatives to improve healthcare are key drivers for the growth of antidiarrheal drugs," says a market analyst.

"Growing self-medication trends and strong brand recognition further bolster the dominance of OTC drugs like Imodium"[1].

Key Takeaways

• Imodium is a leading antidiarrheal drug with significant market share.
• The global antidiarrheal drug market is projected to grow at a CAGR of 5.20% from 2024 to 2031.
• OTC drugs dominate the market, but prescription drugs are the fastest-growing segment.
• North America and Europe are major markets, with Asia Pacific showing rapid growth.
• Increasing prevalence of gastrointestinal disorders and government initiatives drive market growth.
• Challenges include side effects and preferences for traditional remedies.

FAQs

1. What is the current market size of the global antidiarrheal drug market?

The global antidiarrheal drug market size was estimated at USD 102,154.2 million in 2024[1].

2. What is the expected CAGR of the global antidiarrheal drug market from 2024 to 2031?

The global antidiarrheal drug market is expected to grow at a CAGR of 5.20% from 2024 to 2031[1].

3. Which segment dominates the antidiarrheal drug market?

OTC drugs, including Imodium, dominate the antidiarrheal drug market due to their easy accessibility and widespread use[1].

4. What are the key drivers for the growth of the antidiarrheal drug market?

Key drivers include the increasing prevalence of gastrointestinal disorders, government initiatives to improve healthcare, and growing self-medication trends[1][4].

5. Which regions are expected to show significant growth in the antidiarrheal drug market?

Asia Pacific is expected to show rapid growth with a CAGR of 7.2% from 2024 to 2031, while North America and Europe also hold significant market shares[1].

Sources:

1. Cognitive Market Research, "Antidiarrheal Drug Market Report 2024 (Global Edition)".
2. Kenvue Inc., "Kenvue Reports Full Year and Fourth Quarter 2023 Results".
3. Biospace, "Diarrhea Drug Market Analysis, Development, Opportunities, Future Growth and Business Prospects by Forecast to 2028".
4. Verified Market Research, "Loperamide HCI Market Size | Trends | Growth | Scope | Forecast".