IMODIUM A-D Drug Patent Profile

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

Imodium A-d is a drug marketed by J And J Consumer Inc and is included in three NDAs.

The generic ingredient in IMODIUM A-D is loperamide hydrochloride. There are eleven drug master file entries for this compound. One hundred and four suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Imodium A-d

A generic version of IMODIUM A-D was approved as loperamide hydrochloride by MYLAN on September 18^th, 1991.

Summary for IMODIUM A-D

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	25
Patent Applications:	3,419
What excipients (inactive ingredients) are in IMODIUM A-D?	IMODIUM A-D excipients list
DailyMed Link:	IMODIUM A-D at DailyMed

See drug sales revenues for IMODIUM A-D

Recent Clinical Trials for IMODIUM A-D

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

Sponsor	Phase
MedSIR	Phase 2
Gilead Sciences	Phase 2
9 Meters Biopharma, Inc.	Phase 1/Phase 2

See all IMODIUM A-D clinical trials

Pharmacology for IMODIUM A-D

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

US Patents and Regulatory Information for IMODIUM A-D

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 A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988		OTC	Yes	Yes
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	SUSPENSION;ORAL	019487-002	Jul 8, 2004		OTC	Yes	Yes

Expired US Patents for IMODIUM A-D

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988

International Patents for IMODIUM A-D

See the table below for patents covering IMODIUM A-D around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	762133
Switzerland	553182	PROCEDE DE PREPARATION DE 2,2-DIARYL-4-(4'-ARYL-4'-HYDROXYPIPERIDINO)-BUTYRAMIDES OU -VATERAMIDES.
Israel	36949	SUBSTITUTED,2,2-DIARYL-4-PIPERIDINOBUTYRAMIDES AND SALTS THEREOF AND THEIR PREPARATION

Supplementary Protection Certificates for IMODIUM A-D

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 A-D Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Imodium A-D

Overview of Imodium A-D

Imodium A-D, commonly known by its active ingredient loperamide, is a widely used antidiarrheal medication. It is marketed under various brand names, including Imodium, Imodium A-D, and Imodium Multi-Symptom Relief. Loperamide works by slowing intestinal movement, thereby reducing the frequency of diarrhea[2][5].

Global Antidiarrheal Drug Market

Market Size and Growth

The global antidiarrheal drug market, in which Imodium A-D is a significant player, is projected to grow substantially. As of 2024, the global antidiarrheal drug market size is estimated to be USD 102,154.2 million, with a compound annual growth rate (CAGR) of 5.20% from 2024 to 2031[1].

Regional Market Share

• North America: This region holds the largest market share, with a market size of USD 40,861.7 million in 2024 and a CAGR of 3.4% from 2024 to 2031. The United States is the dominant market within North America, with a market size of USD 32,239.9 million in 2024 and a CAGR of 3.2%[1].
• Europe: Europe accounts for more than 30% of the global revenue, with a market size of USD 30,646.26 million in 2024 and a CAGR of 3.7% from 2024 to 2031[1].
• Asia Pacific: This region is growing rapidly, with a market size of USD 23,495.5 million in 2024 and a CAGR of 7.2% from 2024 to 2031. Countries like India and Australia are contributing significantly to this growth, with India's market expected to grow at a CAGR of 9% and Australia's at 6.9% during the same period[1].

Market Segments and Drivers

Drug Class

The antidiarrheal drug market is segmented into various drug classes, with motility-modifying drugs, such as loperamide, holding the largest market share. These drugs are effective in slowing intestinal movement, making them a preferred choice for managing acute diarrhea[1].

Application and Type

The market is also segmented by application (adults and children) and type (OTC and prescription drugs). Imodium A-D is widely available as an OTC medication, which contributes to its high market share and accessibility[4].

Growth Drivers

• Increasing Prevalence of Diarrhea: The rise in diarrhea cases, particularly in developing countries due to improper eating habits and lack of clean water, is a significant driver for the market[3].
• Government Initiatives: Government efforts to improve healthcare facilities and increase awareness about antidiarrheal drugs are also driving the market growth[3].
• Chronic Conditions: The increasing diagnoses of chronic conditions like irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) are boosting the demand for advanced prescription medications, including those in the mucosal protectants category[1].

Financial Trajectory

Revenue and Growth Rate

The financial trajectory of Imodium A-D is closely tied to the overall antidiarrheal drug market. Given its dominant position, Imodium A-D benefits from the market's growth. Here are some key financial metrics:

• Global Market Size: The global antidiarrheal drug market is expected to grow from USD 102,154.2 million in 2024 to a higher figure by 2031, driven by a CAGR of 5.20%[1].
• Regional Growth: In North America, where Imodium A-D has a significant presence, the market is expected to grow at a CAGR of 3.4% from 2024 to 2031[1].

Market Share

Imodium A-D, being a leading brand in the motility-modifying drugs segment, holds a substantial market share. The motility-modifying drugs segment is the largest in the antidiarrheal drug market, driven by the efficacy of drugs like loperamide in managing acute diarrhea[1].

Challenges and Restraints

Side Effects and Misuse

One of the significant challenges facing Imodium A-D is the potential for cardiac issues associated with its misuse. When taken in doses beyond the recommended amounts, loperamide can lead to serious cardiac problems, including abnormal heart rhythms and increased risk of death. This has led to FDA safety alerts and warnings on the drug's packaging[2].

Regulatory Actions

The FDA has issued several warnings and safety alerts regarding the misuse of loperamide. In 2016, the FDA warned about the dangers of overdosing on loperamide, and in 2017, a Heart Alert warning was included in the Drug Facts labels to caution users about the potential for fatal heart problems[2].

Competition and Traditional Remedies

The market also faces competition from traditional and home remedies, which some people prefer over pharmaceutical treatments. This preference can restrain the growth of the antidiarrheal drug market, including the sales of Imodium A-D[3].

Future Outlook

Market Expansion

The antidiarrheal drug market, including Imodium A-D, is expected to expand significantly in the coming years. The growing awareness of antidiarrheal drugs with fewer side effects and the increasing prevalence of diarrhea cases will continue to drive market growth[3].

Product Development

To stay competitive, manufacturers may focus on developing new formulations and combinations, such as Imodium Multi-Symptom Relief, which treats both diarrhea and gas. These innovations can help maintain market share and attract new consumers[5].

Key Takeaways

• Market Growth: The global antidiarrheal drug market is projected to grow at a CAGR of 5.20% from 2024 to 2031.
• Regional Dominance: North America holds the largest market share, with the United States being a key market.
• Drug Class: Motility-modifying drugs, such as loperamide, dominate the market.
• Challenges: Misuse and side effects, particularly cardiac issues, are significant challenges.
• Future Outlook: The market is expected to expand, driven by increasing awareness and prevalence of diarrhea cases.

FAQs

Q: What is the current market size of the global antidiarrheal drug market?

A: The global antidiarrheal drug market size is estimated to be USD 102,154.2 million in 2024[1].

Q: What is the expected CAGR of the global antidiarrheal drug market from 2024 to 2031?

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

Q: Which region holds the largest market share in the antidiarrheal drug market?

A: North America holds the largest market share, with a market size of USD 40,861.7 million in 2024[1].

Q: What are the potential cardiac issues associated with the misuse of Imodium A-D?

A: Misuse of Imodium A-D can lead to serious cardiac problems, including abnormal heart rhythms and increased risk of death[2].

Q: Why is the mucosal protectants category growing rapidly in the antidiarrheal drug market?

A: The mucosal protectants category is growing due to the increasing diagnoses of chronic conditions like irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), which require more targeted, long-term treatments[1].

Sources

1. Cognitive Market Research: Antidiarrheal Drug Market Report 2024 (Global Edition)
2. AutoAccident.com: Imodium and Cardiac Issues
3. Verified Market Research: Loperamide HCI Market Size | Trends | Growth | Scope | Forecast
4. The Business Research Company: Antidiarrhoeals Market Size, Trends, Growth And Global Forecast To ...
5. Wikipedia: Loperamide