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 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 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:	1
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
MedSIR	Phase 2
Gilead Sciences	Phase 2
9 Meters Biopharma, Inc.	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
J And J Consumer Inc	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	5,716,641
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996	5,248,505
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000	5,612,054

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
Ireland	62605	Pharmaceutical compositions for treating gastrointestinal distress
Russian Federation	2216317	COMPOSITION SIMETHICONE/ANHYDROUS CALCIUM PHOSPHATE
European Patent Office	0891776	Composition de granule à base de simethicone et phosphate du calcium anhydre en forme granulé (Granular composition comprising simethicone and granular anhydrous calcium phosphate)

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 Experimental

Market Dynamics and Financial Trajectory for IMODIUM MULTI-SYMPTOM RELIEF

Introduction

IMODIUM MULTI-SYMPTOM RELIEF, a product of the Johnson & Johnson subsidiary McNeil Consumer Healthcare, is a widely used over-the-counter (OTC) anti-diarrheal medication. This article delves into the market dynamics and financial trajectory of this drug, exploring factors such as pricing, competition, consumer demand, and regulatory influences.

Market Overview

The OTC anti-diarrheal market is a significant segment within the broader pharmaceutical industry. IMODIUM, with its multi-symptom relief formulation, holds a prominent position in this market. The drug combines loperamide, an opioid receptor agonist, with simethicone, an anti-gas agent, providing comprehensive relief from diarrhea, gas, bloating, cramps, and pressure[5].

Pricing and Cost Factors

The cost of IMODIUM MULTI-SYMPTOM RELIEF can vary based on several factors:

• Formulation: The medication is available in various forms, including caplets, which can affect the price.
• Pharmacy: Prices can differ significantly depending on the pharmacy where the medication is purchased.
• Generic vs. Brand Name: IMODIUM is available as a generic drug, loperamide, which is generally cheaper than the brand-name version. The generic version contains the same active ingredient and is considered just as safe and effective but costs less due to reduced research and development expenses[1][4].

Generic Competition

The availability of generic versions of loperamide has a substantial impact on the market dynamics of IMODIUM. Generic drugs do not require the extensive testing and research that brand-name drugs do, leading to lower production costs and subsequently lower prices for consumers. This competition can drive down the prices of both generic and brand-name versions, making the medication more accessible to a wider audience[1][4].

Financial Assistance and Insurance

For individuals who find the cost of IMODIUM MULTI-SYMPTOM RELIEF prohibitive, various financial assistance programs are available. Websites like NeedyMeds provide information on drug assistance programs, savings cards, and other services that can help reduce the cost of the medication[1].

Consumer Demand

Consumer demand for anti-diarrheal medications is consistent due to the common nature of gastrointestinal issues. IMODIUM MULTI-SYMPTOM RELIEF benefits from its reputation as a reliable and effective treatment, which helps maintain a strong market presence. The product's unique combination of loperamide and simethicone addresses multiple symptoms, making it a preferred choice for many consumers[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of IMODIUM. Historically, loperamide was once a controlled substance in the United States but was removed from the controlled substances list in 1982. However, recent concerns about its misuse for opioid withdrawal symptoms have led to calls for stricter packaging limits, although these measures are not yet fully implemented[3].

Safety and Usage Guidelines

The safety profile of IMODIUM MULTI-SYMPTOM RELIEF is a critical factor in its market trajectory. The medication comes with specific usage guidelines and warnings, such as the risk of serious heart problems if taken in excess, and it is not recommended for children under 2 years old or those with certain medical conditions. Adherence to these guidelines is essential for maintaining consumer trust and regulatory compliance[5].

Market Performance and Sales

IMODIUM has been one of the top-selling OTC medications in various markets. In Great Britain, for example, IMODIUM was one of the biggest-selling branded OTC medications in 2016, with sales of £32.7 million. The brand's strong performance is a testament to its effectiveness and consumer preference[3].

Competitive Landscape

The OTC anti-diarrheal market is competitive, with several brands and generic options available. However, IMODIUM MULTI-SYMPTOM RELIEF stands out due to its unique formulation and broad symptom relief. The brand's marketing and distribution strategies, including its presence in major pharmacies and online platforms, also contribute to its competitive edge[5].

Future Outlook

The future outlook for IMODIUM MULTI-SYMPTOM RELIEF appears positive, driven by consistent consumer demand and the medication's proven efficacy. As the healthcare landscape continues to evolve, the importance of accessible and effective OTC treatments will remain high. However, the brand must navigate potential regulatory changes and competition from new entrants in the market.

Impact of Broader Healthcare Trends

While IMODIUM MULTI-SYMPTOM RELIEF operates within the specific niche of anti-diarrheal medications, broader healthcare trends can influence its market dynamics. For instance, the growing focus on preventive care and self-management of health conditions could increase demand for reliable OTC medications like IMODIUM.

Consumer Behavior and Lifestyle Changes

Changes in consumer behavior, such as increased health awareness and a preference for multi-symptom relief products, also play a role. The combination of loperamide and simethicone in IMODIUM MULTI-SYMPTOM RELIEF aligns well with these trends, as consumers seek comprehensive solutions for their health issues.

Key Takeaways

• Pricing and Cost Factors: The cost of IMODIUM MULTI-SYMPTOM RELIEF varies based on formulation, pharmacy, and whether it is a generic or brand-name version.
• Generic Competition: Generic versions of loperamide are available and offer a cost-effective alternative.
• Financial Assistance: Various programs are available to help reduce the cost of the medication.
• Consumer Demand: Consistent demand due to the common nature of gastrointestinal issues.
• Regulatory Environment: The medication has a relatively favorable regulatory status but faces potential changes due to misuse concerns.
• Safety and Usage Guidelines: Adherence to guidelines is crucial for maintaining consumer trust and regulatory compliance.
• Market Performance and Sales: IMODIUM has a strong sales record and is one of the top-selling OTC medications in several markets.
• Competitive Landscape: The brand's unique formulation and broad symptom relief give it a competitive edge.

FAQs

Q: What are the active ingredients in IMODIUM MULTI-SYMPTOM RELIEF?

A: The active ingredients are loperamide HCl (2 mg per caplet) for anti-diarrheal relief and simethicone (125 mg per caplet) for anti-gas relief[5].

Q: Why is there a cost difference between brand-name IMODIUM and generic loperamide?

A: Brand-name drugs are more expensive due to the extensive research and testing required for their development. Generic drugs, which contain the same active ingredients, do not require this testing and are therefore cheaper[1][4].

Q: Are there any financial assistance programs available for IMODIUM?

A: Yes, various financial assistance programs and savings cards are available to help reduce the cost of IMODIUM. Websites like NeedyMeds provide details on these programs[1].

Q: What are the potential side effects of IMODIUM MULTI-SYMPTOM RELIEF?

A: Potential side effects include tiredness, drowsiness, dizziness, and in rare cases, serious heart problems if taken in excess. It is also important to follow the recommended dosage and usage guidelines[5].

Q: Can children use IMODIUM MULTI-SYMPTOM RELIEF?

A: The medication is not recommended for children under 2 years old. For children between 2 and 11 years old, the dosage should be carefully followed as per the product instructions, and for children under 6 years old, it is advised to consult a doctor before use[5].

Sources

1. Healthline: Imodium (Loperamide) Cost and Financial Assistance.
2. Morgan Stanley: Scaling Up the Impact of Obesity Drugs.
3. Wikipedia: Loperamide.
4. MedicalNewsToday: Imodium cost: Savings options and more.
5. IMODIUM: IMODIUM® Multi-Symptom Relief Anti-Diarrheal Medicine Caplets.