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Profile for Tradename: IMODIUM MULTI-SYMPTOM RELIEF

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Imodium Multi-symptom Relief is a drug marketed by Mcneil and Mcneil Cons and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug.

This drug has twenty-eight patent family members in nineteen countries.

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

Summary for Tradename: IMODIUM MULTI-SYMPTOM RELIEF

Patents:2
Applicants:2
NDAs:2
Suppliers / Packagers: see list5
Formulation / Manufacturing:see details

Clinical Trials for: IMODIUM MULTI-SYMPTOM RELIEF

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mcneil
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL020606-001Jun 26, 1996OTCYes5,679,376<disabled>Y<disabled>
Mcneil Cons
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET;ORAL021140-001Nov 30, 2000OTCYes6,103,260<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: IMODIUM MULTI-SYMPTOM RELIEF

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,599,577 Simethicone containing pharmaceutical compositions<disabled in preview>
5,980,944 Simethicone containing pharmaceutical compositions<disabled in preview>
5,716,641 Simethicone containing pharmaceutical compositions<disabled in preview>
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International Patent Family for Tradename: IMODIUM MULTI-SYMPTOM RELIEF

Country Document Number Publication Date
Austria259236Feb 15, 2004
Greece93100197Jan 31, 1994
Poland189988Oct 31, 2005
Germany69315257May 14, 1998
Czech Republic9802221Feb 17, 1999
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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