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Details for Generic Name: loperamide hydrochloride; simethicone

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Loperamide hydrochloride; simethicone is the generic ingredient in two branded drugs marketed by J And J Consumer Inc, Perrigo, and Sun Pharm Inds Ltd, and is included in four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are ten drug master file entries for loperamide hydrochloride; simethicone. One supplier is listed for this compound.

Summary for Generic Name: loperamide hydrochloride; simethicone

Tradenames:2
Patents:2
Applicants:3
NDAs:4
Drug Master File Entries: see list10
Suppliers / Packaging: see list5

Clinical Trials for: loperamide hydrochloride; simethicone

Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Status: Completed Condition: Diarrhea

Bioequivalence Study of Loperamide Hydrochloride 2 mg and Simethicone 125 mg Tablet Under Fasting Conditions
Status: Completed Condition: Healthy

Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
Status: Terminated Condition: Relapsing Remitting Multiple Sclerosis

A Comparison of Three Medications to Treat Diarrhea in Adults.
Status: Completed Condition: Diarrhea

Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea
Status: Completed Condition: Diarrhea

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL020606-001Jun 26, 1996OTCYes5,679,376<disabled>Y <disabled>
Perrigo
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL076029-001Aug 30, 2002OTCNo<disabled><disabled>
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET;ORAL021140-001Nov 30, 2000OTCYes6,103,260<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: loperamide hydrochloride; simethicone

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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;ORAL020606-001Jun 26, 19965,248,505<disabled>
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET;ORAL021140-001Nov 30, 20005,612,054<disabled>
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL020606-001Jun 26, 19965,716,641<disabled>
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International Patent Family for Ingredient: loperamide hydrochloride; simethicone

Country Document Number Publication Date
Spain2216244Oct 16, 2004
Brazil9802487Sep 08, 1999
Germany69821553Mar 18, 2004
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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.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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