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Loperamide hydrochloride; simethicone - Generic Drug Details

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

This ingredient has twenty patent family members in seventeen 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:1
Applicants:3
NDAs:4
Drug Master File Entries: see list10
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Clinical Trials for: loperamide hydrochloride; simethicone

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, 1996OTCYes<disabled><disabled>
Sun Pharm Inds Ltd
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
loperamide hydrochloride; simethicone
TABLET;ORAL077500-001Sep 6, 2006OTCNo<disabled><disabled>
Perrigo
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL076029-001Aug 30, 2002OTCNo<disabled><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, 19965,612,054<disabled>
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL020606-001Jun 26, 19965,679,376<disabled>
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET;ORAL021140-001Nov 30, 20005,248,505<disabled>
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International Patent Family for Ingredient: loperamide hydrochloride; simethicone

Country Document Number Estimated Expiration
Austria259236<disabled in preview>
Poland327491<disabled in preview>
Russian Federation2216317<disabled in preview>
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Supplementary Protection Certificates for Tradename: LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/013United Kingdom<disabled>PRODUCT NAME: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE; REGISTERED: UK 00242/0314 19970923
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