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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
Drug Prices:see low prices

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
Sun Pharm Inds Ltd
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
loperamide hydrochloride; simethicone
TABLET;ORAL077500-001Sep 6, 2006OTCNo
Perrigo
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL076029-001Aug 30, 2002OTCNo
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL020606-001Jun 26, 1996OTCYes
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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, CHEWABLE;ORAL020606-001Jun 26, 19965,716,641<disabled>
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL020606-001Jun 26, 19965,679,376<disabled>
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International Patent Family for Ingredient: loperamide hydrochloride; simethicone

Country Document Number Estimated Expiration
Hungary9801615<disabled in preview>
Czech Republic9802221<disabled in preview>
Brazil9802487<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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