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IMODIUM Drug Profile

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Which patents cover Imodium, and what substitute generic drugs are available?

Imodium is a drug marketed by Janssen Pharms and J And J Consumer Inc and is included in eight NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in IMODIUM is loperamide hydrochloride; simethicone. There are eleven 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

Patents:0
Applicants:2
NDAs:8
Bulk Api Vendors: see list85
Clinical Trials: see list11
Patent Applications: see list4,572
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:IMODIUM at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
IMODIUM
loperamide hydrochloride
SOLUTION;ORAL019037-001Jul 31, 1984DISCNNoNo► Subscribe► Subscribe
J And J Consumer Inc
IMODIUM A-D EZ CHEWS
loperamide hydrochloride
TABLET, CHEWABLE;ORAL020448-001Jul 24, 1997DISCNYesNo6,814,978► SubscribeY ► Subscribe
J And J Consumer Inc
IMODIUM A-D
loperamide hydrochloride
TABLET;ORAL019860-001Nov 22, 1989OTCYesYes► Subscribe► Subscribe
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL020606-001Jun 26, 1996DISCNYesNo► Subscribe► Subscribe
J And J Consumer Inc
IMODIUM
loperamide hydrochloride
CAPSULE;ORAL017690-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
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Expired Patents for Tradename: IMODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
IMODIUM
loperamide hydrochloride
SOLUTION;ORAL019037-001Jul 31, 19843,714,159► Subscribe
J And J Consumer Inc
IMODIUM
loperamide hydrochloride
CAPSULE;ORAL017694-001Approved Prior to Jan 1, 19823,714,159► Subscribe
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Paragraph IV activity for: IMODIUM

Drugname Dosage Strength RLD Submissiondate
loperamide hydrochloride and simethiconeTablets2 mg/125 mgImodium Advanced12/29/2004
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