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Last Updated: September 23, 2020

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LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - Generic Drug Details

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What are the generic drug sources for loperamide hydrochloride; simethicone and what is the scope of patent protection?

Loperamide hydrochloride; simethicone is the generic ingredient in two branded drugs marketed by J And J Consumer Inc, Perrigo, Perrigo R And D, and Sun Pharm Inds Ltd, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for loperamide hydrochloride; simethicone. Nineteen suppliers are listed for this compound.

Summary for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Recent Clinical Trials for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
McNeil ABPhase 1
BiogenPhase 4
Rocky Mountain MS Research Group, LLCPhase 4

See all LOPERAMIDE HYDROCHLORIDE; SIMETHICONE clinical trials

Paragraph IV (Patent) Challenges for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Tradename Dosage Ingredient NDA Submissiondate
IMODIUM MULTI-SYMPTOM RELIEF TABLET;ORAL loperamide hydrochloride; simethicone 021140 2004-12-29
IMODIUM MULTI-SYMPTOM RELIEF TABLET, CHEWABLE;ORAL loperamide hydrochloride; simethicone 020606

US Patents and Regulatory Information for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET, CHEWABLE;ORAL 076029-001 Aug 30, 2002 OTC No Yes   Start Trial   Start Trial   Start Trial
Perrigo R And D LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 209837-001 Sep 5, 2018 OTC No No   Start Trial   Start Trial   Start Trial
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET;ORAL 021140-001 Nov 30, 2000 OTC Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

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;ORAL 020606-001 Jun 26, 1996   Start Trial   Start Trial
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET;ORAL 021140-001 Nov 30, 2000   Start Trial   Start Trial
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET;ORAL 021140-001 Nov 30, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Express Scripts

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