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Last Updated: March 19, 2024

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, Aurobindo Pharma Ltd, Bionpharma, Granules, Guardian Drug, Hetero Labs Ltd V, Perrigo R And D, and Sun Pharm Inds Ltd, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-two 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
Rocky Mountain MS Research Group, LLCPhase 4
BiogenPhase 4

See all LOPERAMIDE HYDROCHLORIDE; SIMETHICONE clinical trials

Pharmacology for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Physiological EffectSkin Barrier Activity
Paragraph IV (Patent) Challenges for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
IMODIUM MULTI-SYMPTOM RELIEF Tablets loperamide hydrochloride; simethicone 2 mg/125 mg 021140 2004-12-29

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
Sun Pharm Inds Ltd LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 077500-001 Sep 6, 2006 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 209837-001 Sep 5, 2018 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 211438-001 Jun 17, 2021 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET, CHEWABLE;ORAL 076029-001 Aug 30, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET, CHEWABLE;ORAL 020606-001 Jun 26, 1996 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 213484-001 Sep 10, 2021 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Guardian Drug LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 214541-001 May 27, 2021 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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