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Last Updated: January 19, 2022

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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 freedom to operate?

Loperamide hydrochloride; simethicone is the generic ingredient in two branded drugs marketed by J And J Consumer Inc, Perrigo, Aurobindo Pharma Ltd, Bionpharma Inc, Guardian Drug, Hetero Labs Ltd V, Perrigo R And D, and Sun Pharm Inds Ltd, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for loperamide hydrochloride; simethicone. Twenty-four 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 Action Opioid Agonists
Physiological Effect Skin Barrier Activity
Anatomical Therapeutic Chemical (ATC) Classes for loperamide hydrochloride; simethicone
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
Aurobindo Pharma Ltd LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 211059-001 Dec 14, 2020 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Perrigo LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET, CHEWABLE;ORAL 076029-001 Aug 30, 2002 OTC No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Guardian Drug LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 214541-001 May 27, 2021 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bionpharma Inc LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 213484-001 Sep 10, 2021 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Perrigo R And D LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE loperamide hydrochloride; simethicone TABLET;ORAL 209837-001 Sep 5, 2018 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Harvard Business School

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