Last Updated: June 9, 2026

Loperamide hydrochloride - Generic Drug Details

Name: loperamide hydrochloride Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic sources for loperamide hydrochloride and what is the scope of freedom to operate?

Loperamide hydrochloride is the generic ingredient in six branded drugs marketed by J And J Consumer Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Onesource Specialty, Roxane, Rubicon Research, Teva, Zydus Lifesciences, Janssen Pharms, Kenvue Brands, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Pai Holdings, Perrigo, Perrigo R And D, Watson Labs, Wockhardt Bio Ag, Able, Contract Pharmacal, L Perrigo Co, LNK, Marksans Pharma, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for loperamide hydrochloride. One hundred and three suppliers are listed for this compound.

Summary for loperamide hydrochloride

US Patents:	0
Tradenames:	6
Applicants:	33
NDAs:	48
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	103
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	84
Patent Applications:	7,460
What excipients (inactive ingredients) are in loperamide hydrochloride?	loperamide hydrochloride excipients list
DailyMed Link:	loperamide hydrochloride at DailyMed

Recent Clinical Trials for loperamide hydrochloride

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

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	NA
Jiangnan University	NA
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	NA

See all loperamide hydrochloride clinical trials

Pharmacology for loperamide hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Medical Subject Heading (MeSH) Categories for loperamide hydrochloride

Antidiarrheals

Anatomical Therapeutic Chemical (ATC) Classes for loperamide hydrochloride

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for loperamide hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bionpharma	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	213484-001	Sep 10, 2021		OTC	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Jubilant Cadista	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	217840-001	Jul 5, 2023	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Perrigo	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	076029-001	Aug 30, 2002		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Bionpharma	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	215579-001	Oct 22, 2021	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Perrigo R And D	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	091292-001	May 20, 2011		OTC	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Onesource Specialty	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	213070-001	Aug 11, 2021		OTC	No	No	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	IMODIUM	loperamide hydrochloride	CAPSULE;ORAL	017694-001	Approved Prior to Jan 1, 1982	3,714,159	⤷ Start Trial
Kenvue Brands	IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988	3,714,159	⤷ Start Trial
Janssen Pharms	IMODIUM	loperamide hydrochloride	SOLUTION;ORAL	019037-001	Jul 31, 1984	3,714,159	⤷ Start Trial
J And J Consumer Inc	IMODIUM A-D EZ CHEWS	loperamide hydrochloride	TABLET, CHEWABLE;ORAL	020448-001	Jul 24, 1997	6,814,978	⤷ Start Trial
J And J Consumer Inc	IMODIUM A-D EZ CHEWS	loperamide hydrochloride	TABLET, CHEWABLE;ORAL	020448-001	Jul 24, 1997	5,489,436	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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