LOPERAMIDE Drug Patent Profile

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

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Which patents cover Loperamide, and what generic alternatives are available?

Loperamide is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Onesource Specialty, Roxane, Rubicon Research, Teva, Zydus Lifesciences, 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 NDAs.

The generic ingredient in LOPERAMIDE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Loperamide

A generic version of LOPERAMIDE was approved as loperamide hydrochloride; simethicone by PERRIGO R AND D on September 5^th, 2018.

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Summary for LOPERAMIDE

US Patents:	0
Applicants:	30
NDAs:	40
Drug Prices:	Drug price information for LOPERAMIDE
Drug Sales Revenues:	Drug sales revenues for LOPERAMIDE
DailyMed Link:	LOPERAMIDE at DailyMed

Drug patent expirations by year for LOPERAMIDE

US Patents and Regulatory Information for LOPERAMIDE

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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
Sun Pharm Inds Ltd	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	077500-001	Sep 6, 2006		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ohm Labs	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	074091-001	Dec 10, 1992		OTC	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Contract Pharmacal	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	073254-001	Jul 30, 1993		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Perrigo	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	074194-001	Oct 30, 1992		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
L Perrigo Co	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	075232-001	Jan 6, 2000		OTC	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Aurobindo Pharma	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	220372-001	Dec 29, 2025		OTC	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Bionpharma	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	220100-001	Sep 19, 2025		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

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