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Last Updated: November 2, 2024

LOPERAMIDE HYDROCHLORIDE Drug Patent Profile

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When do Loperamide Hydrochloride patents expire, and what generic alternatives are available?

Loperamide Hydrochloride is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Roxane, Rubicon, Strides Pharma, Teva, Zydus Lifesciences, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Perrigo, Sciegen Pharms Inc, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, Able, Aurobindo Pharma, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd. and is included in thirty-seven NDAs.

The generic ingredient in LOPERAMIDE HYDROCHLORIDE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-one 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 Hydrochloride

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

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Summary for LOPERAMIDE HYDROCHLORIDE

US Patents:	0
Applicants:	29
NDAs:	37
Finished Product Suppliers / Packagers:	103
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	76
Patent Applications:	3,264
DailyMed Link:	LOPERAMIDE HYDROCHLORIDE at DailyMed

Drug patent expirations by year for LOPERAMIDE HYDROCHLORIDE

Recent Clinical Trials for LOPERAMIDE HYDROCHLORIDE

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

Sponsor	Phase
Uniformed Services University of the Health Sciences	Phase 4
Infectious Diseases Clinical Research Program	Phase 4
Henry M. Jackson Foundation for the Advancement of Military Medicine	Phase 4

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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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lnk	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	076497-001	Jun 10, 2003		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	213484-001	Sep 10, 2021		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ohm Labs	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	074091-001	Dec 10, 1992		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	218122-001	Sep 5, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Perrigo	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	073243-001	Jan 21, 1992		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Able	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	073528-001	Nov 30, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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