LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE Drug Patent Profile

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

Loperamide Hydrochloride And Simethicone is a drug marketed by 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 eight NDAs.

The generic ingredient in LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 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 And Simethicone

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

Summary for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
DailyMed Link:	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE at DailyMed

Recent Clinical Trials for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

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

Sponsor	Phase
McNeil AB	Phase 1
Biogen	Phase 4
Rocky Mountain MS Research Group, LLC	Phase 4

See all LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE clinical trials

Pharmacology for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists
Physiological Effect	Skin Barrier Activity

US Patents and Regulatory Information for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Perrigo	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	076029-001	Aug 30, 2002		DISCN	No	No
Perrigo R And D	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	209837-001	Sep 5, 2018		OTC	No	No
Granules	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	215981-001	Aug 29, 2022		DISCN	No	No
Sun Pharm Inds Ltd	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	077500-001	Sep 6, 2006		DISCN	No	No
Aurobindo Pharma Ltd	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	211059-001	Dec 14, 2020		OTC	No	No
Bionpharma	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	213484-001	Sep 10, 2021		OTC	No	No
Hetero Labs Ltd V	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	211438-001	Jun 17, 2021		OTC	No	No