Loperamide hydrochloride; simethicone - Generic Drug Details

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, Granules, Guardian Drug, Hetero Labs Ltd V, Perrigo R And D, and Sun Pharm Inds Ltd, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-eight suppliers are listed for this compound.

Summary for loperamide hydrochloride; simethicone

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	10
Finished Product Suppliers / Packagers:	28
Clinical Trials:	5
DailyMed Link:	loperamide hydrochloride; simethicone at DailyMed

Recent Clinical Trials for loperamide hydrochloride; 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; simethicone clinical trials

Pharmacology for loperamide hydrochloride; simethicone

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

Anatomical Therapeutic Chemical (ATC) Classes for loperamide hydrochloride; simethicone

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

Paragraph IV (Patent) Challenges for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMODIUM MULTI-SYMPTOM RELIEF	Tablets	loperamide hydrochloride; simethicone	2 mg/125 mg	021140		2004-12-29

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
Granules	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	215981-001	Aug 29, 2022		OTC	No	No
Perrigo	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	076029-001	Aug 30, 2002		DISCN	No	No
Aurobindo Pharma Ltd	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	211059-001	Dec 14, 2020		OTC	No	No
Perrigo R And D	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	209837-001	Sep 5, 2018		OTC	No	No

Expired US Patents for loperamide hydrochloride; simethicone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET;ORAL	021140-001	Nov 30, 2000