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Loperamide hydrochloride; simethicone - Generic Drug Details

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

There are eleven drug master file entries for loperamide hydrochloride; simethicone. Twenty-four suppliers are listed for this compound.

Summary for loperamide hydrochloride; simethicone

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	9
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	24
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
Rocky Mountain MS Research Group, LLC	Phase 4
Biogen	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	NDA	Submissiondate
IMODIUM MULTI-SYMPTOM RELIEF	TABLET;ORAL	loperamide hydrochloride; simethicone	021140	2004-12-29
IMODIUM MULTI-SYMPTOM RELIEF	TABLET, CHEWABLE;ORAL	loperamide hydrochloride; simethicone	020606

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
Aurobindo Pharma Ltd	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	211059-001	Dec 14, 2020		OTC	No	No
Perrigo	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	076029-001	Aug 30, 2002		OTC	No	Yes
Guardian Drug	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	214541-001	May 27, 2021		OTC	No	No
Bionpharma Inc	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	213484-001	Sep 10, 2021		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, 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