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 patent protection?

Loperamide hydrochloride; simethicone is the generic ingredient in two branded drugs marketed by J And J Consumer Inc, 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 ten NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-one suppliers are listed for this compound.

Summary for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	10
Finished Product Suppliers / Packagers:	31
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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Perrigo R And D	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	209837-001	Sep 5, 2018		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Granules	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	215981-001	Aug 29, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	211438-001	Jun 17, 2021		OTC	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

Expired US Patents for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

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

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