LOPERAMIDE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for loperamide hydrochloride and what is the scope of freedom to operate?

Loperamide hydrochloride is the generic ingredient in six branded drugs marketed by J And J Consumer Inc, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Roxane, Rubicon, Strides Pharma, Teva, Zydus Lifesciences, Janssen Pharms, 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 forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for loperamide hydrochloride. One hundred and three suppliers are listed for this compound.

Summary for LOPERAMIDE HYDROCHLORIDE

US Patents:	0
Tradenames:	6
Applicants:	31
NDAs:	45
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	103
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	76
Patent Applications:	7,180
What excipients (inactive ingredients) are in LOPERAMIDE HYDROCHLORIDE?	LOPERAMIDE HYDROCHLORIDE excipients list
DailyMed Link:	LOPERAMIDE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for LOPERAMIDE HYDROCHLORIDE

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

Sponsor	Phase
Infectious Diseases Clinical Research Program	Phase 4
Henry M. Jackson Foundation for the Advancement of Military Medicine	Phase 4
Uniformed Services University of the Health Sciences	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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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
Perrigo	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	074194-001	Oct 30, 1992		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	073478-001	Jun 23, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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
Strides Pharma	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	213070-001	Aug 11, 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	IMODIUM A-D EZ CHEWS	loperamide hydrochloride	TABLET, CHEWABLE;ORAL	020448-001	Jul 24, 1997	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	IMODIUM	loperamide hydrochloride	CAPSULE;ORAL	017694-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	IMODIUM A-D EZ CHEWS	loperamide hydrochloride	TABLET, CHEWABLE;ORAL	020448-001	Jul 24, 1997	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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