Loperamide hydrochloride - Generic Drug Details

What are the generic drug sources for loperamide hydrochloride and what is the scope of patent protection?

Loperamide hydrochloride is the generic ingredient in six branded drugs marketed by J And J Consumer Inc, Bionpharma Inc, Chartwell Rx, Edenbridge Pharms, Mylan, Roxane, Strides Pharma, Teva, Janssen Pharms, Akorn, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Perrigo, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, Able, Aurobindo Pharma Ltd, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for loperamide hydrochloride. Ninety-nine suppliers are listed for this compound.

Summary for loperamide hydrochloride

US Patents:	0
Tradenames:	6
Applicants:	26
NDAs:	40
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	99
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	74
Patent Applications:	7,038
Formulation / Manufacturing:	see details
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
Spanish Breast Cancer Research Group	Phase 2
Pierre Fabre Laboratories	Phase 2
Chinese Academy of Medical Sciences	Phase 2

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roxane	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	073080-001	Nov 27, 1991		DISCN	No	No
Perrigo	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	073243-001	Jan 21, 1992		OTC	No	No
Chartwell Rx	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	072993-001	Aug 28, 1992		DISCN	No	No
Wockhardt Bio Ag	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	074730-001	Aug 28, 1997		OTC	No	No
Contract Pharmacal	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	073254-001	Jul 30, 1993		DISCN	No	No
Teva	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	073478-001	Jun 23, 1995		DISCN	No	No
J And J Consumer Inc	IMODIUM	loperamide hydrochloride	CAPSULE;ORAL	017690-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for loperamide hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	IMODIUM	loperamide hydrochloride	CAPSULE;ORAL	017694-001	Approved Prior to Jan 1, 1982
J And J Consumer Inc	IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988
Janssen Pharms	IMODIUM	loperamide hydrochloride	SOLUTION;ORAL	019037-001	Jul 31, 1984
J And J Consumer Inc	IMODIUM A-D EZ CHEWS	loperamide hydrochloride	TABLET, CHEWABLE;ORAL	020448-001	Jul 24, 1997
J And J Consumer Inc	IMODIUM A-D EZ CHEWS	loperamide hydrochloride	TABLET, CHEWABLE;ORAL	020448-001	Jul 24, 1997