Loperamide hydrochloride - Generic Drug Details

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What are the generic drug 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, Bionpharma Inc, Mylan, Roxane, Teva, Yaopharma Co Ltd, Janssen Pharms, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Hi Tech Pharma, Perrigo, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, Able, Aurobindo Pharma Ltd, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, and Sun Pharm Inds Ltd, and is included in thirty-three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for loperamide hydrochloride

US Patents:	1
Tradenames:	6
Applicants:	22
NDAs:	33
Drug Master File Entries:	11
Suppliers / Packagers:	116
Bulk Api Vendors:	89
Clinical Trials:	60
Patent Applications:	5,478
Formulation / Manufacturing:	see details
DailyMed Link:	loperamide hydrochloride at DailyMed

Recent Clinical Trials for loperamide hydrochloride

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

Sponsor	Phase
OrphoMed, Inc.	Phase 2
PPD	Phase 2
National Cancer Institute (NCI)	Phase 1

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

Synonyms for loperamide hydrochloride

1-Piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-alpha,alpha-diphenyl-, hydrochloride
1-Piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-alpha,alpha-diphenyl-, monohydrochloride
1-Piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-alpha,alpha-diphenyl-,hydrochloride
34552-83-5
4-(4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl)-N,N-dimethyl-2,2-diphenylbutanamide hydrochloride
4-(4-(p-Chlorophenyl)-4-hydroxy-1-piperidyl)-N,N-dimethyl-2,2-diphenylbutyramide HCl
4-(4-chlorophenyl)-1-[4-(dimethylamino)-4-oxo-3,3-diphenylbutyl]-4-hydroxypiperidin-1-ium chloride
4-(4-chlorophenyl)-4-hydroxy- N,N-dimethyl-alpha,alpha-diphenyl- 1-piperidine butanamide
4-(4-Chlorophenyl)-4-hydroxy-N,.alpha.-diphenyl-1-piperidinebutanamide monohydrochloride
4-(4-Chlorophenyl)-4-hydroxy-N,N-dimethyl-?,?-diphenyl-1-piperidinebutanamide hydrochloride
4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-alpha,alpha-diphenyl-1-piperidine butanamide
4-(4-Chlorophenyl)-4-hydroxy-N,N-dimethyl-alpha,alpha-diphenylpiperidine-1-butyramide monohydrochloride
4-(p-Chlorophenyl)-4-hydroxy-N,N-dimethyl-alpha,alpha-diphenyl-1-piperidine butyramide HCl
4-(p-Chlorophenyl)-4-hydroxy-N,N-dimethyl-alpha,alpha-diphenyl-1-piperidinebutyramide hydrochloride
4-(p-Chlorophenyl)-4-hydroxy-N,N-dimethyl-alpha,alpha-diphenyl-1-piperidinebutyramide monohydrochloride
4-[4-(4-chlorophenyl)-4-hydroxy-1-piperidinyl]-N,N-dimethyl-2,2-diphenylbutanamide hydrochloride
4-[4-(4-chlorophenyl)-4-hydroxy-1-piperidyl]-N,N-dimethyl-2,2-diphenyl-butanamide hydrochloride
4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide hydrochloride
4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-n,n-dimethyl-2,2-diphenylbutanamide;hydrochloride
4-[4-(4-chlorophenyl)-4-oxidanyl-piperidin-1-yl]-N,N-dimethyl-2,2-diphenyl-butanamide hydrochloride
53179-11-6 (Parent)
552L835
77TI35393C
A822272
AB0013105
AB2000588
AC-8242
AC1L2G4W
AC1Q3BBG
AKOS015846351
AN-8179
Anti-diarrheal
ARONIS27197
AS-13181
B1392
BC205117
BCP28441
BLOX
BREK
C29H33ClN2O2.HCl
C29H34Cl2N2O2
CCG-39494
CHEBI:6533
CHEMBL1707
CPD000058466
CS-2522
D00729
Diamode
Diar-Aid
Dissenten
EBD2202345
EINECS 252-082-4
EU-0100708
Fortasec
FT-0627973
H536
HMS1568M10
HMS1922J18
HY-B0418A
I06-0646
Imodium
Imodium (TN)
Imodium A-D
Imodium A-D EZ chews
Imosec
Imotil
K-7865
K-Pek II
Kao-Paverin
Kaopectate 1-D
KS-00000GHZ
KS-000048OI
L 4762
L0154
Lopemid
Lopemin
Loperamide Hydrochloride ,(S)
Loperamide (hydrochloride)
Loperamide HCl
Loperamide hydrochloride (JAN/USP)
Loperamide hydrochloride [USAN:JAN]
Loperamide hydrochloride [USAN:USP:JAN]
Loperamide Hydrochloride Capsules
Loperamide hydrochloride for system suitability, European Pharmacopoeia (EP) Reference Standard
Loperamide hydrochloride, British Pharmacopoeia (BP) Reference Standard
Loperamide hydrochloride, European Pharmacopoeia (EP) Reference Standard
Loperamide hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Loperamide hydrochloride, United States Pharmacopeia (USP) Reference Standard
Loperamide hydrochloride, VETRANAL(TM), analytical standard
Loperamide, HCl
Loperyl
Loseramin
LP00708
LS-114353
Maalox Antidiarrheal
MCULE-8938403173
MFCD00058581
MLS000069779
MLS001148627
MLS002222200
MolPort-003-666-775
NC00572
NCGC00094059-01
NCGC00094059-02
NCGC00094059-03
NCGC00094059-04
NCGC00094059-05
NCGC00180886-01
NCGC00180886-02
NCGC00261393-01
NSC-696356
NSC-759568
NSC696356
NSC759568
Opera_ID_1508
Pepto Diarrhea Control
PGYPOBZJRVSMDS-UHFFFAOYSA-N
Pharmakon1600-02300241
PJ185
Prestwick_302
R 18,553
R 18553
REGID_for_CID_71420
s2480
SAM002564218
SCHEMBL15048
SMR000058466
SPECTRUM2300241
SR-01000075507
SR-01000075507-1
SR-01000075507-3
SR-01000075507-8
Suprasec
SW196602-3
Tebloc
TL8002575
Tox21_500708
UNII-77TI35393C
Up and up anti diarrheal
W-106729

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
J And J Consumer Inc	IMODIUM A-D	loperamide hydrochloride	SUSPENSION;ORAL	019487-002	Jul 8, 2004		OTC	Yes	Yes	Start Trial	Start Trial				Start Trial
Sun Pharm Inds Ltd	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	077500-001	Sep 6, 2006		OTC	No	No	Start Trial	Start Trial				Start Trial
Perrigo	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	074194-001	Oct 30, 1992		DISCN	No	No	Start Trial	Start Trial				Start Trial
Teva	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	SOLUTION;ORAL	073478-001	Jun 23, 1995		DISCN	No	No	Start Trial	Start Trial				Start Trial
Contract Pharmacal	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	073254-001	Jul 30, 1993		DISCN	No	No	Start Trial	Start Trial				Start Trial
J And J Consumer Inc	IMODIUM	loperamide hydrochloride	CAPSULE;ORAL	017690-001	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
>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	loperamide hydrochloride	CAPSULE;ORAL	017694-001	Approved Prior to Jan 1, 1982	Start Trial	Start Trial
J And J Consumer Inc	IMODIUM A-D EZ CHEWS	loperamide hydrochloride	TABLET, CHEWABLE;ORAL	020448-001	Jul 24, 1997	Start Trial	Start Trial
J And J Consumer Inc	IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988	Start Trial	Start Trial
Janssen Pharms	IMODIUM	loperamide hydrochloride	SOLUTION;ORAL	019037-001	Jul 31, 1984	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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