Loperamide hydrochloride - Generic Drug Details

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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, 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 six 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:	106
Bulk Api Vendors:	89
Clinical Trials:	65
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
Jiangsu HengRui Medicine Co., Ltd.	Phase 1
SOLTI Breast Cancer Research Group	Phase 1
Roche Pharma AG	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,.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-a,a-diphenylpiperidine-1-butyramide monohydrochloride
4-(4-Chlorophenyl)-4-hydroxy-N,N-dimethyl-alpha,alpha-diphenyl-1-piperidinebutanamidehydrochloride
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-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
552L835
77TI35393C
A822272
AB0013105
AB2000588
AC-8242
ADL 2-1294
AK550233
AKOS015846351
Anti-diarrheal
ARONIS27197
AS-13181
B1392
BCP28441
BLOX
BREK
C29H33ClN2O2.HCl
C29H34Cl2N2O2
CCG-39494
CHEBI:6533
CHEMBL1707
CPD000058466
CS-2522
D00729
Diamode
Diar-Aid
Dissenten
DTXSID00880006
EBD2202345
EINECS 252-082-4
EU-0100708
Fortasec
FT-0627973
H536
HMS1568M10
HMS1922J18
HY-B0418A
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-hydrochloride
Loperamide, HCl
Loperyl
Loseramin
LP00708
LS-114353
Maalox Anti-Diarrheal
Maalox Antidiarrheal
MCULE-8938403173
MFCD00058581
MLS000069779
MLS001148627
MLS002222200
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
Q27107231
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
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
Ohm Labs	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	TABLET;ORAL	074091-001	Dec 10, 1992		OTC	No	No	Start Trial	Start Trial				Start Trial
Roxane	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	073080-001	Nov 27, 1991		DISCN	No	No	Start Trial	Start Trial				Start Trial
J And J Consumer Inc	IMODIUM A-D	loperamide hydrochloride	TABLET;ORAL	019860-001	Nov 22, 1989		OTC	Yes	Yes	Start Trial	Start Trial				Start Trial
Yaopharma Co Ltd	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	072993-001	Aug 28, 1992		DISCN	No	No	Start Trial	Start Trial				Start Trial
Mylan	LOPERAMIDE HYDROCHLORIDE	loperamide hydrochloride	CAPSULE;ORAL	072741-001	Sep 18, 1991	AB	RX	No	Yes	Start Trial	Start Trial				Start Trial
Perrigo R And D	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	loperamide hydrochloride; simethicone	TABLET;ORAL	209837-001	Sep 5, 2018		OTC	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 A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988	Start Trial	Start Trial
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
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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