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Last Updated: December 11, 2019

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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.

Recent Clinical Trials for loperamide hydrochloride

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

SponsorPhase
OrphoMed, Inc.Phase 2
PPDPhase 2
National Cancer Institute (NCI)Phase 1

See all loperamide hydrochloride clinical trials

Pharmacology for loperamide hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for loperamide hydrochloride
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

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

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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Baxter
Colorcon

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