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Last Updated: January 22, 2020

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IMODIUM Drug Profile

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Which patents cover Imodium, and when can generic versions of Imodium launch?

Imodium is a drug marketed by J And J Consumer Inc and Janssen Pharms and is included in eight NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in IMODIUM is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

US ANDA Litigation and Generic Entry Outlook for Imodium

  Start Trial

Imodium was eligible for patent challenges on December 31st, 1968.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Drug patent expirations by year for IMODIUM
Recent Clinical Trials for IMODIUM

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

SponsorPhase
University of North Carolina, Chapel HillPhase 2
AllerganPhase 2
M.D. Anderson Cancer CenterPhase 1

See all IMODIUM clinical trials

Synonyms for IMODIUM
1-Piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-.alpha.,.alpha.-diphenyl-
1-Piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-alpha,alpha-diphenyl-
179L116
2-methoxyethyl1-methylethyl2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
34552-83-5 (mono-hydrochloride)
4-(4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl)-N,N-dimethyl-2,2-diphenylbutanamide
4-(4-Chlorophenyl)-N,N-dimethyl-.alpha.,.alpha.-diphenyl-4-hydroxy-1-piperidinebutanamide
4-(4-Chlorophenyl)-N,N-dimethyl-alpha,alpha-diphenyl-4-hydroxy-1-piperidinebutanamide
4-(p-Chlorophenyl)-4-hydroxy-N,N-dimethyl-.alpha.,.alpha.-diphenyl-1-piperidinebutyramide
4-[4-(4-Chloro-phenyl)-4-hydroxy-piperidin-1-yl]-N,N-dimethyl-2,2-diphenyl-butyramide
4-[4-(4-Chloro-phenyl)-4-hydroxy-piperidin-1-yl]-N,N-dimethyl-2,2-diphenyl-butyramide(loperamide)
4-[4-(4-Chlorophenyl)-4-hydroxy-1-piperidinyl]-N,N-dimethyl-2,2-diphenylbutanamide
4-[4-(4-Chlorophenyl)-4-hydroxy-1-piperidinyl]-N,N-dimethyl-2,2-diphenylbutanamide #
4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide
4-[4-(4-chlorophenyl)-4-hydroxypiperidyl]-N,N-dimethyl-2,2-diphenylbutanamide
4-[4-(4-chlorophenyl)-4-oxidanyl-piperidin-1-yl]-N,N-dimethyl-2,2-diphenyl-butanamide
5-21-02-00379 (Beilstein Handbook Reference)
53179-11-6
6X9OC3H4II
A829430
AB00053697
AB00053697_14
AB00053697_15
AB00053697-12
AB00053697-13
AC1L1H38
AJ-23375
AKOS000573892
AN-40881
ANW-42343
API0003209
Apo-Loperamide
AX8136655
BAS 01889668
BDBM50017698
Bio1_000082
Bio1_000571
Bio1_001060
Bio2_000101
Bio2_000581
BPBio1_000274
BRD-K61250553-001-02-9
BRD-K61250553-003-05-8
BRD-K61250553-003-16-5
BRN 1558273
BSPBio_000248
BSPBio_001381
BSPBio_002769
C07080
C29H33ClN2O2
CAS-34552-83-5
CAS-53179-11-6
CBiol_001796
CCG-204793
CHEBI:6532
CHEMBL841
cid_71420
CTK8B3344
D08144
DB00836
Diamide (TN)
Diarr-Eze
DivK1c_000215
DSSTox_CID_25165
DSSTox_GSID_45165
DSSTox_RID_80715
DTXSID6045165
EC 258-416-5
EINECS 258-416-5
FT-0657293
GTPL7215
HMS1791F03
HMS1989F03
HMS2089C13
HSDB 8344
IDI1_000215
IDI1_033851
Immodium
Imodium A-D
Imodium A-D Caplets
Ioperamide
Kaopectate II
KB-238040
KBio1_000215
KBio2_000101
KBio2_000854
KBio2_002669
KBio2_003422
KBio2_005237
KBio2_005990
KBio3_000201
KBio3_000202
KBio3_001989
KBioGR_000101
KBioGR_001685
KBioSS_000101
KBioSS_000854
L000709
Lopac-L-4762
Lopac0_000708
Loperacap
Loperamid
Loperamida
Loperamida [INN-Spanish]
loperamide
Loperamide (INN)
Loperamide [INN:BAN]
Loperamide Monohydrochloride
Loperamidum
Loperamidum [INN-Latin]
LS-114352
Maalox Anti-Diarrheal
MCULE-3957783776
NCGC00015608-01
NCGC00015608-02
NCGC00015608-03
NCGC00015608-04
NCGC00015608-05
NCGC00015608-06
NCGC00015608-07
NCGC00015608-08
NCGC00015608-09
NCGC00015608-11
NCGC00016828-01
NCGC00024818-01
NCGC00024818-02
NCGC00024818-03
NCGC00024818-04
NCGC00024818-05
NINDS_000215
Nu-Loperamide
Oprea1_109220
Pepto Diarrhea Control
PMS-Loperamide
Prestwick0_000144
Prestwick1_000144
Prestwick2_000144
Prestwick3_000144
R-18553
RDOIQAHITMMDAJ-UHFFFAOYSA-N
Rho-Loperamide
SBI-0050686.P003
SCHEMBL28530
SPBio_001816
SPBio_002187
Spectrum_000374
Spectrum2_001738
Spectrum3_001015
Spectrum4_001143
Spectrum5_001374
ST095179
STK042086
TC-070956
Tocris-0840
Tox21_110180
Tox21_110180_1
UNII-6X9OC3H4II
VA11195
ZINC537928

US Patents and Regulatory Information for IMODIUM

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 loperamide hydrochloride CAPSULE;ORAL 017690-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
J And J Consumer Inc IMODIUM A-D EZ CHEWS loperamide hydrochloride TABLET, CHEWABLE;ORAL 020448-001 Jul 24, 1997 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
J And J Consumer Inc IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487-001 Mar 1, 1988 OTC Yes Yes   Start Trial   Start Trial   Start Trial
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET, CHEWABLE;ORAL 020606-001 Jun 26, 1996 DISCN Yes 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 IMODIUM

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
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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Colorcon
Harvard Business School
AstraZeneca
Merck

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