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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

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

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

Summary for IMODIUM

US Patents:	0
Applicants:	2
NDAs:	8
Bulk Api Vendors:	38
Clinical Trials:	20
Patent Applications:	4,003
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for IMODIUM
DailyMed Link:	IMODIUM at DailyMed

Recent Clinical Trials for IMODIUM

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 2
Allergan	Phase 2
M.D. Anderson Cancer Center	Phase 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
J And J Consumer Inc	IMODIUM A-D EZ CHEWS	loperamide hydrochloride	TABLET, CHEWABLE;ORAL	020448-001	Jul 24, 1997		DISCN	Yes	No			Y
J And J Consumer Inc	IMODIUM A-D	loperamide hydrochloride	SOLUTION;ORAL	019487-001	Mar 1, 1988		OTC	Yes	Yes
J And J Consumer Inc	IMODIUM MULTI-SYMPTOM RELIEF	loperamide hydrochloride; simethicone	TABLET, CHEWABLE;ORAL	020606-001	Jun 26, 1996		DISCN	Yes	No

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
Janssen Pharms	IMODIUM	loperamide hydrochloride	SOLUTION;ORAL	019037-001	Jul 31, 1984