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NDA

LOPERAMIDE HYDROCHLORIDE | N017694 | JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

5 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from MonoSol Rx, LLC FDA-2006-P-0212 · 8 docket documents MonoSol Rx, LLC filed this citizen petition under section 505(j)(2)(C) requesting that the FDA determine loperamide hydrochloride 2 mg orally dissolving film strip is suitable for an ANDA, with the reference listed drug being loperamide hydrochloride 2 mg oral chewable tablet approved under NDA 20-4	Other	2024-07-09	Open	MonoSol Rx, LLC
Suitability Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2023-P-4873 · 7 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Loperamide HCl Capsules in 1 mg and 4 mg strengths suitable for submission as an Abbreviated New Drug Application, with Johns	Suitability	2023-11-03	Denied	HYMAN, PHELPS & MCNAMARA, P.C.
Suitability Petition from Hyman, Phelps & McNamara, PC FDA-2020-P-1730 · 6 docket documents The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that FDA declare Loperamide HCl Capsules in 1 mg and 4 mg strengths suitable for submissio	Suitability	2020-08-04	Denied	Hyman, Phelps & McNamara, PC
Citizens Petition from Banner Pharmacaps Inc. FDA-2002-P-0134 · 4 docket documents Banner Pharmacaps Inc. filed this citizen petition on August 5, 2002, requesting that the FDA permit the filing of an Abbreviated New Drug Application for Loperamide Hydrochloride 2 mg soft gelatin capsules, which differs in dosage form from the Reference Listed Drug Imodium A-D tablets, pursuant to	Other	2009-11-17	Withdrawn	Banner Pharmacaps Inc.
Citizens Petition from Banner Pharmacaps Inc. FDA-2002-P-0076 · 8 docket documents Banner Pharmacaps Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA permit submission of an Abbreviated New Drug Application for Loperamide Hydrochloride 1 mg soft gelatin capsules, which would differ in strength and dosag	Other	2009-11-17	Granted	Banner Pharmacaps Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

35 trials from ClinicalTrials.gov, 3 active, 24 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread NCT02057133	Phase 1	Active	Eli Lilly and Company	198	2014-03-10 → 2026-12
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer NCT02747004	Phase 2	Active	Eli Lilly and Company	234	2016-09-14 → 2026-12
Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma NCT04216329	Phase 1	Active	National Cancer Institute (NCI)	11	2020-07-07 → 2028-07-30
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib NCT03094052	Phase 2	Completed	University of California, San Francisco	11	2018-10-09 → 2022-10-31
Indenoisoquinoline LMP744 in Adults With Relapsed Solid Tumors and Lymphomas NCT03030417	Phase 1	Completed	National Cancer Institute (NCI)	36	2017-02-27 → 2023-10-12
Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea NCT00685607	Phase 4	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	45	2008-10 → 2008-10
Novel Topical Therapies for the Treatment of Genital Pain NCT02099006	Phase 2/3	Completed	University of Rochester	9	2013-11 → 2015-06
Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer NCT00003057	Phase 3	Completed	Eastern Cooperative Oncology Group	500	1997-03-26
Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea NCT00292344	Phase 4	Completed	The University of Texas Health Science Center, Houston	316	2004-06 → 2005-08
Sunitinib or Cediranib for Alveolar Soft Part Sarcoma NCT01391962	Phase 2	Completed	National Cancer Institute (NCI)	34	2011-07-18 → 2026-01-16

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain6 active DMFs4 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVLOPERAMIDE HYDROCHLORIDE

DMF 73401988

PMC ISOCHEMLOPERAMIDE HYDROCHLORIDE

DMF 74531988

OLON SPALOPERAMIDE HYDROCHLORIDE

DMF 100281992

OLON SPALOPERAMIDE HYDROCHLORIDE

DMF 105171993

VASUDHA PHARMA CHEM LTDLOPERAMIDE HYDROCHLORIDE USP

DMF 277312013

VAMSI LABS LTDLOPERAMIDE HYDROCHLORIDE USP

DMF 425912025

SIFAVITOR SPAInactiveLOPERAMIDE HYDROCHLORIDE

DMF 72991988

SIPSY CHIMIE FINE SCAInactiveLOPERAMIDE HYDROCHLORIDE

DMF 80511989

LANZ LABORATORIESInactiveLOPERAMIDE HYDROCHLORIDE

DMF 83141989

JANSSEN PHARMACEUTICA NVInactiveLOPERAMIDE HYDROCHLORIDE

DMF 109421994

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 8, 2016	SUPPL -52	View Letter (PDF)
Oct 25, 2005	SUPPL -50	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.