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LOPERAMIDE HYDROCHLORIDE

NDA

LOPERAMIDE HYDROCHLORIDE | N021855 | BIONPHARMA INC

2 strengths0 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

No FDA citizen petitions matched from Regulations.gov

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs

Highest NADAC/Unit

$0.1334

per ea

Lowest NADAC/Unit

$0.1334

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70000046101ANTI-DIARRHEAL 2 MG SOFTGEL	$0.1334	EA	Generic	—	2026-06-17
83324020924QC ANTI-DIARRHEAL 2 MG SOFTGEL	$0.1334	EA	Generic	—	2026-06-17
83324020812QC ANTI-DIARRHEAL 2 MG SOFTGEL	$0.1334	EA	Generic	—	2026-06-17
70677106201FT ANTI-DIARRHEAL 2 MG SOFTGEL	$0.1334	EA	Generic	—	2026-06-17
46122058162ANTI-DIARRHEAL 2 MG SOFTGEL	$0.1334	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

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

4 letters from Drugs@FDA

Date	Submission	Document
Jun 24, 2020	SUPPL -14	View Letter (PDF)
Jul 15, 2019	SUPPL -9	View Letter (PDF)
Mar 14, 2017	SUPPL -6	View Letter (PDF)
Aug 8, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 4, 2005

No patent or exclusivity listings for this strength.

#002 — 2MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 4, 2005