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ALBENZA

NDA

ALBENDAZOLE | N020666 | IMPAX LABORATORIES INC

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2018-P-0876 · 6 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted a petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Albendazole Tablets, 400 mg, is suitable for submission in an ANDA, referencing the approved ALBENZA Tablets	Other	2018-02-26	Granted	Hyman, Phelps & McNamara, P.C.
Amedra Pharmaceuticals LLC - Citizen Petition FDA-2013-P-0766 · 5 docket documents Amedra Pharmaceuticals LLC filed this citizen petition on June 18, 2013, requesting that the FDA refrain from approving any abbreviated new drug application for a generic version of ALBENZA (albendazole) tablets unless the applicant demonstrates bioequivalence based on systemic levels of the primary	505(q)	2013-07-16	Denied	—

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

Clinical Trials

90 trials from ClinicalTrials.gov — 1 recruiting, 72 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Oxfendazole in the Treatment of Trichuris Trichiura Infection in Adults NCT03435718	Phase 2	Not Yet Recruiting	Oxfendazole Development Group	250	2024-07 → 2026-10
Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections NCT00207753	N/A	Completed	Centers for Disease Control and Prevention	550	2005-02 → 2005-03
Effect of Albendazole Dose on Clearance of Filarial Worms NCT00339417	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	1,000	2006-02-22 → 2011-08-17
Effect of Mass Deworming on Child Growth NCT00344669	N/A	Completed	Makerere University	10,000	2000-08 → 2003-11
Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis NCT00004403	N/A	Completed	Johns Hopkins University	120	2000-05 → 2002-03
Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)NCT00441285	Phase 2/3	Completed	Universidad Peruana Cayetano Heredia	156	2010-01 → 2013-09
Triple Combinations Against Hookworm Infections in Lao NCT03278431	Phase 4	Completed	Swiss Tropical & Public Health Institute	420	2017-09-27 → 2017-12-01
Urine Albendazole Levels for Coverage Assessment NCT04041427	N/A	Completed	Universidad Nacional de Salta	12	2019-07-17 → 2020-02-28
Pharmacokinetics & Pharmacodynamics of Diethylcarbamazine (DEC)+ Albendazole (ALB) + Ivermectin (IVE)NCT02845713	Phase 1	Completed	University Hospitals Cleveland Medical Center	66	2016-04-17 → 2016-06-04
Combined Package of Interventions for Environmental Enteropathy NCT02253095	N/A	Completed	Washington University School of Medicine	253	2014-10 → 2015-04

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

Medicare Part D Spending

CMS annual spending data for Albendazole (2024)

Total Spending

$6.2M

Total Claims

12,458

Beneficiaries

8,831

Avg Cost/Unit

$31.87

Spending Trend

$6.9M(2019)→$9.9M(2020)→$8.0M(2021)→$9.7M(2022)→$10.9M(2023)→$6.2M(2024)

YoY Change:-47.1%

5yr CAGR:-29.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs3 inactive

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

UNIMARK REMEDIES LTDALBENDAZOLE USP

DMF 177542004

HOLIDAY LABS MEXICO SA DE CVALBENDAZOLE

DMF 259142012

SOLARA ACTIVE PHARMA SCIENCES LTDALBENDAZOLE

DMF 285582014

CIPLA LTDALBENDAZOLE (B) USP

DMF 309672016

MSN LIFE SCIENCES PRIVATE LTDALBENDAZOLE USP

DMF 313412017

NOVUGEN PHARMA MALAYSIA SDN BHDALBENDAZOLE USP

DMF 320132017

ZYDUS LIFESCIENCES LTDALBENDAZOLE USP

DMF 353722020

KOYE PHARMACEUTICALS PRIVATE LTDALBENDAZOLE USP

DMF 354562021

ALIVIRA ANIMAL HEALTH LTD (A GROUP CO OF SEQUENT SCIENTIFIC LTD)ALBENDAZOLE

DMF 356562021

MAHI DRUGS PRIVATE LTDALBENDAZOLE USP

DMF 383972023

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveALBENDAZOLE

DMF 61041985

CHANGZOU SYNTHETIC MATERIAL PLANTInactiveALBENDAZOLE

DMF 123081997

CIPLA LTDInactiveALBENDAZOLE USP

DMF 294932015

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jul 12, 2019	SUPPL -12	View Letter (PDF)
Oct 31, 2018	SUPPL -11	View Letter (PDF)
Dec 27, 2017	SUPPL -10	View Letter (PDF)
Jun 12, 2015	SUPPL -9	View Letter (PDF)
Nov 19, 2009	SUPPL -6	View Letter (PDF)
Nov 19, 2009	SUPPL -5	View Letter (PDF)
Aug 22, 2007	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 11, 1996

No patent or exclusivity listings for this strength.