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CAMPRAL

NDA

ACAMPROSATE CALCIUM | N021431 | FOREST 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from RegCon Solutions FDA-2015-P-1669 · 6 docket documents RegCon Solutions filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA amend the Orange Book to designate Glenmark Generics' Acamprosate Calcium Delayed Release Tablets (ANDA 202229) as a second reference-listed drug, citing that the cur	505(q)	2015-05-13	Granted	RegCon Solutions

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

Clinical Trials

37 trials from ClinicalTrials.gov, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Biomarker Study of Acamprosate in Schizophrenia NCT00688324	Phase 4	Completed	University of Maryland, Baltimore	36	2008-06 → 2012-02
Acamprosate Treatment: Mechanisms of Action NCT00004552	Phase 2	Completed	Yale University	120	— → 2002-12
Neurophysiological and Acute Pharmacological Studies in FXS Patients NCT02998151	Early Phase 1	Completed	Children's Hospital Medical Center, Cincinnati	29	2016-01 → 2020-11
Study of Acamprosate in Fragile x Syndrome NCT01911455	Phase 1	Completed	Children's Hospital Medical Center, Cincinnati	46	2013-08-27 → 2018-11-08
Investigation of the Efficacy of Acamprosate and Calcium in Comparison to Placebo as Validation of a Behavioural Test for Alcohol Dependence NCT03634917	Phase 3	Completed	Technische Universität Dresden	82	2020-08-05 → 2024-05-01
Acamprosate Initiated During Alcohol Detoxification NCT00360594	Phase 2	Completed	Forest Laboratories	40	2006-10 → 2007-11
A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction NCT00571922	Phase 1/2	Completed	NYU Langone Health	72	2007-07 → 2008-11
Acamprosate in Youth With Fragile X Syndrome NCT01300923	Phase 2	Completed	Indiana University	14	2010-08 → 2011-09
Acamprosate in the Treatment of Binge-Eating Disorder NCT00511940	Phase 2/3	Completed	Lindner Center of HOPE	40	2007-04 → 2011-01
Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics NCT00605904	Phase 2	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	37	2008-01 → 2011-03

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

Medicare Part D Spending

CMS annual spending data for Acamprosate Calcium (2024)

Total Spending

$6.4M

Total Claims

51,736

Beneficiaries

17,386

Avg Cost/Unit

$0.76

Spending Trend

$6.1M(2019)→$6.4M(2020)→$7.0M(2021)→$7.4M(2022)→$8.1M(2023)→$6.4M(2024)

YoY Change:-19.8%

5yr CAGR:-6.0%

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

API Supply Chain6 active DMFs1 inactive

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

ANGELINI ACRAF SPAACAMPROSATE CALCIUM

DMF 213482008

SYNTHIMED LABS PRIVATE LTDACAMPROSATE CALCIUM USP

DMF 214812008

OLON SPAACAMPROSATE CALCIUM

DMF 218072008

OLON SPAACAMPROSATE CALCIUM

DMF 226252009

EMCURE PHARMACEUTICALS LTDACAMPROSATE CALCIUM USP

DMF 258092012

MICRO LABS LTDACAMPROSATE CALCIUM USP

DMF 413062025

WUHAN WUYAO PHARMACEUTICAL CO LTDInactiveACAMPROSATE CALCIUM, NON-STERILE BULK DRUG SUBSTANCE

DMF 239732010

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 1, 2012	SUPPL -15	View Letter (PDF)
Dec 15, 2010	SUPPL -13	View Letter (PDF)
Jul 30, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Jul 29, 2004

No patent or exclusivity listings for this strength.