Viewing data from:

CELEXA

NDA

CITALOPRAM HYDROBROMIDE | N020822 | ABBVIE INC

4 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. 1:2013cv03288 3 patentsANDA 020822oxymorphone hydrochloride	S.D.N.Y.	2013-05-15	Terminated 2016-06-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

96 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 71 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of Intravenous (IV) Citalopram Hydrochloride During Transcranial Magnetic Stimulation in Major Depressive Disorder (MDD)NCT04846829	Early Phase 1	Active	University of California, Los Angeles	30	2017-04-24 → 2028-04-24
7T Amygdala and Citalopram Study NCT06412315	N/A	Recruiting	University of Oxford	54	2025-02-13 → 2027-04-30
Escitalopram in the Treatment of Dysthymic Disorder, Double Blind NCT00220701	Phase 4	Completed	St. Luke's-Roosevelt Hospital Center	36	2002-06 → 2009-01
Serotonin, Impulsivity, and Cocaine Dependence Treatment NCT00297505	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	120	2001-04 → 2004-11
Citalopram for Agitation in Alzheimer's Disease NCT00898807	Phase 3	Completed	JHSPH Center for Clinical Trials	186	2009-07 → 2013-09
Double-Blind Treatment of Major Depressive Disorder With Vilazodone NCT01742832	Phase 2	Completed	University of Chicago	79	2013-05 → 2016-03
Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Citalopram on Motivation NCT02113943	Phase 2	Completed	Institut National de la Santé Et de la Recherche Médicale, France	24	2014-04 → 2014-06
Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects in Fed Condition NCT00939835	Phase 1	Completed	Torrent Pharmaceuticals Limited	—	—
The Efficacy of Citalopram Treatment in Acute Stroke NCT01937182	Phase 2	Completed	University of Aarhus	642	2013-09 → 2016-12-19
A Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of JNJ-404118413 in Healthy Male Patients NCT01951053	Phase 1	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	18	2010-01 → 2010-05

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$9.47

per ea

Lowest NADAC/Unit

$9.04

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00456404001CELEXA 40 MG TABLET	$9.47	EA	Brand	$0.0416	2026-10-21
00456402001CELEXA 20 MG TABLET	$9.04	EA	Brand	$0.0303	2026-10-21

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$679.47

Highest Price

$972.40

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00456-4010-01CELEXA 10MG TABLETS	$679.47	Big4	Abbvie US LLC	07/31/2030
00456-4010-01CELEXA 10MG TABLETS	$894.03	FSS	Abbvie US LLC	07/31/2030
00456-4020-01CELEXA 20MG TABLETS	$708.20	Big4	Abbvie US LLC	07/31/2030
00456-4020-01CELEXA 20MG TABLETS	$931.84	FSS	Abbvie US LLC	07/31/2030
00456-4040-01CELEXA 40MG TABLETS	$739.03	Big4	Abbvie US LLC	07/31/2030
00456-4040-01CELEXA 40MG TABLETS	$972.40	FSS	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Celexa (2024)

Total Spending

$2.6M

Total Claims

4,196

Beneficiaries

949

Avg Cost/Unit

$9.18

Spending Trend

$3.7M(2019)→$3.5M(2020)→$3.3M(2021)→$3.1M(2022)→$2.8M(2023)→$2.6M(2024)

YoY Change:-5.7%

5yr CAGR:-0.7%

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

API Supply Chain17 active DMFs14 inactive

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

H LUNDBECK ASCITALOPRAM HYDROBROMIDE

DMF 123841997

JUBILANT BIOSYS LTDCITALOPRAM HYDROBROMIDE USP

DMF 155872001

APITORIA PHARMA PRIVATE LTDCITALOPRAM HYDROBROMIDE USP

DMF 168502003

SUN PHARMACEUTICAL INDUSTRIES LTDCITALOPRAM HYDROBROMIDE USP

DMF 170742004

NATCO PHARMA LTDCITALOPRAM HYDROBROMIDE

DMF 171852004

HETERO DRUGS LTDCITALOPRAM HYDROBROMIDE (PROCESS I)

DMF 179792005

APITORIA PHARMA PRIVATE LTDCITALOPRAM HYDROBROMIDE USP (ROUTE-1)

DMF 195882006

JUBILANT PHARMOVA LTDCITALOPRAM HYDROBROMIDE (DGR) USP

DMF 200132006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCITALOPRAM HYDROBROMIDE USP

DMF 205862007

MATRIX PHARMACORP PRIVATE LTDCITALOPRAM HYDROBROMIDE USP

DMF 211652007

DR REDDYS LABORATORIES LTDCITALOPRAM HYDROBROMIDE USP

DMF 226582009

ARCH PHARMALABS LTDCITALOPRAM HYDROBROMIDE USP (CYANO ROUTE)

DMF 235662010

WUXI JIDA PHARMACEUTICAL CO LTDCITALOPRAM HYDROBROMIDE

DMF 239792010

RAKS PHARMA PVT LTDCITALOPRAM HYDROBROMIDE, USP

DMF 250652011

HETERO DRUGS LTDCITALOPRAM HYDROBROMIDE (PROCESS II)

DMF 250882011

VIRUPAKSHA ORGANICS LTDCITALOPRAM HYDROBROMIDE

DMF 369252023

CIPLA LTDCITALOPRAM HYDROBROMIDE USP

DMF 381002023

CIPLA LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 158132002

SUMITOMO CHEMICAL CO LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 158362002

ARCH PHARMALABS LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 160452002

CIPLA LTDInactiveCITALOPRAM HYDROBROMIDE USP

DMF 165532003

FERMION OYInactiveCITALOPRAM HYDROBROMIDE

DMF 167002003

FABBRICA ITALIANA SINTETICI SPAInactiveCITALOPRAM

DMF 167172003

WOCKHARDT LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 167882003

MYLAN LABORATORIES LTDInactiveCITALOPRAM HYDROBROMIDE USP

DMF 169612003

WOCKHARDT LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 169792003

HEUMANN PHARMA GMBHInactiveCITALOPRAM HYDROBROMIDE

DMF 171042004

RANBAXY LABORATORIES LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 173342004

ESTEVE QUIMICA SAInactiveCITALOPRAM HYDROBROMIDE

DMF 175112004

JIANGSU JIWA RINTECH PHARMACEUTICAL CO LTDInactiveCITALOPRAM HYDROBROMIDE USP

DMF 200942006

IPCA LABORATORIES LTDInactiveCITALOPRAM HYDROBROMIDE USP

DMF 241212010

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

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
Apr 22, 2024	SUPPL -55	View Letter (PDF)
Aug 22, 2023	SUPPL -54	View Letter (PDF)
Feb 8, 2022	SUPPL -41	View Letter (PDF)
Sep 22, 2021	SUPPL -52	View Letter (PDF)
Jan 18, 2019	SUPPL -51	View Letter (PDF)
Jan 11, 2017	SUPPL -47	View Letter (PDF)
Jul 10, 2014	SUPPL -46	View Letter (PDF)
Apr 17, 2014	SUPPL -45	View Letter (PDF)
Dec 5, 2012	SUPPL -43	View Letter (PDF)
Mar 29, 2012	SUPPL -42	View Letter (PDF)
Aug 17, 2011	SUPPL -38	View Letter (PDF)
Aug 17, 2011	SUPPL -40	View Letter (PDF)
Feb 3, 2009	SUPPL -37	View Letter (PDF)
Sep 19, 2008	SUPPL -35	View Letter (PDF)
Aug 7, 2007	SUPPL -34	View Letter (PDF)
Feb 23, 2005	SUPPL -29	View Letter (PDF)
May 26, 2004	SUPPL -27	View Letter (PDF)
Apr 20, 2004	SUPPL -23	View Letter (PDF)
Nov 19, 2002	SUPPL -19	View Letter (PDF)
Jul 17, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 10MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 27, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 17, 1998

#003 — EQ 40MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 17, 1998

#004 — EQ 60MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 17, 1998