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LEXAPRO

NDA

ESCITALOPRAM OXALATE | N021323 | ABBVIE INC

3 strengths0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

NPP

May. 12, 2026

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-4103 · 6 docket documents Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Escitalopram Oxalate Tablets, 15 mg suitable for submission as an ANDA under Section 505(j)(2)(C) of the FD&C Act. The proposed product, a new strength intermediate between the ref	Suitability	2026-04-15	Open	Lachman Consulting Services, Inc.
Suitability Petition from Newcastle Bioscience, LLC FDA-2024-P-1870 · 7 docket documents Newcastle Bioscience, LLC filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA declare Escitalopram Oxalate Orally Disintegrating Tablets in 5 mg, 10 mg, 15 mg, and 20 mg strengths suitable for submission as an ANDA, with the reference-listed drug being Lexapro Tablets 20 m	Suitability	2024-04-16	Granted	Newcastle Bioscience, LLC
Lachman Consultant Services, Inc. - Citizen Petition FDA-2007-P-0297 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting the FDA declare that Escitalopram Oxalate Orally Dissolving Film Strips in 5 mg, 10 mg, and 20 mg strengths is suitable for consideration in an abbreviated new drug application under Section 505(j)(2)(C), using Le	Other	2008-05-22	Withdrawn	—

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

Clinical Trials

12 trials from ClinicalTrials.gov, 9 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fed Condition NCT01996475	Phase 1	Completed	Torrent Pharmaceuticals Limited	—	—
Brain Imaging and Treatment Studies of the Night Eating Syndrome NCT01401595	Phase 3	Completed	University of Pennsylvania	87	2009-12 → 2011-09
A Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram in Depression NCT00866593	Phase 2/3	Completed	Shanghai Mental Health Center	260	2009-03 → 2010-03
Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial NCT01894815	Phase 3	Completed	University of Sao Paulo	245	2013-10 → 2016-11
Food Study of Escitalopram Oxalate Tablets 20 mg to Lexapro® Tablets 20 mg NCT00648661	Phase 1	Completed	Mylan Pharmaceuticals Inc	35	2004-09 → 2004-10
Treating Depression With Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS).NCT03909217	Phase 2/3	Completed	The University of Hong Kong	470	2019-07-29 → 2021-12-02
Fasting Study of Escitalopram Oxalate Tablets 20 mg and Lexapro® Tablets 20 mg NCT00648570	Phase 1	Completed	Mylan Pharmaceuticals Inc	37	2004-08 → 2004-10
Molecular Markers of Neuroplasticity During Exercise in People With Incomplete Spinal Cord Injury NCT01538693	N/A	Completed	T. George Hornby	30	2011-12 → 2015-05
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fasting Condition NCT01996462	Phase 1	Completed	Torrent Pharmaceuticals Limited	—	—
Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer NCT00387348	Phase 3	Terminated	Massachusetts General Hospital	24	2006-03 → 2011-04

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$16.13

per ea

Lowest NADAC/Unit

$14.74

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00456202001LEXAPRO 20 MG TABLET	$16.13	EA	Brand	$0.0639	2026-06-17
00456201001LEXAPRO 10 MG TABLET	$15.42	EA	Brand	$0.0394	2026-06-17
00456200501LEXAPRO 5 MG TABLET	$14.74	EA	Brand	$0.0421	2026-01-02

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

$1062.81

Highest Price

$1580.26

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00456-2005-01LEXAPRO 5MG TABLETS	$1448.42	FSS	Abbvie US LLC	07/31/2030
00456-2005-01LEXAPRO 5MG TABLETS	$1062.81	Big4	Abbvie US LLC	07/31/2030
00456-2010-01LEXAPRO 10MG TABLETS	$1514.39	FSS	Abbvie US LLC	07/31/2030
00456-2010-01LEXAPRO 10MG TABLETS	$1111.81	Big4	Abbvie US LLC	07/31/2030
00456-2020-01LEXAPRO 20MG TABLETS	$1580.26	FSS	Abbvie US LLC	07/31/2030
00456-2020-01LEXAPRO 20MG TABLETS	$1159.93	Big4	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 Lexapro (2024)

Total Spending

$17.6M

Total Claims

20,281

Beneficiaries

4,182

Avg Cost/Unit

$14.04

Spending Trend

$20.9M(2019)→$20.9M(2020)→$20.1M(2021)→$19.5M(2022)→$18.7M(2023)→$17.6M(2024)

YoY Change:-2.0%

5yr CAGR:+3.8%

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

API Supply Chain27 active DMFs8 inactive

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

H LUNDBECK ASESCITALOPRAM OXALATE

DMF 141031999

CIPLA LTDESCITALOPRAM OXALATE USP

DMF 166362003

HETERO LABS LTDESCITALOPRAM OXALATE (PROCESS-I)

DMF 179602004

ZYDUS LIFESCIENCES LTDESCITALOPRAM OXALATE USP

DMF 181192005

MATRIX PHARMACORP PRIVATE LTDESCITALOPRAM OXALATE USP

DMF 182132005

APITORIA PHARMA PRIVATE LTDESCITALOPRAM OXALATE USP

DMF 190882005

JUBILANT BIOSYS LTDESCITALOPRAM OXALATE USP

DMF 194462006

NEULAND LABORATORIES LTDESCITALOPRAM OXALATE

DMF 196622006

ARCH PHARMALABS LTDESCITALOPRAM OXALATE

DMF 196632006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDESCITALOPRAM OXALATE USP

DMF 200812006

CADILA PHARMACEUTICALS LTDESCITALOPRAM OXALATE USP

DMF 224402009

JUBILANT BIOSYS LTDESCITALOPRAM OXALATE USP (ESP PROCESS)

DMF 228642009

MACLEODS PHARMACEUTICALS LTDESCITALOPRAM OXALATE

DMF 229002009

WUXI JIDA PHARMACEUTICAL CO LTDESCITALOPRAM OXALATE

DMF 255192011

DR REDDYS LABORATORIES LTDESCITALOPRAM OXALATE (PROCESS II)

DMF 258732012

HETERO LABS LTDESCITALOPRAM OXALATE (PROCESS II)

DMF 261852012

RAKS PHARMA PVT LTDESCITALOPRAM OXALATE, USP

DMF 269672013

HEC PHARM CO LTDESCITALOPRAM OXALATE NON-STERILE BULK SUBSTANCE

DMF 284542014

MICRO LABS LTDESCITALOPRAM OXALATE USP

DMF 345682020

RUYUAN HEC PHARM CO LTDESCITALOPRAM OXALATE NON-STERILE BULK DRUG SUBSTANCE

DMF 351832020

VIRUPAKSHA ORGANICS LTDESCITALOPRAM OXALATE

DMF 366322022

CIPLA LTDESCITALOPRAM OXALATE USP (PROCESS-II)

DMF 389762023

SHODHANA LABORATORIES PRIVATE LTDESCITALOPRAM OXALATE

DMF 392002023

SMS PHARMACEUTICALS LTDESCITALOPRAM OXALATE USP

DMF 407212024

ZHEJIANG HAISEN PHARMACEUTICAL CO LTDESCITALOPRAM OXALATE

DMF 409232025

SYNERGENE ACTIVE INGREDIENTS PRIVATE LTDESCITALOPRAM OXALATE USP

DMF 410482025

MAITHRI LABORATORIES PRIVATE LTDESCITALOPRAM OXALATE USP

DMF 413152025

DR REDDYS LABORATORIES LTDInactiveESCITALOPRAM OXALATE

DMF 183422005

LUPIN LTDInactiveESCITALOPRAM OXALATE USP

DMF 191052005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveESCITALOPRAM OXALATE USP

DMF 192512006

SANDOZ PRIVATE LTDInactiveESCITALOPRAM OXALATE

DMF 227572009

CADILA HEALTHCARE LTDInactiveESCITALOPRAM OXALATE (FORM -1)

DMF 232342009

MICRO LABS LTDInactiveESCITALOPRAM OXALATE

DMF 246842010

IPCA LABORATORIES LTDInactiveESCITALOPRAM OXALATE

DMF 256602012

TOKUYAMA CORPInactiveESCITALOPRAM OXALATE

DMF 318072017

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

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
Apr 22, 2024	SUPPL -58	View Letter (PDF)
Aug 22, 2023	SUPPL -57	View Letter (PDF)
May 15, 2023	SUPPL -55	View Letter (PDF)
Sep 22, 2021	SUPPL -53	View Letter (PDF)
Sep 1, 2020	SUPPL -52	View Letter (PDF)
Jan 18, 2019	SUPPL -51	View Letter (PDF)
Jan 11, 2017	SUPPL -47	View Letter (PDF)
Nov 3, 2014	SUPPL -44	View Letter (PDF)
Jul 10, 2014	SUPPL -45	View Letter (PDF)
Dec 5, 2012	SUPPL -40	View Letter (PDF)
May 16, 2011	SUPPL -33	View Letter (PDF)
Mar 16, 2011	SUPPL -35	View Letter (PDF)
Mar 24, 2009	SUPPL -31	View Letter (PDF)
Mar 24, 2009	SUPPL -30	View Letter (PDF)
Feb 3, 2009	SUPPL -32	View Letter (PDF)
Oct 21, 2008	SUPPL -29	View Letter (PDF)
Sep 19, 2008	SUPPL -28	View Letter (PDF)
Aug 7, 2007	SUPPL -25	View Letter (PDF)
Feb 23, 2005	SUPPL -20	View Letter (PDF)
Jan 13, 2005	SUPPL -14	View Letter (PDF)
May 26, 2004	SUPPL -15	View Letter (PDF)
Dec 22, 2003	SUPPL -3	View Letter (PDF)
Dec 22, 2003	SUPPL -7	View Letter (PDF)
Aug 29, 2002	SUPPL -1	View Letter (PDF)
Aug 14, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 5MG BASE

RLDAB

0 patents1 exclusivity▴

TABLET;ORAL | Approved: Aug 14, 2002

Exclusivities (1)

Code	Date	Status
NPP	May 12, 2026	Expired

#002 — EQ 10MG BASE

RLDAB

0 patents1 exclusivity▾

TABLET;ORAL | Approved: Aug 14, 2002

#003 — EQ 20MG BASE

RLDAB

0 patents1 exclusivity▾

TABLET;ORAL | Approved: Aug 14, 2002