Viewing data from:

REMERON

NDA

MIRTAZAPINE | N020415 | ORGANON USA LLC

3 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

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from AAC Consulting Group FDA-2002-P-0471 · 4 docket documents AAC Consulting Group filed this citizen petition on May 29, 2002, requesting that the FDA determine that 7.5 mg tablets of mirtazapine are suitable for an Abbreviated New Drug Application (ANDA) based on the listed drug Remeron 8 Tablets, 15 mg. The petitioner argued that the proposed generic produc	Other	2023-10-27	Granted	AAC Consulting Group

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

Clinical Trials

74 trials from ClinicalTrials.gov, 2 active, 47 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ NCT03935685	Phase 2	Active	University of California, Irvine	120	2019-02-26 → 2030-12-31
Effects of Mirtazapine on Appetite in Advanced Cancer Patients NCT00488072	Phase 2	Active	M.D. Anderson Cancer Center	98	2007-01-08 → 2027-12-31
New Pharmacological Treatment for Obstructive Sleep Apnea NCT00108498	Phase 1	Completed	US Department of Veterans Affairs	—	2003-10 → 2007-03
Short-term Metabolic Effects of Mirtazapine in Healthy Subjects NCT00878540	Phase 1	Completed	Max-Planck-Institute of Psychiatry	12	2008-09 → 2010-07
Pilot Study to Evaluate Individualized Choice of Antidepressants in Patients With Cancer NCT01725048	Early Phase 1	Completed	UNC Lineberger Comprehensive Cancer Center	21	2011-01 → 2013-10
Clinical Studies on the Therapeutic Effects of Mirtazapine on Drug-craving in Cocaine Addicts.NCT01949571	Phase 2	Completed	Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente	64	2007-01 → 2012-09
Treatment of Adolescent Suicide Attempters (TASA)NCT00080158	Phase 2/3	Completed	New York State Psychiatric Institute	120	2004-03 → 2007-06
Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression NCT00249444	Phase 2	Completed	New York State Psychiatric Institute	86	2006-05 → 2012-12
Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects NCT00322309	Phase 2	Completed	Boston University	24	2005-09 → 2010-02
Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors NCT00497081	Phase 2	Completed	San Francisco Department of Public Health	60	2007-05 → 2010-03

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$6.67

per ea

Lowest NADAC/Unit

$6.36

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206016101REMERON 30 MG TABLET	$6.67	EA	Brand	$0.0887	2026-01-01
78206016001REMERON 15 MG TABLET	$6.36	EA	Brand	$0.0658	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$138.83

Highest Price

$196.34

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0160-01REMERON 15MG TAB	$190.62	FSS	Organon LLC	01/14/2027
78206-0160-01REMERON 15MG TAB	$138.83	Big4	Organon LLC	01/14/2027
78206-0161-01REMERON 30MG TAB	$196.34	FSS	Organon LLC	01/14/2027
78206-0161-01REMERON 30MG TAB	$143.04	Big4	Organon LLC	01/14/2027

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

Medicare Part D Spending

CMS annual spending data for Remeron (2024)

Total Spending

$732K

Total Claims

2,169

Beneficiaries

465

Avg Cost/Unit

$5.76

Spending Trend

$137K(2021)→$756K(2022)→$791K(2023)→$732K(2024)

YoY Change:-3.3%

5yr CAGR:+3.5%

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

API Supply Chain19 active DMFs4 inactive

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

ASPEN OSS BVMIRTAZAPINE

DMF 104571993

TAPI NL BVMIRTAZAPINE

DMF 153232001

MEDICHEM SAMIRTAZAPINE

DMF 157492001

NEULAND LABORATORIES LTDMIRTAZAPINE

DMF 160072002

SUN PHARMACEUTICAL INDUSTRIES LTDMIRTAZAPINE USP [HEMIHYDRATE]

DMF 161132002

APITORIA PHARMA PRIVATE LTDMIRTAZAPINE ANHYDROUS USP

DMF 164902003

MATRIX PHARMACORP PRIVATE LTDMIRTAZAPINE USP (ANHYDROUS)

DMF 193692006

MEGAFINE PHARMA P LTDMIRTAZAPINE ANHYDROUS USP (NON-STERILE DRUG SUBSTANCE)

DMF 205702007

MEGAFINE PHARMA P LTDMIRTAZAPINE HEMIHYDRATE USP (NON STERILE DRUG SUBSTANCE)

DMF 230032009

NEULAND LABORATORIES LTDMIRTAZAPINE, USP (ANHYDROUS)

DMF 240222010

SYN-TECH CHEM AND PHARM CO LTDMIRTAZAPINE USP

DMF 297482015

NEULAND LABORATORIES LTDMIRTAZAPINE USP (ACETONE ROUTE)

DMF 308502016

MAITHRI DRUGS PRIVATE LTDMIRTAZAPINE USP [ROUTE CODE - MZ)

DMF 313222017

MAITHRI DRUGS PRIVATE LTDMIRTAZAPINE ANHYDROUS USP

DMF 370132022

HETERO DRUGS LTDMIRTAZAPINE

DMF 383412023

MICRO LABS LTDMIRTAZAPINE USP

DMF 387992023

MAHI DRUGS PRIVATE LTDMIRTAZAPINE USP

DMF 402032024

APITORIA PHARMA PRIVATE LTDMIRTAZAPINE USP (PROCESS-II)

DMF 413292025

ZHEJIANG LIAOYUAN PHARMACEUTICAL CO LTDMIRTAZAPINE

DMF 421602025

DIOSYNTH BVInactiveMIRTAZAPINE

DMF 83571989

SUMITOMO CHEMICAL CO LTDInactiveMIRTAZAPINE

DMF 153002001

ANGELINI ACRAF SPAInactiveMIRTAZAPINE

DMF 160142002

MYLAN LABORATORIES LTDInactiveMIRTAZAPINE USP (HEMIHYDRATE)

DMF 175212004

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
May 21, 2026	SUPPL -39	View Letter (PDF)
Apr 30, 2020	SUPPL -36	View Letter (PDF)
Apr 30, 2020	SUPPL -34	View Letter (PDF)
Mar 4, 2020	SUPPL -29	View Letter (PDF)
Sep 6, 2019	SUPPL -35	View Letter (PDF)
Dec 31, 2015	SUPPL -32	View Letter (PDF)
Jul 23, 2014	SUPPL -31	View Letter (PDF)
Nov 1, 2012	SUPPL -26	View Letter (PDF)
Dec 29, 2011	SUPPL -22	View Letter (PDF)
May 21, 2010	SUPPL -24	View Letter (PDF)
May 21, 2010	SUPPL -23	View Letter (PDF)
Aug 2, 2007	SUPPL -19	View Letter (PDF)
Jan 13, 2005	SUPPL -18	View Letter (PDF)
Jun 7, 2004	SUPPL -16	View Letter (PDF)
Oct 2, 2002	SUPPL -15	View Letter (PDF)
Apr 16, 2002	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 15MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 14, 1996

No patent or exclusivity listings for this strength.

#002 — 30MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 14, 1996

#003 — 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 17, 1997