REMERON Drug Patent Profile

Which patents cover Remeron, and what generic alternatives are available?

Remeron is a drug marketed by Organon and Organon Usa Organon and is included in two NDAs.

The generic ingredient in REMERON is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Remeron

A generic version of REMERON was approved as mirtazapine by TEVA on January 24^th, 2003.

Summary for REMERON

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	39
Patent Applications:	4,861
Drug Prices:	Drug price information for REMERON
What excipients (inactive ingredients) are in REMERON?	REMERON excipients list
DailyMed Link:	REMERON at DailyMed

See drug prices for REMERON

See drug sales revenues for REMERON

Recent Clinical Trials for REMERON

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2
Northwestern University	Phase 1/Phase 2
Ain Shams University	Early Phase 1

See all REMERON clinical trials

US Patents and Regulatory Information for REMERON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-001	Jun 14, 1996	AB	RX	Yes	Yes
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	AB	RX	Yes	Yes
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-002	Jun 14, 1996	AB	RX	Yes	No
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-003	Mar 17, 1997		DISCN	Yes	No
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	AB	RX	Yes	No
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-002	Jan 12, 2001	AB	RX	Yes	No

Expired US Patents for REMERON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-001	Jun 14, 1996
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-003	Mar 17, 1997
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-002	Jun 14, 1996

EU/EMA Drug Approvals for REMERON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dechra Regulatory B.V.	Mirataz	mirtazapine	EMEA/V/C/004733 For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions.	Authorised	no	no	no	2019-12-10

International Patents for REMERON

See the table below for patents covering REMERON around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	0813873
New Zealand	328113	PHARMACEUTICAL COMPOSITION COMPRISING MIRTAZAPINE AND ONE OR MORE SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRI'S)
Russian Federation	2181287	КОМБИНАЦИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И СПОСОБ ЛЕЧЕНИЯ ПАЦИЕНТОВ, СТРАДАЮЩИХ ДЕПРЕССИЕЙ (COMBINATION, PHARMACEUTICAL COMPOSITION AND METHOD OF TREATMENT OF PATIENTS SUFFERING WITH DEPRESSION)
Indonesia	17051
China	1173330
Japan	2009137970	PHARMACEUTICAL COMPOSITION COMPRISING MIRTAZAPINE AND ONE OR MORE SELECTIVE SEROTONIN REUPTAKE INHIBITOR
Mexico	9704579	COMPOSICION FARMACEUTICA QUE COMPRENDE MIRTAZAPINA Y UNO O MAS INHIBIDORES SELECTIVOS DE REABSORCION DE SEROTONINA. (PHARMACEUTICAL COMPOSITION COMPRISING MYRTAZPINE AND ONE OR MORE SEROTONINE SELECTIVE REABSORPTION INHIBITORS.)