MIRTAZAPINE - Generic Drug Details

What are the generic drug sources for mirtazapine and what is the scope of freedom to operate?

Mirtazapine is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma, Impax Labs Inc, Square Pharms, Organon Usa Organon, Apotex Inc, Aurobindo, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Norvium Bioscience, Prasco, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, Watson Labs, and Organon, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for mirtazapine. Thirty-five suppliers are listed for this compound.

Summary for MIRTAZAPINE

US Patents:	0
Tradenames:	3
Applicants:	19
NDAs:	23
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	100
Patent Applications:	6,982
Drug Prices:	Drug price trends for MIRTAZAPINE
Drug Sales Revenues:	Drug sales revenues for MIRTAZAPINE
What excipients (inactive ingredients) are in MIRTAZAPINE?	MIRTAZAPINE excipients list
DailyMed Link:	MIRTAZAPINE at DailyMed

See drug prices for MIRTAZAPINE

See drug sales revenues for MIRTAZAPINE

Recent Clinical Trials for MIRTAZAPINE

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

Sponsor	Phase
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 1
Quebec Researchnetwork on aging	Phase 1
Pakistan Institute of Living and Learning	Phase 3

See all MIRTAZAPINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MIRTAZAPINE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for MIRTAZAPINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	MIRTAZAPINE	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	077376-003	Dec 8, 2005	AB	RX	No	No
Mylan	MIRTAZAPINE	mirtazapine	TABLET;ORAL	076122-003	Jun 19, 2003	AB	RX	No	No
Chartwell Rx	MIRTAZAPINE	mirtazapine	TABLET;ORAL	076219-001	Jun 19, 2003	AB	RX	No	No
Watson Labs	MIRTAZAPINE	mirtazapine	TABLET;ORAL	076312-002	Jun 19, 2003		DISCN	No	No
Norvium Bioscience	MIRTAZAPINE	mirtazapine	TABLET;ORAL	076176-001	Jun 19, 2003		DISCN	No	No
Actavis Labs Fl Inc	MIRTAZAPINE	mirtazapine	TABLET;ORAL	076336-002	Jun 20, 2003		DISCN	No	No
Actavis Labs Fl Inc	MIRTAZAPINE	mirtazapine	TABLET;ORAL	076336-001	Jun 20, 2003		DISCN	No	No

Expired US Patents for MIRTAZAPINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-002	Jan 12, 2001
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-002	Jun 14, 1996
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-001	Jun 14, 1996
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-003	Mar 17, 1997
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001

EU/EMA Drug Approvals for MIRTAZAPINE

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