Mirtazapine - Generic Drug Details

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What are the generic sources for mirtazapine and what is the scope of patent protection?

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-four 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:	34
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

Drug Sales Revenue Trends for mirtazapine

See drug sales revenues for mirtazapine

Recent Clinical Trials for mirtazapine

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

Sponsor	Phase
Quebec Researchnetwork on aging	Phase 1
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 1
University of Toronto	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs Inc	MIRTAZAPINE	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	076901-002	Jun 28, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Square Pharms	MIRTAZAPINE	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	205798-001	Jun 1, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Inc	MIRTAZAPINE	mirtazapine	TABLET;ORAL	077666-003	Aug 22, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo	MIRTAZAPINE	mirtazapine	TABLET;ORAL	076921-004	Oct 22, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for mirtazapine

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

EU/EMA Drug Approvals for mirtazapine

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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