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Serving leading biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
Covington
McKinsey
Mallinckrodt
AstraZeneca
Johnson and Johnson
US Department of Justice
Cerilliant
Queensland Health

Generated: November 21, 2017

DrugPatentWatch Database Preview

Mirtazapine - Generic Drug Details

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

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

There are eighteen drug master file entries for mirtazapine. Forty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Tentative approvals for MIRTAZAPINE

Applicant Application No. Strength Dosage Form
u► Subscribe15MGTABLET;ORAL
u► Subscribe45MGTABLET;ORAL
u► Subscribe30MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
MIRTAZAPINE
mirtazapine
TABLET;ORAL076119-002Jan 24, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
MIRTAZAPINE
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL077959-001Feb 14, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
MIRTAZAPINE
mirtazapine
TABLET;ORAL076122-002Jun 19, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Upsher-smith Labs
MIRTAZAPINE
mirtazapine
TABLET;ORAL076189-002Jun 19, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa Inc
MIRTAZAPINE
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL205798-002Jun 1, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
MIRTAZAPINE
mirtazapine
TABLET;ORAL076176-002Jun 19, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
MIRTAZAPINE
mirtazapine
TABLET;ORAL076336-002Jun 20, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
MIRTAZAPINE
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL077376-003Dec 8, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
MIRTAZAPINE
mirtazapine
TABLET;ORAL076541-002Apr 22, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
MIRTAZAPINE
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL077376-002Dec 8, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: mirtazapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-001Jan 12, 2001► Subscribe► Subscribe
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-002Jan 12, 2001► Subscribe► Subscribe
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-003Jan 12, 2001► Subscribe► Subscribe
Organon Usa Inc
REMERON
mirtazapine
TABLET;ORAL020415-002Jun 14, 1996► Subscribe► Subscribe
Organon Usa Inc
REMERON
mirtazapine
TABLET;ORAL020415-001Jun 14, 1996► Subscribe► Subscribe
Organon Usa Inc
REMERON
mirtazapine
TABLET;ORAL020415-003Mar 17, 1997► Subscribe► Subscribe
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-003Jan 12, 2001► Subscribe► Subscribe
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-002Jan 12, 2001► Subscribe► Subscribe
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-001Jan 12, 2001► Subscribe► Subscribe
This preview shows a limited data set
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Export unavailable in trial.
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Colorcon
US Army
Harvard Business School
Chubb
US Department of Justice
Covington
Queensland Health
McKinsey
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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