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Generated: September 21, 2017

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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. Fifty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: mirtazapine

Tradenames:3
Patents:0
Applicants:16
NDAs:22
Drug Master File Entries: see list18
Suppliers / Packagers: see list50
Bulk Api Vendors: see list77
Clinical Trials: see list71
Patent Applications: see list5,061
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:mirtazapine at DailyMed

Tentative approvals for MIRTAZAPINE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe15MGTABLET;ORAL
► Subscribe► Subscribe45MGTABLET;ORAL
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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
Organon Usa Inc
REMERON
mirtazapine
TABLET;ORAL020415-001Jun 14, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
MIRTAZAPINE
mirtazapine
TABLET;ORAL076541-001Apr 22, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Upsher-smith Labs
MIRTAZAPINE
mirtazapine
TABLET;ORAL076189-003Jun 19, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
MIRTAZAPINE
mirtazapine
TABLET;ORAL077666-002Aug 22, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Upsher-smith Labs
MIRTAZAPINE
mirtazapine
TABLET;ORAL076189-001Jun 19, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
MIRTAZAPINE
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL077959-002Feb 14, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
MIRTAZAPINE
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL076307-001Dec 17, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Roxane
MIRTAZAPINE
mirtazapine
TABLET;ORAL076270-002Jun 19, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
MIRTAZAPINE
mirtazapine
TABLET;ORAL076541-003Apr 22, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo
MIRTAZAPINE
mirtazapine
TABLET;ORAL076921-001Oct 22, 2004ABRXNoNo► 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;ORAL021208-003Jan 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;ORAL021208-002Jan 12, 2001► Subscribe► Subscribe
Organon Usa Inc
REMERON
mirtazapine
TABLET;ORAL020415-002Jun 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;ORAL021208-001Jan 12, 2001► Subscribe► Subscribe
Organon Usa Inc
REMERON
mirtazapine
TABLET;ORAL020415-001Jun 14, 1996► Subscribe► Subscribe
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-003Jan 12, 2001► Subscribe► Subscribe
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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 500+ biopharmaceutical companies globally:

Express Scripts
Queensland Health
Mallinckrodt
Chubb
McKesson
Teva
Cantor Fitzgerald
Farmers Insurance
Fish and Richardson
Medtronic

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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