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Mirtazapine - Generic Drug Details

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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, and Mylan Pharms Inc, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for mirtazapine. Forty-five suppliers are listed for this compound.

Summary for Generic Name: mirtazapine

Tradenames:3
Patents:0
Applicants:15
NDAs:21
Drug Master File Entries: see list17
Suppliers / Packaging: see list45
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
MIRTAZAPINE
mirtazapine
TABLET;ORAL076176-003Jun 19, 2003RXNo► subscribe► subscribe
Aurobindo Pharma Ltd
MIRTAZAPINE
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL077376-004Feb 28, 2006RXNo► subscribe► subscribe
Apotex Inc
MIRTAZAPINE
mirtazapine
TABLET;ORAL077666-001Aug 22, 2007RXNo► 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, 20015,178,878► subscribe
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-003Jan 12, 20015,178,878► subscribe
Organon Usa Inc
REMERON SOLTAB
mirtazapine
TABLET, ORALLY DISINTEGRATING;ORAL021208-002Jan 12, 20015,178,878► subscribe
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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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