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Last Updated: June 18, 2021

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MIRTAZAPINE - Generic Drug Details

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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 Ltd, Impax Labs Inc, Zydus Pharms, Organon Usa Inc, Apotex Inc, Aurobindo, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, and Watson Labs, 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. Thirty-one suppliers are listed for this compound.

Drug Prices for MIRTAZAPINE

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Drug Sales Revenue Trends for MIRTAZAPINE

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Recent Clinical Trials for MIRTAZAPINE

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

SponsorPhase
St. Anna Ziekenhuis, Geldrop, NetherlandsN/A
Hospices Civils de LyonPhase 3
San Francisco Department of Public HealthPhase 1

See all MIRTAZAPINE clinical trials

Paragraph IV (Patent) Challenges for MIRTAZAPINE
Tradename Dosage Ingredient NDA Submissiondate
REMERON TABLET;ORAL mirtazapine 020415
REMERON SOLTAB TABLET, ORALLY DISINTEGRATING;ORAL mirtazapine 021208

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
Upsher Smith Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076219-003 Jun 19, 2003 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Apotex Inc MIRTAZAPINE mirtazapine TABLET;ORAL 077666-003 Aug 22, 2007 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Upsher Smith Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076189-001 Jun 19, 2003 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Sun Pharm Inds Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076541-001 Apr 22, 2004 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001   Try Before You Buy   Try Before You Buy
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001   Try Before You Buy   Try Before You Buy
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001   Try Before You Buy   Try Before You Buy
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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