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Last Updated: October 29, 2020

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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 patent protection?

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 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
Ain Shams UniversityEarly Phase 1
Montefiore Medical CenterPhase 4
Ain Shams UniversityPhase 4

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 076189-002 Jun 19, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 076307-002 Dec 17, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan MIRTAZAPINE mirtazapine TABLET;ORAL 076122-002 Jun 19, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
>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 021208-002 Jan 12, 2001   Start Trial   Start Trial
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001   Start Trial   Start Trial
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996   Start Trial   Start Trial
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Moodys
Merck
AstraZeneca
Colorcon

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