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Last Updated: October 23, 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 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
St. Anna Ziekenhuis, Geldrop, NetherlandsN/A
Hospices Civils de LyonPhase 3
University of California, Los AngelesPhase 1

See all mirtazapine clinical trials

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

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
Aurobindo MIRTAZAPINE mirtazapine TABLET;ORAL 076921-003 Oct 22, 2004 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Elizabeth MIRTAZAPINE mirtazapine TABLET;ORAL 076241-001 Jun 25, 2003 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Elizabeth MIRTAZAPINE mirtazapine TABLET;ORAL 076308-002 Jun 20, 2003 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Labs Fl Inc MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 076307-001 Dec 17, 2003 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Elizabeth MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 076689-002 Aug 31, 2005 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 021208-003 Jan 12, 2001 ⤷  Try it Free ⤷  Try it Free
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 ⤷  Try it Free ⤷  Try it Free
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996 ⤷  Try it Free ⤷  Try it Free
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997 ⤷  Try it Free ⤷  Try it Free
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 ⤷  Try it Free ⤷  Try it Free
>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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