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Last Updated: June 14, 2021

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MIRTAZAPINE Drug Profile


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Which patents cover Mirtazapine, and what generic alternatives are available?

Mirtazapine is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Impax Labs Inc, Zydus Pharms, 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 NDAs.

The generic ingredient in MIRTAZAPINE is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mirtazapine

A generic version of MIRTAZAPINE was approved as mirtazapine by TEVA on January 24th, 2003.

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Drug patent expirations by year for MIRTAZAPINE
Drug Prices for MIRTAZAPINE

See drug prices for MIRTAZAPINE

Drug Sales Revenue Trends for MIRTAZAPINE

See drug sales revenues for MIRTAZAPINE

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
Mylan Pharms Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076176-001 Jun 19, 2003 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Aurobindo MIRTAZAPINE mirtazapine TABLET;ORAL 076921-002 Oct 22, 2004 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Sun Pharm Inds Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076541-002 Apr 22, 2004 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Watson Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076312-001 Jun 19, 2003 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Roxane MIRTAZAPINE mirtazapine TABLET;ORAL 076270-002 Jun 19, 2003 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Sun Pharm Inds Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076541-003 Apr 22, 2004 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Upsher Smith Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076219-001 Jun 19, 2003 AB RX No No   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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