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Last Updated: November 24, 2024

MIRTAZAPINE Drug Patent 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, Impax Labs Inc, Square Pharms, Apotex Inc, Aurobindo, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Norvium Bioscience, Prasco, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, and Watson Labs. and is included in twenty-one NDAs.

The generic ingredient in MIRTAZAPINE is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-five 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

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Drug Sales Revenue Trends for MIRTAZAPINE

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Recent Clinical Trials for MIRTAZAPINE

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SponsorPhase
Quebec Researchnetwork on agingPhase 1
Centre hospitalier de l'Université de Montréal (CHUM)Phase 1
Pakistan Institute of Living and LearningPhase 3

See all MIRTAZAPINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MIRTAZAPINE

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 MIRTAZAPINE mirtazapine TABLET;ORAL 076122-001 Jun 19, 2003 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo MIRTAZAPINE mirtazapine TABLET;ORAL 076921-002 Oct 22, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prasco MIRTAZAPINE mirtazapine TABLET;ORAL 216751-003 Jan 18, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva MIRTAZAPINE mirtazapine TABLET;ORAL 076119-003 Jun 19, 2003 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience MIRTAZAPINE mirtazapine TABLET;ORAL 076176-002 Jun 19, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for MIRTAZAPINE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Dechra Regulatory B.V. Mirataz mirtazapine EMEA/V/C/004733
For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions.
Authorised no no no 2019-12-10
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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