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Last Updated: March 19, 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, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, 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-four 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 Pharms Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076176-001 Jun 19, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo MIRTAZAPINE mirtazapine TABLET;ORAL 076921-002 Oct 22, 2004 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane MIRTAZAPINE mirtazapine TABLET;ORAL 076270-002 Jun 19, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076189-002 Jun 19, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.