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Last Updated: November 21, 2024

REMERON Drug Patent Profile


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

Remeron is a drug marketed by Organon and Organon Usa Organon and is included in two NDAs.

The generic ingredient in REMERON 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 Remeron

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

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Summary for REMERON
Drug patent expirations by year for REMERON
Drug Prices for REMERON

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Drug Sales Revenue Trends for REMERON

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Recent Clinical Trials for REMERON

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Northwestern UniversityPhase 1/Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 1/Phase 2
Ain Shams UniversityEarly Phase 1

See all REMERON clinical trials

US Patents and Regulatory Information for REMERON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon REMERON mirtazapine TABLET;ORAL 020415-001 Jun 14, 1996 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon Usa Organon REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon Usa Organon REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon Usa Organon REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 AB RX Yes 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

Expired US Patents for REMERON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon REMERON mirtazapine TABLET;ORAL 020415-001 Jun 14, 1996 ⤷  Sign Up ⤷  Sign Up
Organon REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997 ⤷  Sign Up ⤷  Sign Up
Organon REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for REMERON

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

International Patents for REMERON

See the table below for patents covering REMERON around the world.

Country Patent Number Title Estimated Expiration
Czech Republic 290691 Farmaceutický prostÅ™edek (Pharmaceutical preparation) ⤷  Sign Up
China 1173330 ⤷  Sign Up
Canada 2208199 COMPOSITION PHARMACEUTIQUE COMPRENANT DE LA MIRTAZAPINE ET UN INHIBITEUR SELECTIF DE LA REABSORPTION DE LA SEROTONINE OU PLUS (PHARMACEUTICAL COMPOSITION COMPRISING MIRTAZAPINE AND ONE ORMORE SELECTIVE SEROTONIN REUPTAKE INHIBITORS) ⤷  Sign Up
China 1132581 ⤷  Sign Up
Austria 213159 ⤷  Sign Up
Hungary 225534 PHARMACEUTICAL COMPOSITIONS COMPRISING MIRTAZAPINE AND ONE OR MORE SELECTIVE SEROTONIN REUPTAKE INHIBITORS ⤷  Sign Up
Australia 2612997 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.