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Last Updated: June 25, 2022

REMERON SOLTAB Drug Patent Profile


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When do Remeron Soltab patents expire, and when can generic versions of Remeron Soltab launch?

Remeron Soltab is a drug marketed by Organon Usa Inc and is included in one NDA.

The generic ingredient in REMERON SOLTAB is mirtazapine. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Remeron Soltab

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

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

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Recent Clinical Trials for REMERON SOLTAB

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SponsorPhase
Teva Pharmaceuticals USAPhase 1

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Anatomical Therapeutic Chemical (ATC) Classes for REMERON SOLTAB

US Patents and Regulatory Information for REMERON SOLTAB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 SOLTAB

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 See Plans and Pricing See Plans and Pricing
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001 See Plans and Pricing See Plans and Pricing
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 See Plans and Pricing See Plans and Pricing
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001 See Plans and Pricing See Plans and Pricing
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 See Plans and Pricing See Plans and Pricing
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for REMERON SOLTAB

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 SOLTAB

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

Country Patent Number Title Estimated Expiration
Norway 313177 See Plans and Pricing
Japan H05500956 See Plans and Pricing
Indonesia 17051 See Plans and Pricing
Argentina 007609 UNA COMPOSICION FARMACEUTICA See Plans and Pricing
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) See Plans and Pricing
South Africa 9705335 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
McKesson
Moodys
Mallinckrodt
Dow

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