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Last Updated: November 2, 2024

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 Organon and is included in one NDA.

The generic ingredient in REMERON SOLTAB 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 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
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Recent Clinical Trials for REMERON SOLTAB

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Teva Pharmaceuticals USAPhase 1

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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 Organon REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 AB RX Yes Yes ⤷  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
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
>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 Organon REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 ⤷  Sign Up ⤷  Sign Up
Organon Usa Organon REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 ⤷  Sign Up ⤷  Sign Up
Organon Usa Organon REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 ⤷  Sign Up ⤷  Sign Up
>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

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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.