➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Colorcon
Express Scripts
Mallinckrodt
AstraZeneca

Last Updated: May 14, 2021

DrugPatentWatch Database Preview

REMERON Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

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

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

  Get Started for $10

Drug patent expirations by year for REMERON
Drug Prices for REMERON

See drug prices for REMERON

Drug Sales Revenue Trends for REMERON

See drug sales revenues for REMERON

Recent Clinical Trials for REMERON

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

SponsorPhase
Ain Shams UniversityEarly Phase 1
Ain Shams UniversityPhase 4
University of Sao PauloPhase 3

See all REMERON clinical trials

Paragraph IV (Patent) Challenges for REMERON
Tradename Dosage Ingredient NDA Submissiondate
REMERON TABLET;ORAL mirtazapine 020415

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 Usa Inc REMERON mirtazapine TABLET;ORAL 020415-001 Jun 14, 1996 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996 AB RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001 AB RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 AB RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
>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 Usa Inc REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997   Get Started for $10   Get Started for $10
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-001 Jun 14, 1996   Get Started for $10   Get Started for $10
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Colorcon
Moodys
Boehringer Ingelheim
AstraZeneca

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.