➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Harvard Business School
Colorcon
McKesson
Medtronic

Last Updated: May 13, 2021

DrugPatentWatch Database Preview

Mirtazapine - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic sources for mirtazapine and what is the scope of patent protection?

Mirtazapine is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Impax Labs Inc, Zydus Pharms, Organon Usa Inc, Apotex Inc, Aurobindo, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, and Watson Labs, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for mirtazapine. Thirty suppliers are listed for this compound.

Drug Prices for mirtazapine

See drug prices for mirtazapine

Drug Sales Revenue Trends for mirtazapine

See drug sales revenues for mirtazapine

Recent Clinical Trials for mirtazapine

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

SponsorPhase
St. Anna Ziekenhuis, Geldrop, NetherlandsN/A
Hospices Civils de LyonPhase 3
San Francisco Department of Public HealthPhase 1

See all mirtazapine clinical trials

Paragraph IV (Patent) Challenges for MIRTAZAPINE
Tradename Dosage Ingredient NDA Submissiondate
REMERON TABLET;ORAL mirtazapine 020415
REMERON SOLTAB TABLET, ORALLY DISINTEGRATING;ORAL mirtazapine 021208

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
Roxane MIRTAZAPINE mirtazapine TABLET;ORAL 076270-001 Jun 19, 2003 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Sun Pharm Inds Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076541-001 Apr 22, 2004 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Actavis Elizabeth MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 076689-002 Aug 31, 2005 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Actavis Elizabeth MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 077959-002 Feb 14, 2011 DISCN No 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 mirtazapine

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

Johnson and Johnson
Merck
Moodys
AstraZeneca
McKesson
Boehringer Ingelheim

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.