Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKinsey
UBS
Chinese Patent Office
Federal Trade Commission
Farmers Insurance
Colorcon
Johnson and Johnson
Cantor Fitzgerald
Citi
Moodys

Generated: February 21, 2018

DrugPatentWatch Database Preview

Mirtazapine - Generic Drug Details

« Back to Dashboard

What are the generic sources for mirtazapine and what is the scope of mirtazapine freedom to operate?

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 Usa Inc, 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. Forty-eight suppliers are listed for this compound. There is one tentative approval for this compound.
Tentative approvals for MIRTAZAPINE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up15MGTABLET;ORAL
➤ Sign Up➤ Sign Up45MGTABLET;ORAL
➤ Sign Up➤ Sign Up30MGTABLET;ORAL

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
Upsher-smith Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076219-001 Jun 19, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan MIRTAZAPINE mirtazapine TABLET;ORAL 076122-001 Jun 19, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076176-001 Jun 19, 2003 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076312-002 Jun 19, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ivax Sub Teva Pharms MIRTAZAPINE mirtazapine TABLET;ORAL 076244-002 Dec 22, 2003 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 205798-003 Jun 1, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc MIRTAZAPINE mirtazapine TABLET;ORAL 077666-003 Aug 22, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076312-001 Jun 19, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Elizabeth MIRTAZAPINE mirtazapine TABLET;ORAL 076308-003 Jun 20, 2003 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076541-002 Apr 22, 2004 AB RX No 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Expired US Patents for mirtazapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 ➤ Sign Up ➤ Sign Up
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 ➤ Sign Up ➤ Sign Up
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997 ➤ Sign Up ➤ Sign Up
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001 ➤ Sign Up ➤ Sign Up
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-001 Jun 14, 1996 ➤ Sign Up ➤ Sign Up
Organon Usa Inc REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996 ➤ Sign Up ➤ Sign Up
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001 ➤ Sign Up ➤ Sign Up
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 ➤ Sign Up ➤ Sign Up
Organon Usa Inc 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Deloitte
Chubb
Express Scripts
McKinsey
Teva
Fuji
Johnson and Johnson
US Army

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 verifification 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.

botpot