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Generated: August 17, 2018

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Mirtazapine - Generic Drug Details

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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-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Synonyms for mirtazapine
(+/-)-12-Methyl-1,2,3,4,9,13b-hexahydro-2,4a,5-triaza-tribenzo[a,c,e]cycloheptene
(1)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino(2,1-a)pyrido(2,3-c)(2)benzazepine
(14bR)-2-methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine
(N-methyl-11C)mirtazapine
1,2,3,4,10,14b-Hexahydro-2-methylpyrazino(2,1-a)pyrido(2,3-c)benzazepine
1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c](2)benzazepine
1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine
2-methyl-1,2,3,4,10,14b-hexahydrobenzo[c]pyrazino[1,2-a]pyrido[3,2-f]azepine
2-Methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine
2-methyl-1,2,3,4,9,13b-hexahydro-2,4a,5-triaza-tribenzo[a,c,e]cycloheptene
337M675
5-methyl-2,5,19-triazatetracyclo[13.4.0.0^{2,7}.0^{8,13}]nonadeca-1(15),8(13),9,11,16,18-hexaene
5-methyl-2,5,19-triazatetracyclo[13.4.0.0^{2,7}.0^{8,13}]nonadeca-1(19),8(13),9,11,15,17-hexaene
5-methyl-2,5,19-triazatetracyclo[13.4.0.0;{2,7}.0;{8,13}]nonadeca-1(19),8(13),9,11,15,17-hexaene
5-methyl-2,5,19-triazatetracyclo[13.4.0.0?,?.0?,??]nonadeca-1(19),8,10,12,15,17-hexaene
5-METHYL-2,5,19-TRIAZATETRACYCLO[13.4.0.0(2),?.0?,(1)(3)]NONADECA-1(15),8,10,12,16,18-HEXAENE
5-METHYL-2,5,19-TRIAZATETRACYCLO[13.4.0.0(2),?.0?,(1)(3)]NONADECA-1(15),8(13),9,11,16,18-HEXAENE
5-methyl-2,5,19-triazatetracyclo[13.4.0.0(2),.0,(1)(3)]nonadeca-1(19),8,10,12,15,17-hexaene
6-Azamianserin
61337-67-5
82601-27-2
85650-52-8
AB0014270
AB00698265_08
AB2000422
AC-15480
AC1L1HND
AC1Q3ZYM
ACN-S002093
Afloyan (TN)
AK162834
AK473637
AKOS005530681
Alphamirt (TN)
Alphazagen (TN)
Amirel (TN)
AN-35645
AN-8319
ANW-42478
Arintapin (TN)
Arintapina (TN)
Avanza
Avanza (TN)
Axit
Axit (TN)
Azamianserin
BBL009962
BCP9000930
BDBM50115644
Bexzis (TN)
BRD-A64977602-001-01-9
C07570
Calixta (TN)
CAS-61337-67-5
CCG-101154
CCG-220556
Celltech brand of mirtazapine
CHEBI:6950
CHEMBL654
Ciblex (TN)
CM0152
Combar (TN)
Comenter (TN)
CPD000466347
CS-2398
CTK8B3409
D00563
D05ZIK
DB00370
Divaril (TN)
DR000805
DSSTox_CID_3325
DSSTox_GSID_23325
DSSTox_RID_76979
DTXSID0023325
EINECS 288-060-6
EN300-49851
Esprital (TN)
Finmirtaza (TN)
Finpharma (TN)
Finscope (TN)
FT-0601544
FT-0628951
Genamirt (TN)
GTPL7241
Hexazipin (TN)
HMS2052H03
HMS2233K03
HMS3268F21
HMS3370B05
HMS3374J01
HMS3394H03
HMS3657M13
HY-B0352
I01-1882
I06-0606
J10458
K532
KS-000010W5
KS-1086
L001294
Loxozapin (TN)
LS-127703
LS-185067
M2151
MCULE-1174883554
ME-2040
Medizapin (TN)
Mepirzapin
Mepirzapine
Mepirzepine
methylBLAH
MFCD00865427
Miralix (TN)
Mirap (TN)
Mirazep (TN)
Miro (TN)
Miron (TN)
Mirta (TN)
Mirtabene
Mirtabene (TN)
Mirtachem (TN)
Mirtacur (TN)
Mirtadepi (TN)
Mirtagamma (TN)
Mirtal (TN)
Mirtalich (TN)
Mirtalphagen (TN)
Mirtamed (TN)
Mirtamerck (TN)
Mirtapax (TN)
Mirtapharm (TN)
Mirtapin(TN)
Mirtaratio (TN)
Mirtaril (TN)
Mirtaron (TN)
Mirtascope (TN)
Mirtasole (TN)
Mirtastad (TN)
Mirtastada (TN)
Mirtatifi (TN)
Mirtatsapiini (TN)
Mirtawin (TN)
Mirtaz
Mirtaz (TN)
Mirtazapin
Mirtazapin (TN)
Mirtazapina
Mirtazapina (TN)
Mirtazapina [INN-Spanish]
Mirtazapine (JAN/USAN/INN)
Mirtazapine (Remeron, Avanza)
Mirtazapine [USAN:BAN:INN]
Mirtazapine [USAN:INN:BAN]
Mirtazapine [USAN:USP:INN:BAN]
Mirtazapine 1.0 mg/ml in Methanol
Mirtazapine for system suitability, European Pharmacopoeia (EP) Reference Standard
Mirtazapine, >=98% (HPLC)
Mirtazapine, European Pharmacopoeia (EP) Reference Standard
Mirtazapine, United States Pharmacopeia (USP) Reference Standard
Mirtazapinum
Mirtazapinum [INN-Latin]
Mirtazelon (TN)
Mirtazen (TN)
Mirtazep (TN)
Mirtazepin (TN)
Mirtazepine
Mirtazipine
Mirtazon
Mirtazon (TN)
Mirtazza (TN)
Mirtel (TN)
Mirtoral (TN)
Mirzagen (TN)
Mirzalux (TN)
Mirzaten (TN)
Mirzaten Q-Tab (TN)
Mitrazen (TN)
Mizapin (TN)
Mizapin Sol (TN)
MLS000759460
MLS001076676
MLS001424294
MLS006011449
MolPort-003-849-233
Mundogen brand of mirtazapine
NC00404
NCGC00025346-01
NCGC00025346-02
NE42580
Norset
Norset (TN)
Noxibel (TN)
ORG 3770
Org-3770
Organon brand of mirtazapine
PDSP1_001529
PDSP2_001513
Pharmasole (TN)
Pharmazepine (TN)
PL043193
PL072102
Promyrtil
Promyrtil (TN)
PubChem22104
PYR432
Pyrazino(2,1-a)pyrido(2,3-c)(2)benzazepine, 1,2,3,4,10,14b-hexahydro-2-methyl-
Pyrazino[2,1-a]pyrido[2,3-c][2]benzazepine, 1,2,3,4,10,14b-hexahydro-2-methyl-
Pyrazino[2,1-a]pyrido[2,3-c][2]benzazepine, 1,2,3,4,10,14b-hexahydro-2-methyl- 85650-52-8
Pyrazino[2,1-a]pyrido[2,3-c][2]benzazepine, 1,2,3,4,10,14b-hexahydro-2-methyl-, (.+/-.)-
Reflex (TN)
Remergil
Remergil (TN)
Remergon
Remergon (TN)
Remeron
Remeron (TN)
Remeron SolTab
Remeron SolTab (TN)
Remeron, Avanza, Zispin
Remeron;Avanza
Remirta (TN)
Rexer
Rexer (TN)
RONZAEMNMFQXRA-UHFFFAOYSA-N
s2016
SAM001246659
SC-16155
SCHEMBL35408
SMR000466347
SolTab (TN)
ST24048108
STK711107
Tarzapine (TN)
Tazamel (TN)
Tazapin (TN)
Tazascope (TN)
Tirzamed (TN)
Tox21_110965
TR-026749
VA11306
Valdren (TN)
Vastat (TN)
Z2327131613
Zapex (TN)
Zicomber (TN)
Zismirt (TN)
Zispin
Zispin (TN)
Zispin SolTab (TN)
Zistap. (TN)
Zuleptan (TN)
Tentative approvals for MIRTAZAPINE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial15MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial45MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial30MGTABLET;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
Actavis Labs Fl Inc MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 076307-003 Feb 28, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Elizabeth MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 077959-003 Feb 14, 2011 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Elizabeth MIRTAZAPINE mirtazapine TABLET;ORAL 076241-001 Jun 25, 2003 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Colorcon
UBS
US Army
Federal Trade Commission
Cantor Fitzgerald
Healthtrust
Medtronic
McKesson

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.