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Last Updated: November 19, 2019

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MIRTAZAPINE Drug Profile

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

Mirtazapine is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Impax Labs Inc, Zydus Pharms, 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 NDAs.

The generic ingredient in MIRTAZAPINE is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

Drug patent expirations by year for MIRTAZAPINE
Drug Prices for MIRTAZAPINE

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Drug Sales Revenue Trends for MIRTAZAPINE

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Recent Clinical Trials for MIRTAZAPINE

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

SponsorPhase
Montefiore Medical CenterPhase 4
Ain Shams UniversityPhase 4
Janssen-Cilag International NVPhase 3

See all MIRTAZAPINE clinical trials

Recent Litigation for MIRTAZAPINE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
Cephalon Inc. v. Barr Pharmaceuticals Inc.2008-07-22
Cephalon Inc. v. Watson Pharmaceuticals Inc.2008-06-02

See all MIRTAZAPINE litigation

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
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
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(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
AKOS005530681
AN-35645
AN-8319
ANW-42478
Avanza
Axit
Azamianserin
BBL009962
BCP14560
BCP22244
BCP9000930
BDBM50115644
BRD-A64977602-001-01-9
BRD-A64977602-001-04-3
C07570
CAS-61337-67-5
CCG-101154
CCG-220556
CHEBI:6950
CHEMBL654
CM0152
CPD000466347
CS-2398
CTK8B3409
D00563
DB00370
DSSTox_CID_3325
DSSTox_GSID_23325
DSSTox_RID_76979
DTXSID0023325
EINECS 288-060-6
EN300-49851
FT-0601544
FT-0628951
GTPL7241
HMS2052H03
HMS2233K03
HMS3268F21
HMS3370B05
HMS3374J01
HMS3394H03
HMS3657M13
HMS3713P13
HY-B0352
I01-1882
I06-0606
J10458
K532
KS-000010W5
KS-1086
L001294
LS-127703
LS-185067
M-130
M2151
MCULE-1174883554
ME-2040
Mepirzapin
Mepirzapine
Mepirzepine
methylBLAH
MFCD00865427
Mianserin, 6-Aza-; ORG 3770
Mirtabene
Mirtaz
Mirtazapin
Mirtazapina
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 solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Mirtazapine, >=98% (HPLC)
Mirtazapine, 98%
Mirtazapine, European Pharmacopoeia (EP) Reference Standard
Mirtazapine, United States Pharmacopeia (USP) Reference Standard
Mirtazapinum
Mirtazapinum [INN-Latin]
Mirtazepine
Mirtazipine
Mirtazon
MLS000759460
MLS001076676
MLS001424294
MLS006011449
MolPort-003-849-233
NC00404
NCGC00025346-01
NCGC00025346-02
NE42580
Norset
ORG 3770
Org-3770
PDSP1_001529
PDSP2_001513
Promyrtil
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
Remergon
Remeron
Remeron (TN)
Remeron SolTab
Remeron, Avanza, Zispin
Remeron;Avanza
Rexer
RONZAEMNMFQXRA-UHFFFAOYSA-N
s2016
SAM001246659
SC-16155
SCHEMBL35408
Smilon
SMR000466347
SR-01000597530
SR-01000597530-1
SR-01000597530-4
ST24048108
STK711107
SW197784-4
Tox21_110965
TR-026749
VA11306
Z2327131613
Zispin
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
Mylan Pharms Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076176-001 Jun 19, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo MIRTAZAPINE mirtazapine TABLET;ORAL 076921-002 Oct 22, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076541-002 Apr 22, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076312-001 Jun 19, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Roxane MIRTAZAPINE mirtazapine TABLET;ORAL 076270-002 Jun 19, 2003 DISCN No No   Start Trial   Start Trial   Start 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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