Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Harvard Business School
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Mallinckrodt

Last Updated: November 21, 2019

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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 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, 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-eight suppliers are listed for this compound.

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
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 AB RX Yes No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076176-002 Jun 19, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc MIRTAZAPINE mirtazapine TABLET;ORAL 076336-003 Jun 20, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076312-002 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

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

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Serving leading biopharmaceutical companies globally:

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