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Generated: August 21, 2018

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MITOMYCIN - Generic Drug Details

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

Mitomycin is the generic ingredient in four branded drugs marketed by Mobius Therap, Accord Hlthcare, Hospira, Mylan Labs Ltd, West-ward Pharms Int, Supergen, Bristol, and Bristol Myers, and is included in ten NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mitomycin has nine patent family members in five countries.

There are seven drug master file entries for mitomycin. Four suppliers are listed for this compound.

Summary for MITOMYCIN
Pharmacology for MITOMYCIN
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Synonyms for MITOMYCIN
((1aS,8S,8aR,8bS)-6-amino-8a-methoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazirino[2',3':3,4]pyrrolo[1,2-a]indol-8-yl)methyl carbamate
(1ar)-6-amino-8-(((aminoc arbonyl)oxy)methyl)-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methylazirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione
(1ar)-6-amino-8-(((aminocarbonyl)oxy)methyl)-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methylazirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione
(amino-methoxy-methyl-dioxo-[?]yl)methyl carbamate
[(1aS,8S,8aR,8bS)-6-amino-8a-methoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazireno[2',3':3,4]pyrrolo[1,2-a]indol-8-yl]methyl carbamate
[(1aS,8S,8aR,8bS)-6-amino-8a-methoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazirino[2',3':3,4]pyrrolo[1,2-a]indol-8-yl]methyl carbamate
[(1aS,8S,8aR,8bS)-6-Amino-8a-methoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazirino[2'',3'':3,4]pyrrolo[1,2-a]indol-8-yl]methyl carbamate
[(4S,6S,7R,8S)-11-amino-7-methoxy-12-methyl-10,13-dioxo-2,5-diazatetracyclo[7.4.0.0;{2,7}.0;{4,6}]trideca-1(9),11-dien-8-yl]methyl carbamate
[(4S,6S,7R,8S)-11-AMINO-7-METHOXY-12-METHYL-10,13-DIOXO-2,5-DIAZATETRACYCLO[7.4.0.0(2),?.0?,?]TRIDECA-1(9),11-DIEN-8-YL]METHYL CARBAMATE
[1aR-(1aalpha,8beta,8aalpha,8balpha)]-6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methylazirino[2',3':3,4]pyrrolo[1,2-alpha]indole-4,7-dione
[1aS-(1a?,8?,8a?,8b?)]-6-Amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methylazirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione
[1aS-(1aalpha,8beta,8aalpha,8balpha)]-6-Amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methylazirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione
078M109
1404-00-8
144085-53-0
50-07-7
50SG953SK6
6-Amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a-methoxy-5-methylazirino(2',3':3,4)pyrrolo(1,2-a)indole-4,7-dione carbamate (ester)
6-amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a-methoxy-5-methylazirino[2',3':3, 4]pyrrolo[1,2-a]indole-4,7-dione, carbamate (ester)
6-amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a-methoxy-5-methylazirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, carbamate (ester)
6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl, [1aS-(1aalpha,8beta,8aalpha,8balpha)]-azirino[2',3':3,4]pyrrol o[1,2a]indole-4,7-dione
6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl, [1aS-(1aalpha,8beta,8aalpha,8balpha)]-azirino[2',3':3,4]pyrrolo[1,2a]indole-4,7-dione
7-Amino-9.alpha.-methoxymitosane
7-Amino-9&alpha
7-Amino-9alpha-methoxymitosane
74349-48-7
7481-68-7
AB00918689-03
AB00918689-04
AC1L1L1Q
AI3-26199
AKOS015895703
Ambotz50-07-7
Ametycin
AMETYCIN pound notmitomycin C
Ametycine
AN-15420
Azirino(2',3':3,4)pyrrolo(1,2-a)indole-4,7-dione, 6-amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a-methoxy-5-methyl-, carbamate (ester)
Azirino(2',3':3,4)pyrrolo(1,2-a)indole-4,7-dione, 6-amino-8-(((aminocarbonyl)oxy)methyl)-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, (1aS-(1aalpha,8beta,8aalpha,8balpha))-
Azirino(2',3':3,4)pyrrolo(1,2-a)indole-4,7-dione, 6-amino-8-(((aminocarbonyl)oxy)methyl)-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, (1aS-(1aalpha,8beta,8aalpha,8balpha))- (9CI)
Azirino(2',3':3,4)pyrrolo(1,2-a)indole-4,7-dione, 6-amino-8-(((aminocarbonyl)oxy)methyl)-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, (1aS,8S,8aR,8bS)-
Azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl -, [1aS-(1aalpha,8beta,8aalpha,8balpha)]-
Azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, (1aS,8S,8aR,8bS)-
Azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methyl-, [1aS-(1aalpha,8beta,8aalpha,8balpha)]-
Azirino[2',4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a- methoxy-5-methyl-, carbamate (ester)
Azirino[2',4]pyrrolo[1,2-a]indole-4,7-dione, 6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b- hexahydro-8a-methoxy-5-methyl-, [1aR-(1a.alpha.,8.beta.,8a.alpha.,8b.alpha.)]-
BC208285
BCP0726000181
BCP9000285
BCPP000410
BDBM50428658
Bio1_000213
Bio1_000702
Bio1_001191
Bio2_000464
Bio2_000944
BRD-K59670716-001-02-6
BSPBio_001267
C-20147
C06681
C15H18N4O5
CAS-50-07-7
CBiol_001927
CC-30970
CCG-208564
CCRIS 414
CHEBI:27504
CHEMBL105
CS-0564
D00208
D0NZ1U
D0Y0GH
DB00305
DR001605
DSSTox_CID_898
DSSTox_GSID_20898
DSSTox_RID_75853
DTXSID2020898
EINECS 200-008-6
EX-A501
GR-311
GTPL7089
HMS1362O09
HMS1792O09
HMS1990O09
HMS2089F16
HMS3403O09
HSDB 3239
HY-13316
IDI1_002219
KB-145809
KBio2_000607
KBio2_003175
KBio2_005743
KBio3_001073
KBio3_001074
KBioGR_000607
KBioSS_000607
KS-5148
LS-136
LS-173087
M2320
MFCD00078109
Mit-C
Mitamycin
Mito-C
Mitocin C
Mitocin-C
Mitomicina
Mitomicina [INN-Spanish]
Mitomycin (TN)
Mitomycin (USP/INN)
Mitomycin [USAN:INN:BAN]
mitomycin C
Mitomycin C (JP15)
Mitomycin C (JP17)
Mitomycin C from Streptomyces caespitosus
Mitomycin C from Streptomyces caespitosus, >=970 mug/mg (USP XXIV)
Mitomycin C from Streptomyces caespitosus, >=98% (HPLC), potency: >=970 mug per mg (USP XXIV), gamma-irradiated, suitable for cell culture
Mitomycin C from Streptomyces caespitosus, powder, BioReagent, suitable for cell culture
Mitomycin C from Streptomyces caespitosus, powder, contains NaCl as solubilizer
Mitomycin C, Antibiotic for Culture Media Use Only
Mitomycin C, Streptomyces caespitosus
Mitomycin C, Streptomyces caespitosus, Carrier-Free
Mitomycin-C
Mitomycine
Mitomycine [INN-French]
Mitomycins
Mitomycinum
Mitomycinum [INN-Latin]
Mitomycinum C
Mitomycyna C
Mitomycyna C [Polish]
Mitosol
Mitozytrex
Mitozytrex (TN) (Supergene)
MLS001332654
MLS002702984
MMC
MolPort-003-938-644
Muamycin
Muamycin (TN)
Mutamycin
Mytomycin
Mytozytrex
NCGC00095258-01
NCGC00163468-02
NCGC00163468-03
NCGC00163468-05
NCGC00163468-06
NCI-C04706
NSC 26980
NSC-26980
NSC26980
NWIBSHFKIJFRCO-WUDYKRTCSA-N
PL026241
Q-201410
RCRA waste no. U010
RCRA waste number U010
s8146
SC-17000
SCHEMBL3760
SMP1_000307
SMR000058401
Tox21_111493
Tox21_111493_1
UNII-50SG953SK6
UNII-V03E10691T component NWIBSHFKIJFRCO-WUDYKRTCSA-N
W-5071
WLN: T D3 B556 BN EM JV MVTTT&J GO1 H1OVZ KZ L1
ZINC30726187
ZX-AFC000411

US Patents and Regulatory Information for MITOMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd MITOMYCIN mitomycin INJECTABLE;INJECTION 202670-002 Oct 13, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bristol MUTAMYCIN mitomycin INJECTABLE;INJECTION 050450-001 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Colorcon
Medtronic
Cantor Fitzgerald
McKesson
Argus Health
Johnson and Johnson
Moodys
Merck

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