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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

International Patents:	9
US Patents:	5
Tradenames:	4
Applicants:	8
NDAs:	10
Drug Master File Entries:	7
Suppliers / Packagers:	4
Bulk Api Vendors:	66
Clinical Trials:	181
Patent Applications:	7,393
Formulation / Manufacturing:	see details
DailyMed Link:	mitomycin at DailyMed

Pharmacology for mitomycin

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for mitomycin

Alkylating Agents

Antibiotics, Antineoplastic

Cross-Linking Reagents

Nucleic Acid Synthesis Inhibitors

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	202670-001	Oct 13, 2017	AP	RX	No	No
Mobius Therap	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572-001	Feb 7, 2012		RX	Yes	Yes			Y
Bristol	MUTAMYCIN	mitomycin	INJECTABLE;INJECTION	050450-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
West-ward Pharms Int	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064117-001	Apr 19, 1995	AP	RX	No	No

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International Patents for mitomycin

Country	Document Number	Estimated Expiration
Japan	5448071
Canada	2659314
European Patent Office	3175843
Japan	2009543608