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Mitomycin - Generic Drug Details
What are the generic drug sources for mitomycin and what is the scope of 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. Six 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: | 6 |
| Bulk Api Vendors: | 71 |
| Clinical Trials: | 206 |
| Patent Applications: | 7,325 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for mitomycin |
| DailyMed Link: | mitomycin at DailyMed |
Recent Clinical Trials for mitomycin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Chicago | Phase 2 |
| Goethe University | Phase 2 |
| ECOG-ACRIN Cancer Research Group | Phase 2 |
Pharmacology for mitomycin
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for mitomycin
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 |
| [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 |
| ACN-038344 |
| AI3-26199 |
| AKOS015895703 |
| 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 |
| BRD-K59670716-001-06-7 |
| BSPBio_001267 |
| C-20147 |
| C06681 |
| C15H18N4O5 |
| CAS-50-07-7 |
| CBiol_001927 |
| CC-30970 |
| CCG-208564 |
| CCRIS 414 |
| CHEBI:27504 |
| CHEMBL105 |
| CS-0564 |
| D00208 |
| DB00305 |
| 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 [USAN:USP:INN:BAN] |
| mitomycin C |
| 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, contains 2 mg Mitomycin C and 48 mg NaCl |
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| West-ward Pharms Int | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064117-002 | Apr 19, 1995 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Labs Ltd | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 203386-001 | Oct 13, 2017 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Bristol | MUTAMYCIN | mitomycin | INJECTABLE;INJECTION | 050450-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bristol Myers | MUTAMYCIN | mitomycin | INJECTABLE;INJECTION | 062336-003 | Mar 10, 1988 | 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 |
International Patents for mitomycin
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2008008802 | Start Trial |
| Japan | 5448071 | Start Trial |
| European Patent Office | 2046653 | Start Trial |
| Canada | 2659314 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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