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Generated: November 21, 2018

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Dactinomycin - Generic Drug Details

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

Dactinomycin is the generic ingredient in two branded drugs marketed by Recordati Rare, Luitpold, Mylan Labs Ltd, and West-ward Pharms Int, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for dactinomycin. Three suppliers are listed for this compound.

Pharmacology for dactinomycin
Synonyms for dactinomycin
050A760
1-N,9-N-bis[(6S,9R,10S,13R,18aS)-2,5,9-trimethyl-1,4,7,11,14-pentaoxo-6,13-bis(propan-2-yl)-hexadecahydro-1H-pyrrolo[2,1-i]1-oxa-4,7,10,13-tetraazacyclohexadecan-10-yl]-2-amino-4,6-dimethyl-3-oxo-3H-phenoxazine-1,9-dicarboxam
15160-EP2272827A1
15160-EP2275420A1
15160-EP2280012A2
15160-EP2281815A1
15160-EP2289892A1
15160-EP2292615A1
15160-EP2295055A2
15160-EP2295416A2
15160-EP2295426A1
15160-EP2295427A1
15160-EP2298748A2
15160-EP2298764A1
15160-EP2298765A1
15160-EP2301928A1
15160-EP2301933A1
15160-EP2305640A2
15160-EP2305642A2
15160-EP2305671A1
15160-EP2308833A2
15160-EP2311453A1
15160-EP2311808A1
15160-EP2311827A1
15160-EP2311829A1
15160-EP2311842A2
15160-EP2316832A1
15160-EP2316833A1
1CC1JFE158
2-Amino- 4,6-dimethyl- 3-oxo- 3H-phenoxazine- 1,9-dicarboxylic acid bis- [(5,12-diisopropyl- 9,13,16-trimethyl- 4,7,11,14,17-pentaoxo- hexadecahydro- 10-oxa- 3a,6,13,16-tetraaza- cyclopentacyclohexadecen- 8-yl)- amide]
2-amino-4,6-dimethyl-3-oxo-1-N,9-N-bis-[(18aS)-10c,14,17-trimethyl-5,8,12,15,18-pentaoxo-6c,13t-di(propan-2-yl)-18ar-hexadecahydro-1H-pyrrolo[2,1-i][1,4,7,10,13]oxatetraazacyclohexadecin-9c-yl]-3H-phenoxazine-1,9-dicarboxamid
2-amino-4,6-dimethyl-3-oxo-1-N,9-N-bis[(3R,6S,7R,10S,16S)-7,11,14-trimethyl-2,5,9,12,15-pentaoxo-3,10-di(propan-2-yl)-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]phenoxazine-1,9-dicarboxamide
2-amino-4,6-dimethyl-3-oxo-N,N'-bis[(6S,9R,10S,13R,18aS)-2,5,9-trimethyl-6,13-bis(1-methylethyl)-1,4,7,11,14-pentaoxohexadecahydro-1H-pyrrolo[2,1-i][1,4,7,10,13]oxatetraazacyclohexadecin-10-yl]-3H-phenoxazine-1,9-dicarboxamid
2-amino-4,6-dimethyl-3-oxo-N1,N9-bis[(3R,6S,7R,10S,16S)-7,11,14-trimethyl-2,5,9,12,15-pentaoxo-3,10-di(propan-2-yl)-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]phenoxazine-1,9-dicarboxamide
2-amino-N,N'-bis(hexadecahydro-2,5,9-trimethyl-6,13-bis(1-methylethyl)-1,4,7,11,14-pentaoxo-1H-pyrrolo(2,1-i)(1,4,7,10,13)oxatetra-azacyclohexadecin-10-yl)-4,6-dimethyl-3-oxo-3H-phenoxazine-1,9-dicarboxamide
2-amino-N,N''-bis[(3R,6S,7R,10S,16S)-3,10-diisopropyl-2,5,9,12,15-pentaketo-7,11,14-trimethyl-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]-3-keto-4,6-dimethyl-phenoxazine-1,9-dicarboxamide
2-amino-N,N''''-bis[(3R,6S,7R,10S,16S)-3,10-diisopropyl-2,5,9,12,15-pentaketo-7,11,14-trimethyl-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]-3-keto-4,6-dimethyl-phenoxazine-1,9-dicarboxamide
2-amino-N,N''''''''-bis[(3R,6S,7R,10S,16S)-3,10-diisopropyl-2,5,9,12,15-pentaketo-7,11,14-trimethyl-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]-3-keto-4,6-dimethyl-phenoxazine-1,9-dicarboxamide
2-amino-N1,N9-bis[(3R,6S,7R,10S,16S)-3,10-diisopropyl-7,11,14-trimethyl-2,5,9,12,15-pentaoxo-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]-4,6-dimethyl-3-oxo-phenoxazine-1,9-dicarboxamide
2-azanyl-4,6-dimethyl-3-oxidanylidene-N1,N9-bis[(3R,6S,7R,10S,16S)-7,11,14-trimethyl-2,5,9,12,15-pentakis(oxidanylidene)-3,10-di(propan-2-yl)-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]phenoxazine-1,9-dicarboxamide
3H-Phenoxazine-1,9-dicarboxamide, 2-amino-N,N'-bis(hexadecahydro-2,5,9-trimethyl-6,13-bis(1-methylethyl)-1,4,7,11,14-pentaoxo-1H-pyrrolo(2,1-i)(1,4,7,10,13)oxatetra-azacyclohexadecin-10-yl)-4,6-dimethyl-3-oxo-
50-76-0
AB00514445-05
AC1L9W52
ACT [antibiotic]
Actactinomycin A IV
ActD
Actinomycin
Actinomycin 7
Actinomycin C1
actinomycin D
Actinomycin D, for fluorescence, >=90% (HPLC), from Streptomyces sp.
Actinomycin D, from Streptomyces sp., >=95% (HPLC)
Actinomycin D, from Streptomyces sp., ~98% (HPLC)
Actinomycin D, from Streptomyces sp., suitable for cell culture, >=95%
Actinomycin IV
AI3-26374
AKOS030228553
BDBM43866
BDBM50089528
BRD-K70578146-001-01-8
CAS-50-76-0
CCG-101134
CHEBI:27666
CHEMBL1554
CHEMBL3792960
cid_457193
Cosmegen
Cosmegen Lyovac
CPD000469227
CTK8F7580
Dactinomicina
Dactinomycin [USAN:USP:INN:BAN]
Dactinomycin, United States Pharmacopeia (USP) Reference Standard
Dactinomycine
Dactinomycinum
DB00970
Dilactone actinomycindioic D acid
DSSTox_CID_31
DSSTox_GSID_20031
DSSTox_RID_75330
DTXSID9020031
DVA-DPR-SAR-MVA-(c1)DTH-PXZ-(c11)DTH-DVA-DPR-SAR-MVA
EINECS 200-063-6
FT-0080366
Glycopeptide, 4a
GNF-Pf-2290
HMS2052O17
Lyovac-Cosmegen
Meractinomycin
MFCD00005033
MLS001424196
MolPort-003-925-177
NC00384
NCGC00090796-01
NCGC00161622-01
NCGC00161622-02
NCGC00260031-01
NCGC00271789-02
NCI-C04682
NSC 3053
NSC3053
PXZ-THR-DVA-PRO-SAR-MVA-THR-DVA-PRO-SAR-MVA
RJURFGZVJUQBHK-IIXSONLDSA-N
SAM001246846
SCHEMBL3844
SMR000469227
Specific stereoisomer of N,N'-((2-amino-4,6-dimethyl-3-oxo-3H-phenoxazine-1,9-diyl)-bis(carbonylimino(2-hydroxypropylidene)carbonyliminoisobutylidenecarbonyl-1,2-pyrrolidinediylcarbonyl(methylimino)methylenecarbonyl))bis(N-me
Stereoisomer of N,N'-((2-amino-4,6-dimethyl-3-oxo-3H-phenoxazine-1,9-diyl)bis(carbonylimino(2-(1-hydroxyethyl)-1-oxo-2,1-ethanediyl)imino(2-(1-methylethyl)-1-oxo-2,1-ethanediyl)-1,2-pyrrolidinediylcarbonyl(methylimino) (1-oxo
Tox21_111997
Tox21_111997_1
Tox21_202482
UNII-0OCC969V50 component RJURFGZVJUQBHK-IIXSONLDSA-N
UNII-1CC1JFE158
UPCMLD-DP055
UPCMLD-DP055:001
UPCMLD-DP055:002

US Patents and Regulatory Information for dactinomycin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recordati Rare COSMEGEN dactinomycin INJECTABLE;INJECTION 050682-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Labs Ltd DACTINOMYCIN dactinomycin INJECTABLE;INJECTION 203385-001 Nov 9, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
West-ward Pharms Int DACTINOMYCIN dactinomycin INJECTABLE;INJECTION 090304-001 Mar 16, 2010 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Luitpold DACTINOMYCIN dactinomycin INJECTABLE;INJECTION 202562-001 Aug 23, 2013 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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:

Mallinckrodt
Covington
Chinese Patent Office
Cerilliant
Accenture
Dow
Chubb
Healthtrust
Deloitte

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