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Daiichi Sankyo
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Generated: November 13, 2018

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Busulfan - Generic Drug Details

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

Busulfan is the generic ingredient in three branded drugs marketed by Actavis Llc, Amneal Pharms Co, Hospira Inc, Luitpold, Mylan Labs Ltd, Pharmascience Inc, Sandoz Inc, Otsuka Pharm, Aspen Global Inc, and Aspen Global, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for busulfan. Eight suppliers are listed for this compound.

Pharmacology for busulfan
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Synonyms for busulfan
1, {4-Bis[methanesulfonoxy]butane}
1,{4-Bis[methanesulfonoxy]butane}
1,4-Bis(methanesulfonoxy)butane
1,4-Bis(methanesulfonyloxy)butane
1,4-Bis[methanesulfonoxy]butane
1,4-Butanedi yl dimethanesulfonate
1,4-BUTANEDIOL DIMETHANESULFONATE
1,4-Butanediol dimethanesulphonate
1,4-Butanediol dimethylsulfonate
1,4-Butanediol, dimethanesulfonate
1,4-Butanediol, dimethanesulphonate
1,4-butanedioldimethanesulfonate
1,4-Butanediyl dimethanesulfonate
1,4-Di(methylsulfonoxy)butane
1,4-Dimesyloxybutane
1,4-Dimethane sulfonyl oxybutane
1,4-Dimethanesulfonoxybutane
1,4-Dimethanesulfonoxylbutane
1,4-Dimethanesulfonyloxybutane
1,4-Dimethanesulphonyloxybutane
1,4-Dimethylsulfonoxybutane
1,4-Dimethylsulfonyloxybutane
15167-EP2272827A1
15167-EP2272832A1
15167-EP2275420A1
15167-EP2295055A2
15167-EP2295416A2
15167-EP2295426A1
15167-EP2295427A1
15167-EP2298748A2
15167-EP2298764A1
15167-EP2298765A1
15167-EP2298778A1
15167-EP2305642A2
15167-EP2308833A2
15167-EP2308861A1
15167-EP2311453A1
15167-EP2311825A1
15167-EP2311842A2
15167-EP2316832A1
15167-EP2316833A1
2041 C. B
2041 C. B.
2041 C.B
2041 C.B.
2041CB
32314-EP2280012A2
32314-EP2281815A1
32314-EP2292595A1
32314-EP2292615A1
32314-EP2301928A1
32314-EP2301933A1
32314-EP2305640A2
32314-EP2305671A1
32314-EP2311827A1
32314-EP2311840A1
4-((Methylsulfonyl)oxy)butyl methanesulfonate
4-(methanesulfonyloxy)butyl methanesulfonate
4-(methylsulfonyloxy)butyl methylsulfonate
4-[(Methylsulfonyl)oxy]butyl methanesulfonate #
4-methylsulfonyloxybutyl methanesulfonate
55-98-1
AB00051929_12
AB00051929_14
AB00051929-10
AB00051929-11
AB0006846
AB2000224
AC-198
AC1L1DRQ
AC1Q4GRQ
acid, tetramethylene ester
ACMC-20aljs
AI3-25012
AK307420
AKOS003614975
alkylating agent: crosslinks guanine residues
Ambap55-98-1
AN 33501
AN-16062
BC677894
Bisulfex
BRN 1791786
BSPBio_001920
Busilvex
BUSULFAN (1,4-BUTANEDIOL, DIMETHANESULFONATE)
Busulfan (JP17/USP/INN)
Busulfan (Myleran, Busulfex)
Busulfan [INN:JAN]
Busulfan [USP:INN:BAN:JAN]
Busulfan, 98% 5g
Busulfan, analytical standard, for drug analysis
Busulfan, European Pharmacopoeia (EP) Reference Standard
Busulfan;
Busulfan/Myleran
Busulfano
Busulfano [INN-Spanish]
Busulfanum
Busulfanum [INN-Latin]
Busulfex
Busulfex IV
Busulphan
Busulphane
butane-1,4-diyl dimethanesulfonate
Butanedioldimethanesulfonate
Buzulfan
C.B. 2041
C06862
C6H14O6S2
CAS-55-98-1
CB 2041
CCG-35458
CCRIS 418
CHEBI:28901
CHEMBL820
Citosulfan
COVZYZSDYWQREU-UHFFFAOYSA-
COVZYZSDYWQREU-UHFFFAOYSA-N
CPD000058613
CS-2224
CTK1G9627
D00248
D07SUG
DB01008
DivK1c_000847
DSSTox_CID_910
DSSTox_GSID_20910
DSSTox_RID_75857
DTXSID3020910
EINECS 200-250-2
FT-0083567
FT-0623291
G.T. 41
G1LN9045DK
Glyzophrol
GT 2041
GT 41
GTPL7136
HMS1920I07
HMS2091O09
HMS2233H04
HMS3259G15
HMS3370E11
HMS3655A21
HMS502K09
HSDB 7605
HY-B0245
I09-1371
IDI1_000847
InChI=1/C6H14O6S2/c1-13(7,8)11-5-3-4-6-12-14(2,9)10/h3-6H2,1-2H3
K-9954
KBio1_000847
KBio2_000512
KBio2_003080
KBio2_005648
KBio3_001420
KBioGR_000698
KBioSS_000512
KS-000012XA
KS-5212
Leucosulfan
LP056981
LS-1358
Mablin
MCULE-1840882522
Methanesulfonic
Methanesulfonic acid, tetram ethylene ester
Methanesulfonic acid, tetramethylene ester
MFCD00007562
Mielevcin
Mielosan
Mielucin
Milecitan
Mileran
Misulban
Mitosan
Mitostan
MLS001076666
MolPort-001-783-406
Myeleukon
Myeloleukon
Myelosan
Myelosanum
Mylecytan
Myleran
MYLERAN (TN)
Myleran tablets
Myleran, Busulfex, Busulfan
Myleran;Busulfex
Mylerlan
n-Butane-1,3-di(methylsulfonate)
NC00498
NCGC00090905-01
NCGC00090905-02
NCGC00090905-03
NCGC00090905-04
NCGC00090905-05
NCGC00090905-06
NCGC00090905-07
NCGC00090905-08
NCGC00090905-09
NCGC00090905-10
NCGC00090905-11
NCGC00090905-12
NCGC00254038-01
NCGC00259397-01
NCI-C01592
NCI60_041640
NCIMech_000192
NINDS_000847
NSC 750
NSC-750
NSC-755916
NSC750
NSC755916
O994
OR011696
OR285011
OR285012
Pharmakon1600-01500152
Prestwick_989
s1692
SAM002554887
SBI-0051300.P003
SC-22586
SCHEMBL4373
SMR000058613
SPBio_000253
Spectrum_000092
SPECTRUM1500152
Spectrum2_000067
Spectrum3_000320
Spectrum4_000259
Spectrum5_000928
SR-01000765405
SR-01000765405-7
ST45022142
ST50825921
Sulfabutin
Sulfabutin (VAN)
Sulphabutin
TC-167599
Tetramethylene {bis[methanesulfonate]}
Tetramethylene bis(methanesulfonate)
Tetramethylene bis[methanesulfonate]
Tetramethylene dimethane sulfonate
Tetramethylenester kyseliny methansulfonove
Tetramethylenester kyseliny methansulfonove [Czech]
Tetramethylenester kyseliny methansulfonove[Czech]
Tox21_111038
Tox21_111038_1
Tox21_201848
Tox21_300318
UNII-G1LN9045DK
WLN: WS1&O4OSW1
X 149
Z276508890
ZINC1530572

US Patents and Regulatory Information for busulfan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aspen Global MYLERAN busulfan TABLET;ORAL 009386-001 Approved Prior to Jan 1, 1982 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aspen Global Inc MYLERAN busulfan INJECTABLE;INJECTION 208536-001 Nov 20, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Llc BUSULFAN busulfan INJECTABLE;INJECTION 205139-001 Dec 8, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Luitpold BUSULFAN busulfan INJECTABLE;INJECTION 202259-001 Dec 22, 2015 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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Expired US Patents for busulfan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm BUSULFEX busulfan INJECTABLE;INJECTION 020954-001 Feb 4, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka Pharm BUSULFEX busulfan INJECTABLE;INJECTION 020954-001 Feb 4, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fuji
UBS
Queensland Health
Cipla
Argus Health
Mallinckrodt
Dow
Merck

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