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Last Updated: December 10, 2019

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BUSULFAN Drug Profile

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When do Busulfan patents expire, and what generic alternatives are available?

Busulfan is a drug marketed by Accord Hlthcare Inc, Actavis Llc, Amneal Pharms Co, Apotex Inc, Athenex Inc, Hospira Inc, Luitpold, Mylan Labs Ltd, Nexus Pharms, Pharmascience Inc, and Shilpa Medicare Ltd. and is included in eleven NDAs.

The generic ingredient in BUSULFAN is busulfan. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the busulfan profile page.

Drug patent expirations by year for BUSULFAN
Drug Prices for BUSULFAN

See drug prices for BUSULFAN

Recent Clinical Trials for BUSULFAN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Memorial Sloan Kettering Cancer CenterPhase 1
Bristol-Myers SquibbPhase 2
Dimitrios Tzachanis, MD PhDPhase 2

See all BUSULFAN clinical trials

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(methanesulfonyloxy)butane
1,4-Bis[methanesulfonoxy]butane
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-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-(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
ACMC-20aljs
AI3-25012
AKOS003614975
AN 33501
AN-16062
BC677894
Bisulfex
BRN 1791786
BSPBio_001920
Busulfan (JP17/USP/INN)
Busulfan (Myleran, Busulfex)
Busulfan [USP:INN:BAN:JAN]
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
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
GT 2041
GT 41
GTPL7136
HMS1920I07
HMS2091O09
HMS2233H04
HMS3259G15
HMS3370E11
HMS3655A21
HMS3712A20
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
LS-1358
Mablin
MCULE-1840882522
Methanesulfonic
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 tablets
Myleran;Busulfex
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
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-01000765405-2
SR-01000765405-3
SR-01000765405-7
ST45022142
Sulfabutin
Sulfabutin (VAN)
Sulphabutin
SW198555-3
TC-167599
Tetramethylene {bis[methanesulfonate]}
Tetramethylene bis(methanesulfonate)
Tetramethylene bis[methanesulfonate]
Tetramethylene dimethane sulfonate
Tetramethylenester kyseliny methansulfonove
Tetramethylenester kyseliny methansulfonove [Czech]
Tox21_111038
Tox21_111038_1
Tox21_201848
Tox21_300318
UNII-G1LN9045DK
WLN: WS1&O4OSW1
X 149
Z276508890
ZINC1530572
Paragraph IV (Patent) Challenges for BUSULFAN
Tradename Dosage Ingredient NDA Submissiondate
BUSULFEX INJECTABLE;INJECTION busulfan 020954 2012-12-26

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
Accord Hlthcare Inc BUSULFAN busulfan INJECTABLE;INJECTION 210148-001 Feb 22, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Luitpold BUSULFAN busulfan INJECTABLE;INJECTION 202259-001 Dec 22, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc BUSULFAN busulfan INJECTABLE;INJECTION 210448-001 May 7, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd BUSULFAN busulfan INJECTABLE;INJECTION 205184-001 Jul 13, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Actavis Llc BUSULFAN busulfan INJECTABLE;INJECTION 205139-001 Dec 8, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co BUSULFAN busulfan INJECTABLE;INJECTION 209580-001 Dec 18, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc BUSULFAN busulfan INJECTABLE;INJECTION 205672-001 Jul 31, 2018 AP RX 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

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