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MYLERAN Drug Profile

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Which patents cover Myleran, and when can generic versions of Myleran launch?

Myleran is a drug marketed by Mylan Institutional and Aspen Global and is included in two NDAs.

The generic ingredient in MYLERAN 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.

US ANDA Litigation and Generic Entry Outlook for Myleran

A generic version of MYLERAN was launched as busulfan by LUITPOLD on December 13^th, 2019.

Summary for MYLERAN

US Patents:	0
Applicants:	2
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	81
Clinical Trials:	16
Patent Applications:	7,963
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MYLERAN
DailyMed Link:	MYLERAN at DailyMed

See drug prices for MYLERAN

Recent Clinical Trials for MYLERAN

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

Sponsor	Phase
Jacqueline Garcia, MD	Phase 1
Fred Hutchinson Cancer Research Center	Phase 2
St. Jude Children's Research Hospital	Phase 1/Phase 2

See all MYLERAN clinical trials

Pharmacology for MYLERAN

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Synonyms for MYLERAN

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

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 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

US Patents and Regulatory Information for MYLERAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	MYLERAN	busulfan	INJECTABLE;INJECTION	208536-001	Nov 20, 2017	AP	RX	No	No
Aspen Global	MYLERAN	busulfan	TABLET;ORAL	009386-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes