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MYLERAN Drug Profile
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» See Plans and PricingWhen do Myleran patents expire, and what generic alternatives are available?
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. Twelve 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 approved as busulfan by LUITPOLD on December 22nd, 2015.
Summary for MYLERAN
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 81 |
| Clinical Trials: | 17 |
| Patent Applications: | 4,571 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MYLERAN |
| DailyMed Link: | MYLERAN at DailyMed |
Recent Clinical Trials for MYLERAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St. Jude Children's Research Hospital | Phase 1/Phase 2 |
| Jacqueline Garcia, MD | Phase 1 |
| Fred Hutchinson Cancer Research Center | Phase 2 |
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 |
| ACMC-20aljs |
| AI3-25012 |
| AKOS003614975 |
| AN 33501 |
| BDBM50237623 |
| Bisulfex |
| BRN 1791786 |
| BSPBio_001920 |
| Busilvex |
| 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(Busulfex) |
| Busulfan/Myleran |
| Busulfano |
| Busulfano [INN-Spanish] |
| Busulfanum |
| Busulfanum [INN-Latin] |
| Busulfex |
| Busulfex IV |
| Busulphan |
| Busulphane |
| butane-1,4-diyl dimethanesulfonate |
| 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 |
| 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 |
| Myeleukon |
| Myeloleukon |
| Myelosan |
| Myelosanum |
| Mylecytan |
| 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 |
| Q348922 |
| 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 | Start Trial | Start Trial | Start Trial | |||
| Aspen Global | MYLERAN | busulfan | TABLET;ORAL | 009386-001 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | 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 |
