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Last Updated: March 28, 2024

MYLERAN Drug Patent Profile


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

Myleran is a drug marketed by Waylis Therap and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Myleran

A generic version of MYLERAN was approved as busulfan by PHARMASCIENCE INC on March 24th, 2017.

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Drug patent expirations by year for MYLERAN
Drug Prices for MYLERAN

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Recent Clinical Trials for MYLERAN

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SponsorPhase
John Horan, MDPhase 1/Phase 2
GlycoMimetics IncorporatedPhase 1/Phase 2
Baptist Health South FloridaPhase 1/Phase 2

See all MYLERAN clinical trials

Pharmacology for MYLERAN
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

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
Waylis Therap MYLERAN busulfan TABLET;ORAL 009386-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for MYLERAN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pierre Fabre Medicament Busilvex busulfan EMEA/H/C/000472
Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Withdrawn no no no 2003-07-09
Fresenius Kabi Deutschland GmbH Busulfan Fresenius Kabi busulfan EMEA/H/C/002806
Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Authorised yes no no 2014-09-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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