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Last Updated: March 28, 2024

Busulfan - Generic Drug Details


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

Busulfan is the generic ingredient in three branded drugs marketed by Accord Hlthcare Inc, Actavis, Am Regent, Amneal, Apotex, Arthur Grp, Hospira, Meitheal, Mylan Institutional, Mylan Labs Ltd, Nexus, Pharmascience Inc, Shilpa, Otsuka Pharm, and Waylis Therap, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for busulfan

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Recent Clinical Trials for busulfan

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SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Ossium Health, Inc.Phase 1/Phase 2
University Hospital Inselspital, BernePhase 2

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Pharmacology for busulfan
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for BUSULFAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BUSULFEX Injection busulfan 6 mg/mL 020954 1 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
Arthur Grp BUSULFAN busulfan INJECTABLE;INJECTION 205106-001 Sep 21, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Regent BUSULFAN busulfan INJECTABLE;INJECTION 202259-001 Dec 22, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis BUSULFAN busulfan INJECTABLE;INJECTION 205139-001 Dec 8, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex BUSULFAN busulfan INJECTABLE;INJECTION 210448-001 May 7, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal BUSULFAN busulfan INJECTABLE;INJECTION 212127-001 Oct 23, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira BUSULFAN busulfan INJECTABLE;INJECTION 205672-001 Jul 31, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal BUSULFAN busulfan INJECTABLE;INJECTION 209580-001 Dec 18, 2017 AP RX No No ⤷  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 busulfan

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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