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Last Updated: September 26, 2022

Busulfan - Generic Drug Details


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What are the generic drug sources for busulfan and what is the scope of patent protection?

Busulfan is the generic ingredient in three branded drugs marketed by Accord Hlthcare Inc, Actavis Llc, Am Regent, Amneal, Apotex, Arthur Grp, Hospira Inc, Meitheal, Mylan Institutional, Mylan Labs Ltd, Nexus Pharms, Pharmascience Inc, Shilpa, Otsuka Pharm, and Woodward Specl, 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. Eleven suppliers are listed for this compound.

Drug Prices for busulfan

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Recent Clinical Trials for busulfan

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SponsorPhase
Institute of Hematology and Blood Diseases HospitalPhase 2/Phase 3
Sichuan UniversityPhase 3
First People's Hospital of ChenzhouPhase 2/Phase 3

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Pharmacology for busulfan
Drug Class Alkylating 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 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pharmascience Inc BUSULFAN busulfan INJECTABLE;INJECTION 207050-001 Mar 24, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Labs Ltd BUSULFAN busulfan INJECTABLE;INJECTION 205184-001 Jul 13, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex BUSULFAN busulfan INJECTABLE;INJECTION 210448-001 May 7, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare Inc BUSULFAN busulfan INJECTABLE;INJECTION 210148-001 Feb 22, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Institutional BUSULFAN busulfan INJECTABLE;INJECTION 208536-001 Nov 20, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Shilpa BUSULFAN busulfan INJECTABLE;INJECTION 210931-001 Apr 18, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for busulfan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm BUSULFEX busulfan INJECTABLE;INJECTION 020954-001 Feb 4, 1999 See Plans and Pricing See Plans and Pricing
Otsuka Pharm BUSULFEX busulfan INJECTABLE;INJECTION 020954-001 Feb 4, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.
Authorised 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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