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Last Updated: September 26, 2022

BUSULFAN Drug Patent Profile


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When do Busulfan patents expire, and when can generic versions of Busulfan launch?

Busulfan is a drug 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, and Shilpa. and is included in thirteen NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Busulfan

A generic version of BUSULFAN was approved as busulfan by AM REGENT on December 22nd, 2015.

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Drug patent expirations by year for BUSULFAN
Drug Prices for BUSULFAN

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Recent Clinical Trials for BUSULFAN

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SponsorPhase
TScan Therapeutics, Inc.Phase 1
Institute of Hematology and Blood Diseases HospitalPhase 2/Phase 3
Sichuan UniversityPhase 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
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
Hospira Inc BUSULFAN busulfan INJECTABLE;INJECTION 205672-001 Jul 31, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal BUSULFAN busulfan INJECTABLE;INJECTION 209580-001 Dec 18, 2017 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
Meitheal BUSULFAN busulfan INJECTABLE;INJECTION 212127-001 Oct 23, 2020 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

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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