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Last Updated: November 22, 2024

BUSULFEX Drug Patent Profile


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Which patents cover Busulfex, and when can generic versions of Busulfex launch?

Busulfex is a drug marketed by Otsuka Pharm and is included in one NDA.

The generic ingredient in BUSULFEX 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 Busulfex

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

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Summary for BUSULFEX
Drug patent expirations by year for BUSULFEX
Drug Prices for BUSULFEX

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Recent Clinical Trials for BUSULFEX

Identify potential brand extensions & 505(b)(2) entrants

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

See all BUSULFEX clinical trials

Pharmacology for BUSULFEX
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for BUSULFEX
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 BUSULFEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm BUSULFEX busulfan INJECTABLE;INJECTION 020954-001 Feb 4, 1999 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 BUSULFEX

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

International Patents for BUSULFEX

See the table below for patents covering BUSULFEX around the world.

Country Patent Number Title Estimated Expiration
Spain 2153862 ⤷  Sign Up
Slovenia 725637 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 9508991 ⤷  Sign Up
Canada 2171738 BUSULFAN S'ADMINISTRANT PAR VOIE PARENTERALE ET UTILISE DANSLE TRAITEMENT D'INFECTIONS MALIGNES (PARENTERAL BUSULFAN FOR TREATMENT OF MALIGNANT DISEASE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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