You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

BUSULFEX Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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.

  Sign Up

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for BUSULFEX?
  • What are the global sales for BUSULFEX?
  • What is Average Wholesale Price for BUSULFEX?
Summary for BUSULFEX
Drug patent expirations by year for BUSULFEX
Drug Prices for BUSULFEX

See drug prices for BUSULFEX

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
Japan H09502996 ⤷  Sign Up
Portugal 725637 ⤷  Sign Up
European Patent Office 0725637 BUSULFAN S'ADMINISTRANT PAR VOIE PARENTERALE ET UTILISE DANS LE TRAITEMENT D'INFECTIONS MALIGNES (PARENTERAL BUSULFAN FOR TREATMENT OF MALIGNANT DISEASE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.