BUSULFEX Drug Patent Profile

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 24^th, 2017.

Summary for BUSULFEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	140
Patent Applications:	4,668
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BUSULFEX
What excipients (inactive ingredients) are in BUSULFEX?	BUSULFEX excipients list
DailyMed Link:	BUSULFEX at DailyMed

See drug prices for BUSULFEX

Recent Clinical Trials for BUSULFEX

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

Sponsor	Phase
GlycoMimetics Incorporated	Phase 1/Phase 2
John Horan, MD	Phase 1/Phase 2
Baptist Health South Florida	Phase 2

See all BUSULFEX clinical trials

Pharmacology for BUSULFEX

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for BUSULFEX

L01AB	Alkyl sulfonates
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

Expired US Patents for BUSULFEX

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

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

International Patents for BUSULFEX

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

Country	Patent Number	Title	Estimated Expiration
Greece	3035447
South Korea	100371826
Japan	3599285