BUSULFAN - Generic Drug Details

What are the generic 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, Am Regent, Amneal, Apotex, Arthur Grp, Hospira, Meitheal, Mylan Institutional, Mylan Labs Ltd, Nexus, Pharmascience Inc, Shilpa, Otsuka Pharm, and Waylis Therap, 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. Thirteen suppliers are listed for this compound.

Summary for BUSULFAN

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	15
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	590
Patent Applications:	7,587
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for BUSULFAN
What excipients (inactive ingredients) are in BUSULFAN?	BUSULFAN excipients list
DailyMed Link:	BUSULFAN at DailyMed

See drug prices for BUSULFAN

Recent Clinical Trials for BUSULFAN

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

Sponsor	Phase
First Affiliated Hospital Xi'an Jiaotong University	N/A
Ossium Health, Inc.	Phase 1/Phase 2
University Hospital Inselspital, Berne	Phase 2

See all BUSULFAN clinical trials

Pharmacology for BUSULFAN

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for BUSULFAN

Alkylating Agents

Antineoplastic Agents, Alkylating

Immunosuppressive Agents

Myeloablative Agonists

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
Shilpa	BUSULFAN	busulfan	INJECTABLE;INJECTION	210931-001	Apr 18, 2019	AP	RX	No	No
Hospira	BUSULFAN	busulfan	INJECTABLE;INJECTION	205672-001	Jul 31, 2018	AP	RX	No	No
Otsuka Pharm	BUSULFEX	busulfan	INJECTABLE;INJECTION	020954-001	Feb 4, 1999	AP	RX	Yes	Yes
Actavis	BUSULFAN	busulfan	INJECTABLE;INJECTION	205139-001	Dec 8, 2017		DISCN	No	No
Amneal	BUSULFAN	busulfan	INJECTABLE;INJECTION	209580-001	Dec 18, 2017	AP	RX	No	No
Waylis Therap	MYLERAN	busulfan	TABLET;ORAL	009386-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

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
Otsuka Pharm	BUSULFEX	busulfan	INJECTABLE;INJECTION	020954-001	Feb 4, 1999

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.	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