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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Questions you can ask:
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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: | 4,632 |
Drug Prices: | Drug price information for BUSULFEX |
What excipients (inactive ingredients) are in BUSULFEX? | BUSULFEX excipients list |
DailyMed Link: | BUSULFEX at DailyMed |
Recent Clinical Trials for BUSULFEX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
John Horan, MD | Phase 1/Phase 2 |
GlycoMimetics Incorporated | Phase 1/Phase 2 |
Baptist Health South Florida | Phase 2 |
Pharmacology for BUSULFEX
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka Pharm | BUSULFEX | busulfan | INJECTABLE;INJECTION | 020954-001 | Feb 4, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |