BUSULFAN Drug Patent Profile
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When do Busulfan patents expire, and when can generic versions of Busulfan launch?
Busulfan is a drug marketed by Accord Hlthcare Inc, Actavis, Am Regent, Amneal, Apotex, Arthur Grp, Eugia Pharma, Hospira, Meitheal, Mylan Institutional, Nexus, Norvium Bioscience, Pharmascience Inc, Prinston Inc, and Shilpa. and is included in fifteen NDAs.
The generic ingredient in BUSULFAN 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 Busulfan
A generic version of BUSULFAN was approved as busulfan by PHARMASCIENCE INC on March 24th, 2017.
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Summary for BUSULFAN
| US Patents: | 0 |
| Applicants: | 15 |
| NDAs: | 15 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 106 |
| Clinical Trials: | 597 |
| Patent Applications: | 4,620 |
| Drug Prices: | Drug price information for BUSULFAN |
| DailyMed Link: | BUSULFAN at DailyMed |
Recent Clinical Trials for BUSULFAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rising Tide Foundation | Phase 1/Phase 2 |
| The Leukemia and Lymphoma Society | Phase 1/Phase 2 |
| St. Louis Children's Hospital Foundation | Phase 1/Phase 2 |
Pharmacology for BUSULFAN
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for BUSULFAN
Anatomical Therapeutic Chemical (ATC) Classes for BUSULFAN
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare Inc | BUSULFAN | busulfan | INJECTABLE;INJECTION | 210148-001 | Feb 22, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | BUSULFAN | busulfan | INJECTABLE;INJECTION | 215102-001 | Jun 25, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal | BUSULFAN | busulfan | INJECTABLE;INJECTION | 209580-001 | Dec 18, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Norvium Bioscience | BUSULFAN | busulfan | INJECTABLE;INJECTION | 205184-001 | Jul 13, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | BUSULFAN | busulfan | INJECTABLE;INJECTION | 205672-001 | Jul 31, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Prinston Inc | BUSULFAN | busulfan | INJECTABLE;INJECTION | 215235-001 | Sep 11, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis | BUSULFAN | busulfan | INJECTABLE;INJECTION | 205139-001 | Dec 8, 2017 | DISCN | No | No | ⤷ 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 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
