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 Llc, Am Regent, Amneal, Apotex, Arthur Grp, Hospira Inc, Meitheal, Mylan Institutional, Mylan Labs Ltd, Nexus Pharms, Pharmascience Inc, and Shilpa. and is included in thirteen NDAs.
The generic ingredient in BUSULFAN is busulfan. There are ten drug master file entries for this compound. Eleven 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 AM REGENT on December 22nd, 2015.
Summary for BUSULFAN
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 573 |
| Patent Applications: | 4,670 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| TScan Therapeutics, Inc. | Phase 1 |
| Institute of Hematology and Blood Diseases Hospital | Phase 2/Phase 3 |
| Sichuan University | Phase 3 |
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Hospira Inc | BUSULFAN | busulfan | INJECTABLE;INJECTION | 205672-001 | Jul 31, 2018 | AP | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Amneal | BUSULFAN | busulfan | INJECTABLE;INJECTION | 209580-001 | Dec 18, 2017 | AP | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Pharmascience Inc | BUSULFAN | busulfan | INJECTABLE;INJECTION | 207050-001 | Mar 24, 2017 | AP | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Meitheal | BUSULFAN | busulfan | INJECTABLE;INJECTION | 212127-001 | Oct 23, 2020 | AP | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >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. |
Authorised | 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 |
