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BUSULFAN Drug Profile
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» See Plans and PricingWhen do Busulfan patents expire, and when can generic versions of Busulfan launch?
Busulfan is a drug marketed by Accord Hlthcare Inc, Actavis Llc, Amneal, Apotex, Athenex Inc, Hospira Inc, Luitpold, Mylan Institutional, Mylan Labs Ltd, Nexus Pharms, Pharmascience Inc, and Shilpa Medicare Ltd. and is included in twelve NDAs.
The generic ingredient in BUSULFAN is busulfan. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the busulfan profile page.
US ANDA Litigation and Generic Entry Outlook for Busulfan
A generic version of BUSULFAN was approved as busulfan by LUITPOLD on December 22nd, 2015.
Summary for BUSULFAN
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 12 |
| Suppliers / Packagers: | 11 |
| Bulk Api Vendors: | 81 |
| Clinical Trials: | 481 |
| Patent Applications: | 4,547 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BUSULFAN |
| DailyMed Link: | BUSULFAN at DailyMed |
Pharmacology for BUSULFAN
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories 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 | Start Trial | Start Trial | Start Trial | |||
| Luitpold | BUSULFAN | busulfan | INJECTABLE;INJECTION | 202259-001 | Dec 22, 2015 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Apotex | BUSULFAN | busulfan | INJECTABLE;INJECTION | 210448-001 | May 7, 2019 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Shilpa Medicare Ltd | BUSULFAN | busulfan | INJECTABLE;INJECTION | 210931-001 | Apr 18, 2019 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Institutional | BUSULFAN | busulfan | INJECTABLE;INJECTION | 208536-001 | Nov 20, 2017 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Actavis Llc | BUSULFAN | busulfan | INJECTABLE;INJECTION | 205139-001 | Dec 8, 2017 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amneal | BUSULFAN | busulfan | INJECTABLE;INJECTION | 209580-001 | Dec 18, 2017 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
