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Last Updated: June 6, 2020

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BUSULFAN Drug 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, 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.

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Paragraph IV (Patent) Challenges for BUSULFAN
Tradename Dosage Ingredient NDA Submissiondate
BUSULFEX INJECTABLE;INJECTION busulfan 020954 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
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

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
AstraZeneca
Dow
Express Scripts
Harvard Business School

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