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Express Scripts
Johnson and Johnson

Last Updated: August 6, 2020

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Busulfan - Generic Drug Details

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What are the generic drug sources for busulfan and what is the scope of patent protection?

Busulfan is the generic ingredient in three branded drugs marketed by Accord Hlthcare Inc, Actavis Llc, Amneal, Apotex, Athenex Inc, Hospira Inc, Luitpold, Mylan Institutional, Mylan Labs Ltd, Nexus Pharms, Pharmascience Inc, Shilpa Medicare Ltd, Otsuka Pharm, and Aspen Global, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for busulfan. Twelve suppliers are listed for this compound.

Drug Prices for busulfan

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Recent Clinical Trials for busulfan

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Expression Therapeutics, LLCPhase 1
Baptist Health South FloridaPhase 2
Gustave Roussy, Cancer Campus, Grand ParisPhase 3

See all busulfan clinical trials

Pharmacology for busulfan
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
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
Nexus Pharms BUSULFAN busulfan INJECTABLE;INJECTION 207794-001 Jan 14, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Pharmascience Inc BUSULFAN busulfan INJECTABLE;INJECTION 207050-001 Mar 24, 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
Mylan Institutional BUSULFAN busulfan INJECTABLE;INJECTION 208536-001 Nov 20, 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:

Harvard Business School
Express Scripts

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