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Serving leading biopharmaceutical companies globally:

Cipla
Johnson and Johnson
Express Scripts
Accenture
Baxter
Daiichi Sankyo
Teva
Chinese Patent Office
Queensland Health
Deloitte

Generated: February 21, 2018

DrugPatentWatch Database Preview

Busulfan - Generic Drug Details

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What are the generic sources for busulfan and what is the scope of busulfan freedom to operate?

Busulfan
is the generic ingredient in three branded drugs marketed by Actavis Llc, Amneal Pharms Co, Luitpold Pharms Inc, Pharmascience Inc, Sandoz Inc, Otsuka Pharm, Aspen Global Inc, and Aspen Global, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for busulfan. Eight suppliers are listed for this compound.
Pharmacology for busulfan
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

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
Pharmascience Inc BUSULFAN busulfan INJECTABLE;INJECTION 207050-001 Mar 24, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Luitpold Pharms Inc BUSULFAN busulfan INJECTABLE;INJECTION 202259-001 Dec 22, 2015 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Otsuka Pharm BUSULFEX busulfan INJECTABLE;INJECTION 020954-001 Feb 4, 1999 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aspen Global Inc MYLERAN busulfan INJECTABLE;INJECTION 208536-001 Nov 20, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms Co BUSULFAN busulfan INJECTABLE;INJECTION 209580-001 Dec 18, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz Inc BUSULFAN busulfan INJECTABLE;INJECTION 205106-001 Jul 7, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aspen Global MYLERAN busulfan TABLET;ORAL 009386-001 Approved Prior to Jan 1, 1982 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Llc BUSULFAN busulfan INJECTABLE;INJECTION 205139-001 Dec 8, 2017 AP RX 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

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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Dow
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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