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Serving leading biopharmaceutical companies globally:

Medtronic
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Generated: November 22, 2017

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 Sandoz Inc, Pharmascience Inc, Otsuka Pharm, Luitpold Pharms Inc, and Aspen Global, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

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

Pharmacology for busulfan

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
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;INJECTION207050-001Mar 24, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Otsuka Pharm
BUSULFEX
busulfan
INJECTABLE;INJECTION020954-001Feb 4, 1999APRXYesYes► Subscribe► Subscribe► Subscribe
Luitpold Pharms Inc
BUSULFAN
busulfan
INJECTABLE;INJECTION202259-001Dec 22, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
BUSULFAN
busulfan
INJECTABLE;INJECTION205106-001Jul 7, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Aspen Global
MYLERAN
busulfan
TABLET;ORAL009386-001Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: busulfan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm
BUSULFEX
busulfan
INJECTABLE;INJECTION020954-001Feb 4, 1999► Subscribe► Subscribe
Otsuka Pharm
BUSULFEX
busulfan
INJECTABLE;INJECTION020954-001Feb 4, 1999► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Argus Health
McKesson
Accenture
Farmers Insurance
Healthtrust
QuintilesIMS
Federal Trade Commission
Cantor Fitzgerald
Medtronic
Merck

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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