Busulfex is a drug owned by Otsuka Pharmaceutical Co Ltd. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 30, 2014. Details of Busulfex's patents and their expiration are given in the table below.
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Drug Patent Number
Drug Patent Title
Drug Patent Expiry
Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration
(oral, tablet,
capsules, liquids etc).
Parenteral busulfan for treatment of malignant disease
Sep, 2013
(13 years ago)
Expired
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US patents provide insights into the exclusivity only within the United States, but
Busulfex is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Busulfex's family patents as well as insights into
ongoing legal events
on those patents.
Busulfex's Family Patents
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NCE-1 Patent Expiry in the Next 1 Year
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Recently Granted Patents in EP
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Clinical Trials
Recent Clinical Trials on Busulfex:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Center for International Blood and Marrow Transplant Research
NA
RECRUITING
(Mar 1, 2026)
PHASE2
Generic Launch
Generic Release Date:
Busulfex's
generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 30, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Busulfex Generic
API
suppliers:
Busulfan is the generic name
for
the brand Busulfex.
15 different companies have already filed for the generic of Busulfex, with Accord Hlthcare Inc having the maximum number of approved applications.
Check out the entire list of companies
who have already received approval for Busulfex's
generic
How can I launch a generic of Busulfex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before
the expiration of Busulfex's patents related
by providing a 'paragraph IV certification' in your
application, which states that the patent submitted by the
Busulfex's sponsor is invalid, unenforceable,
or will not be infringed by your generic product.
Given below are the details of the already filed Para IV
certificates on Busulfex -
Busulfex is a drug owned by Otsuka Pharmaceutical Co Ltd. It is used for treating malignant conditions like leukemia and lymphoma in patients undergoing bone marrow transplants. Busulfex uses Busulfan as an active ingredient. Busulfex was launched by Otsuka in 1999.
Approval Date:
Busulfex was approved by
FDA for market
use on 04 February, 1999.
