Busulfan Patent Expiration

Busulfan is used for treating malignant conditions like leukemia and lymphoma in patients undergoing bone marrow transplants. It was first introduced by Waylis Therapeutics Llc in its drug Myleran on Approved Prior to Jan 1, 1982. Another drug containing Busulfan is Busulfex. 17 different companies have introduced drugs containing Busulfan.


Busulfan Patents

Given below is the list of patents protecting Busulfan, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Busulfex US5430057

(Pediatric)

Parenteral busulfan for treatment of malignant disease Mar 30, 2014

(Expired)

Otsuka Pharm
Busulfex US5559148

(Pediatric)

Parenteral busulfan for treatment of malignant disease Mar 30, 2014

(Expired)

Otsuka Pharm
Busulfex US5430057 Parenteral busulfan for treatment of malignant disease Sep 30, 2013

(Expired)

Otsuka Pharm
Busulfex US5559148 Parenteral busulfan for treatment of malignant disease Sep 30, 2013

(Expired)

Otsuka Pharm



Busulfan's Family Patents

Family Patents

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Busulfan Generic API Manufacturers

Several generic applications have been filed for Busulfan. The first generic version for Busulfan was by American Regent Inc and was approved on Dec 22, 2015. And the latest generic version is by Prinston Pharmaceutical Inc and was approved on Sep 11, 2024.

Given below is the list of companies who have filed for Busulfan generic, along with the locations of their manufacturing plants worldwide.