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.
| 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). | |||
|
US5430057 (Pediatric) | Parenteral busulfan for treatment of malignant disease |
Mar, 2014
(10 years ago) |
Expired
|
|
US5559148 (Pediatric) | Parenteral busulfan for treatment of malignant disease |
Mar, 2014
(10 years ago) |
Expired
|
| US5559148 | Parenteral busulfan for treatment of malignant disease |
Sep, 2013
(11 years ago) |
Expired
|
| US5430057 | Parenteral busulfan for treatment of malignant disease |
Sep, 2013
(11 years ago) |
Expired
|
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
Explore Our Curated Drug Screens
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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 6 mg/mL | 26 Dec, 2012 | 1 | 21 Sep, 2018 | 30 Sep, 2013 | Extinguished |
About 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 Pharm in 1999.
Approval Date:
Busulfex was approved by FDA for market use on 04 February, 1999.
Active Ingredient:
Busulfex uses Busulfan as the active ingredient. Check out other Drugs and Companies using Busulfan ingredient
Treatment:
Busulfex is used for treating malignant conditions like leukemia and lymphoma in patients undergoing bone marrow transplants.
Dosage:
Busulfex is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6MG/ML | INJECTABLE | Prescription | INJECTION |