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.


1. ACCORD HLTHCARE INC

Accord Healthcare Inc Usa has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Accord Hlthcare Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Prescription INJECTION AP Feb 22, 2019





2. ACTAVIS

Actavis Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Actavis.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Discontinued INJECTION N/A Dec 8, 2017


Manufacturing Plant Locations
New

Actavis's manufacturing plants are situated in 4 countries - Romania, United States, Italy, India. Given below are the details of these plant locations as well as the firm names of Actavis as present at those locations.

Country City Firm Name
Romania
Bucuresti Actavis
United States
Salt Lake City Actavis Laboratories UT, Inc.
Morristown Actavis Inc.
Davie Actavis Laboratories FL, Inc.
Edison Actavis LLC
Little Falls Actavis Totowa LLC
Mt Prospect Actavis Incorporated
Sunrise Actavis South Atlantic LLC
Weston Actavis Laboratories FL Inc.
Sunrise Actavis Laboratories FL, Inc.
Totowa Actavis Totowa LLC
Elizabeth Actavis Elizabeth LLC, A Company of Teva
Italy
Nerviano Actavis Italy Spa A Socio Unico
India
Chennai Actavis Pharma Development Centre Private Ltd





3. AM REGENT

American Regent Inc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Am Regent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Discontinued INJECTION N/A Dec 22, 2015





4. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Prescription INJECTION AP Dec 18, 2017


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited





5. APOTEX

Apotex Inc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Prescription INJECTION AP May 7, 2019


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.





6. ARTHUR GRP

Arthur Group Llc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Arthur Grp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Discontinued INJECTION N/A Sep 21, 2018





7. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Prescription INJECTION AP Jun 25, 2024


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited





8. HOSPIRA

Hospira Inc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Prescription INJECTION AP Jul 31, 2018


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Rocky Mount Hospira, Inc.
Clayton Hospira, Inc.
Morgan Hill Hospira Inc
Mcpherson Hospira, Inc., A Pfizer Company
Lake Forest Hospira Inc
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





9. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Prescription INJECTION AP Oct 23, 2020





10. MYLAN INSTITUTIONAL

Mylan Institutional Inc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Mylan Institutional.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Prescription INJECTION AP Nov 20, 2017


Manufacturing Plant Locations
New

Mylan Institutional's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Mylan Institutional as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.





11. NEXUS

Nexus Pharmaceuticals Llc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Nexus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Discontinued INJECTION N/A Jan 14, 2019


Manufacturing Plant Locations
New

Nexus's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Nexus as present at those locations.

Country City Firm Name
United States
Adams Nexus Cooperative
San Diego Nexus Dx, Inc
Brownsdale Nexus Cooperative
Cottonwood Heights Nexus CMF, LLC
Salt Lake City Nexus Spine, LLC
Bedford Park Nexus Distribution Corporation
Le Roy Nexus Cooperative
Lansing Nexus Cooperative
Alden Nexus Cooperative
Lenexa Nexus Medical LLC
Rose Creek Nexus Cooperative
Emmons Nexus Cooperative
Conger Nexus Cooperative
Cerritos Nexus Foods Inc
Pleasant Prairie Nexus Pharmaceuticals Inc
Lincolnshire Nexus Pharmaceuticals, LLC
Bedford Park Nexus Distribution Corp.
Santa Fe Springs Nexus Foods, Inc.





12. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Discontinued INJECTION N/A Jul 13, 2018





13. PHARMASCIENCE INC

Pharmascience Inc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Pharmascience Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Prescription INJECTION AP Mar 24, 2017


Manufacturing Plant Locations
New

Pharmascience Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Pharmascience Inc as present at those locations.

Country City Firm Name
Canada
Montreal Pharmascience Inc.
La Prairie Pharmascience Inc.





14. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Prescription INJECTION AP Sep 11, 2024





15. SHILPA

Shilpa Medicare Ltd has filed for 1 generic for Busulfan. Given below are the details of the strengths of this generic introduced by Shilpa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6MG/ML

injectable Prescription INJECTION AP Apr 18, 2019


Manufacturing Plant Locations
New

Shilpa's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Shilpa as present at those locations.

Country City Firm Name
United States
Minneapolis Shilpa Gupta
India
Hyderbad Shilpa Medicare Limited
Bengaluru Shilpa Medicare Limited
Polepally, Jadcherla Shilpa Medicare Limited
Hyderabad Shilpa Medicare Limited
Chicksugur, Raichur Shilpa Pharma Lifesciences Limited