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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
Sunrise Actavis Laboratories FL, Inc.
Mt Prospect Actavis Incorporated
Sunrise Actavis South Atlantic LLC
Little Falls Actavis Totowa LLC
Weston Actavis Laboratories FL Inc.
Salt Lake City Actavis Laboratories UT, Inc.
Totowa Actavis Totowa LLC
Elizabeth Actavis Elizabeth LLC, A Company of Teva
Morristown Actavis Inc.
Davie Actavis Laboratories FL, Inc.
Edison Actavis LLC
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
Hauppauge Amneal Pharmaceuticals of New York, LLC
Piscataway Amneal Pharmaceuticals, LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Branchburg Amneal Pharmaceuticals, LLC
India
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.





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 Discontinued INJECTION N/A 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
Toronto Apotex Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
Richmond Hill Apotex Inc.
North York Apotex Inc.
Brantford Apotex Pharmachem Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bangalore Apotex Pharmachem India Pvt Ltd.
Bengaluru Apotex Research Private Limited





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 Discontinued INJECTION N/A 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
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Pashamylaram 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
Lake Forest Hospira Inc
Mcpherson Hospira, Inc., A Pfizer Company
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
Cottonwood Heights Nexus CMF, LLC
Santa Fe Springs Nexus Foods, Inc.
Brownsdale Nexus Cooperative
Alden Nexus Cooperative
Bedford Park Nexus Distribution Corp.
Pleasant Prairie Nexus Pharmaceuticals Inc
Salt Lake City Nexus Spine, LLC
San Diego Nexus Dx, Inc
Rose Creek Nexus Cooperative
Lansing Nexus Cooperative
Lenexa Nexus Medical LLC
Lincolnshire Nexus Pharmaceuticals, LLC
Conger Nexus Cooperative
Cerritos Nexus Foods Inc
Le Roy Nexus Cooperative
Adams Nexus Cooperative
Bedford Park Nexus Distribution Corporation
Emmons Nexus Cooperative





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
La Prairie Pharmascience Inc.
Montreal 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
Hyderabad Shilpa Medicare Limited
Bengaluru Shilpa Medicare Limited
Polepally, Jadcherla Shilpa Medicare Limited
Hyderbad Shilpa Medicare Limited
Chicksugur, Raichur Shilpa Pharma Lifesciences Limited