Ondansetron was first introduced by Sandoz Inc in its drug Zofran Odt on Jan 27, 1999. Another drug containing Ondansetron is Zuplenz. 13 different companies have introduced drugs containing Ondansetron.
Ondansetron Patents
Given below is the list of patents protecting Ondansetron, along
with the drug name that holds that patent and the company name owning that
drug.
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ondansetron's patents.
Latest Legal Activities on Ondansetron's Patents
Given below is the list recent legal activities going on the following patents of Ondansetron.
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Ondansetron Generic API Manufacturers
Several generic applications have been filed for Ondansetron. The first generic version for Ondansetron was by Chartwell Molecules Llc and was approved on Dec 26, 2006. And the latest generic version is by Ipca Laboratories Ltd and was approved on Oct 30, 2023.
Given below is the list of companies who have filed for
Ondansetron generic, along with the locations of their manufacturing plants worldwide.
1. AUROBINDO PHARMA
Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Aurobindo Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
4MG
tablet, orally disintegrating
Prescription
ORAL
AB
Apr 12, 2010
8MG
(reference standard)
tablet, orally disintegrating
Prescription
ORAL
AB
Apr 12, 2010
Manufacturing Plant Locations
New
Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.
Country
City
Firm Name
India
Medchal
Aurobindo Pharma Ltd
Sangareddy
Aurobindo Pharma Limited
Bachupally
Aurobindo Pharma Limited
Polepally, Mahaboob Nagar
Aurobindo Pharma Limited
United States
East Windsor
Aurobindo Pharma USA Inc
2. BARR
Barr Laboratories Inc has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Barr.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
4MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Jun 25, 2007
8MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Jun 25, 2007
Manufacturing Plant Locations
New
Barr's manufacturing plants are situated in 4 countries - Mexico, Singapore, United States, Philippines. Given below are the details of these plant locations as well as the firm names of Barr as present at those locations.
Country
City
Firm Name
Mexico
Aldama
Barra La Coma, S. De R.L
Singapore
Singapore
Barramundi Asia Pte Ltd
United States
Somerset
Barrett Distribution Centers Inc
Englewood
Barrett E. Cowan, MD
Curtis Bay
Barrett Distribution Center
Hereford
Barrett and Crofoot Feedyard, West
Forest
Barr Laboratories Inc.
Arecibo
Barreto Dairy, Inc.
Barrett
Barrett Farm Supply, Inc.
Randolph
Barrett Farm
Davie
Barrier Technologies LLC
Belvidere
Barred Woods, LLC
Harrison
Barrington Chemical Corporation
Franklin
Barrett Distribution Centers, Inc.
Lee
Barrington Coffee Roasting Company, Inc.
Buffalo
Barrel and Brine Inc
Commerce
Barreras Meat Co
Live Oak
Barrington Dairy Farm
Newton
Barrett Technology, LLC
Memphis
Barrett Distribution Centers
Swartz Creek
Barrett Donut Mixes, Inc..
Paso Robles
Barreto Cellars
Lake Barrington
Barrington Ventures, Ltd
Greenwood
Barr Enterprises, Inc.
Hereford
Barrett and Crofoot, LLP
Machipongo
Barrier Island Seafood
Dillon
Barretts Minerals Inc
Brainerd
Barrett Ag Service, Inc.
Montezuma
Barrington Dairies
Madison
Barriques Holding Company, LLC
Philippines
Bulacan
Barrio Fiesta Manufacturing Corporation
3. CHARTWELL MOLECULES
Chartwell Molecules Llc has filed for 4 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Chartwell Molecules.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
16MG
(reference standard)
tablet, orally disintegrating
Prescription
ORAL
N/A
Dec 26, 2006
24MG
(reference standard)
tablet, orally disintegrating
Prescription
ORAL
N/A
Dec 26, 2006
8MG
tablet, orally disintegrating
Prescription
ORAL
AB
Dec 26, 2006
4MG
tablet, orally disintegrating
Prescription
ORAL
AB
Dec 26, 2006
4. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Glenmark Pharms Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
4MG
tablet, orally disintegrating
Prescription
ORAL
AB
Jun 27, 2007
8MG
tablet, orally disintegrating
Prescription
ORAL
AB
Jun 27, 2007
5. IPCA LABS LTD
Ipca Laboratories Ltd has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Ipca Labs Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
4MG
tablet, orally disintegrating
Prescription
ORAL
AB
Oct 30, 2023
8MG
tablet, orally disintegrating
Prescription
ORAL
AB
Oct 30, 2023
6. MYLAN
Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Mylan.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
4MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Jun 25, 2007
8MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Jun 25, 2007
Manufacturing Plant Locations
New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
Country
City
Firm Name
United States
Saint Albans
Mylan Technologies, Inc.
Santa Barbara
Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos
Mylan Pharmaceuticals Inc.
Rockford
Mylan Institutional, Inc.
Morgantown
Mylan Specialty, L.P.
Morgantown
MYLAN CONSUMER HEALTHCARE Inc.
Greensboro
Mylan Pharmaceuticals Inc
India
Sarigam
Mylan Laboratories Limited
Hyderabad
Mylan Laboratories Limited
Anekal Taluk, Bangalore
Mylan Laboratories Limited
Sinnar
Mylan Laboratories Limited
Aurangabad
Mylan Laboratories Limited (FDF-2)
Hosur
Mylan Laboratories Limited
Bangalore
Mylan Laboratories Limited
Pithampur, District Dhar
Mylan Laboratories Limited
Canada
Etobicoke
Mylan Pharmaceuticals ULC
Ireland
Inverin
Mylan Teoranta
7. NESHER PHARMS
Nesher Pharmaceuticals Usa Llc has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Nesher Pharms.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
8MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Jun 25, 2007
4MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Jun 25, 2007
8. PAR PHARM
Par Pharmaceutical Inc has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Par Pharm.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
4MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Dec 26, 2006
8MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Dec 26, 2006
Manufacturing Plant Locations
New
Par Pharm'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 Par Pharm as present at those locations.
Country
City
Firm Name
United States
Stratford
Par Pharmaceutical Inc.
Hauppauge
Par Pharmaceuticals
9. SANDOZ
Sandoz Inc has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Sandoz.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
4MG
tablet, orally disintegrating
Prescription
ORAL
AB
Aug 13, 2007
8MG
tablet, orally disintegrating
Prescription
ORAL
AB
Aug 13, 2007
Manufacturing Plant Locations
New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
Country
City
Firm Name
Austria
Kundl
Sandoz GmbH
Langkampfen
Sandoz GmbH
United States
East Hanover
Sandoz Incorporated
Princeton
Sandoz Inc
Spain
Palafolls
Sandoz Industrial Products, S.A.
Les Franqueses Del Valles
Sandoz Industrial Products S.A.
India
Navi Mumbai
Sandoz Private Limited
10. SUN PHARM INDS
Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Sun Pharm Inds.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
8MG
tablet, orally disintegrating
Prescription
ORAL
AB
Aug 2, 2007
4MG
tablet, orally disintegrating
Prescription
ORAL
AB
Aug 2, 2007
11. SUN PHARM INDS LTD
Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Sun Pharm Inds Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
8MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Feb 24, 2011
4MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Feb 24, 2011
12. TEVA
Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Ondansetron. Given below are the
details of the strengths of this generic introduced by
Teva.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
4MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Jun 25, 2007
8MG
tablet, orally disintegrating
Discontinued
ORAL
N/A
Jun 25, 2007
Manufacturing Plant Locations
New
Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.
