Ondansetron Patent Expiration
Ondansetron was first introduced by Sandoz Inc
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.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Zuplenz | US9095577 | Stabilized amine-containing actives in oral film compositions | Jul 13, 2030 | Aquestive |
| Zuplenz | US8580830 | Non-mucoadhesive film dosage forms | Nov 23, 2029 | Aquestive |
| Zofran Odt |
US5955488 (Pediatric) | Freeze-dried compositions |
May 14, 2016
(Expired) | Sandoz |
| Zofran Odt |
US6063802 (Pediatric) | Ondansetron freeze-dried dosage form compositions for oral administration |
May 14, 2016
(Expired) | Sandoz |
| Zofran Odt | US5955488 | Freeze-dried compositions |
Nov 14, 2015
(Expired) | Sandoz |
| Zofran Odt | US6063802 | Ondansetron freeze-dried dosage form compositions for oral administration |
Nov 14, 2015
(Expired) | Sandoz |
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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 27 Oct, 2021 | US8580830 |
| 7.5 yr surcharge - late pmt w/in 6 mo, Small Entity | 27 Oct, 2021 | US8580830 |
| Maintenance Fee Reminder Mailed Critical | 05 Jul, 2021 | US8580830 |
| Change in Power of Attorney (May Include Associate POA) Critical | 07 Apr, 2021 | US8580830 |
| Email Notification Critical | 07 Apr, 2021 | US8580830 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 06 Apr, 2021 | US8580830 |
| Correspondence Address Change Critical | 05 Apr, 2021 | US8580830 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Nov, 2013 | US8580830 |
| Recordation of Patent Grant Mailed Critical | 12 Nov, 2013 | US8580830 |
| Email Notification Critical | 24 Oct, 2013 | US8580830 |
Ondansetron's Family Patents
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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 |
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| United States |
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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.
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| United States |
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| Philippines |
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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 | Discontinued | ORAL | N/A | Oct 30, 2023 |
| 8MG | tablet, orally disintegrating | Discontinued | ORAL | N/A | Oct 30, 2023 |
6. 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 |
7. NORVIUM BIOSCIENCE
Norvium Bioscience 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 Norvium Bioscience.
| 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 |
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 |
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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 | ||||
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| Austria |
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| United States |
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| Spain |
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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.
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| United States |
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| India |
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| Canada |
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| Czech Republic |
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| Ireland |
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| Israel |
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