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 |
|---|---|---|---|---|
| Zofran Odt | US5955488 | Freeze-dried compositions |
Nov 14, 2015
(Expired) | Sandoz |
| Zofran Odt |
US5955488 (Pediatric) | Freeze-dried compositions |
May 14, 2016
(Expired) | Sandoz |
| Zofran Odt | US6063802 | Ondansetron freeze-dried dosage form compositions for oral administration |
Nov 14, 2015
(Expired) | Sandoz |
| Zofran Odt |
US6063802 (Pediatric) | Ondansetron freeze-dried dosage form compositions for oral administration |
May 14, 2016
(Expired) | Sandoz |
| Zuplenz | US8580830 | Non-mucoadhesive film dosage forms | Nov 23, 2029 | Aquestive |
| Zuplenz | US9095577 | Stabilized amine-containing actives in oral film compositions | Jul 13, 2030 | Aquestive |
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.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 | 05 Jul, 2021 | US8580830 |
| Change in Power of Attorney (May Include Associate POA) | 07 Apr, 2021 | US8580830 |
| Email Notification | 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 | 05 Apr, 2021 | US8580830 |
| Patent Issue Date Used in PTA Calculation | 12 Nov, 2013 | US8580830 |
| Recordation of Patent Grant Mailed | 12 Nov, 2013 | US8580830 |
| Email Notification | 24 Oct, 2013 | US8580830 |
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Ondansetron Generics
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.
1. 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 |
2. 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 |
3. 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 |
4. 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 |
5. 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 |
6. 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 |
7. 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 |
8. 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 |
9. 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 |
10. 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 |
11. 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 |
12. 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 |