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 |
|---|---|---|
 | ||
| Expire Patent | 15 Dec, 2025 | US8580830 |
| Maintenance Fee Reminder Mailed | 30 Jun, 2025 | US8580830 |
| 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 |
Ondansetron's Family Patents
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Clinical Trials
Recent Clinical Trials on Ondansetron:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
