Ondansetron Patent Expiration

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.

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.

Given below is the list recent legal activities going on the following patents of Ondansetron.

Activity Date Patent Number
Patent litigations
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


Ondansetron's Family Patents

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.