Zofran Odt is a drug owned by Sandoz Inc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 14, 2016. Details of Zofran Odt's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US5955488 (Pediatric) | Freeze-dried compositions |
May, 2016
(8 years ago) |
Expired
|
|
US6063802 (Pediatric) | Ondansetron freeze-dried dosage form compositions for oral administration |
May, 2016
(8 years ago) |
Expired
|
| US5955488 | Freeze-dried compositions |
Nov, 2015
(9 years ago) |
Expired
|
| US6063802 | Ondansetron freeze-dried dosage form compositions for oral administration |
Nov, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Zofran Odt is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Zofran Odt's family patents as well as insights into ongoing legal events on those patents.
Zofran Odt's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zofran Odt's generic launch date based on the expiry of its last outstanding patent is estimated to be May 14, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zofran Odt Generic API suppliers:
Ondansetron is the generic name for the brand Zofran Odt. 12 different companies have already filed for the generic of Zofran Odt, with Chartwell Molecules having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zofran Odt's generic
How can I launch a generic of Zofran Odt before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zofran Odt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zofran Odt's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Zofran Odt -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 4 mg and 8 mg |
Alternative Brands for Zofran Odt
There are several other brand drugs using the same active ingredient (Ondansetron) as Zofran Odt. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ondansetron, Zofran Odt's active ingredient. Check the complete list of approved generic manufacturers for Zofran Odt
About Zofran Odt
Zofran Odt is a drug owned by Sandoz Inc. Zofran Odt uses Ondansetron as an active ingredient. Zofran Odt was launched by Sandoz in 1999.
Approval Date:
Zofran Odt was approved by FDA for market use on 27 January, 1999.
Active Ingredient:
Zofran Odt uses Ondansetron as the active ingredient. Check out other Drugs and Companies using Ondansetron ingredient
Dosage:
Zofran Odt is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |