Zofran is a drug owned by Sandoz Inc. It is protected by 2 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 20, 2016. Details of Zofran'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). | |||
|
US5854270 (Pediatric) | Oral compositions containing ondansetron |
May, 2016
(8 years ago) |
Expired
|
| US5854270 | Oral compositions containing ondansetron |
Nov, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Zofran 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's family patents as well as insights into ongoing legal events on those patents.
Zofran's Family Patents
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Generic Launch
Generic Release Date:
Zofran's generic launch date based on the expiry of its last outstanding patent is estimated to be May 20, 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 Generic API suppliers:
Ondansetron Hydrochloride is the generic name for the brand Zofran. 40 different companies have already filed for the generic of Zofran, with Hospira having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zofran's generic
How can I launch a generic of Zofran before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zofran's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zofran'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg/mL, 2 mL vials (Preservative-free) | |||||
| 2 mg/mL, 20 mL vials | |||||
| 4 mg/5 mL | 20 Dec, 2004 | 1 | 26 Dec, 2006 | 20 May, 2016 | Eligible |
| 4 mg, 8 mg, 16 mg and 24 mg |
About Zofran
Zofran is a drug owned by Sandoz Inc. It is used for managing symptoms of nausea and vomiting. Zofran uses Ondansetron Hydrochloride as an active ingredient. Zofran was launched by Sandoz in 1997.
Approval Date:
Zofran was approved by FDA for market use on 24 January, 1997.
Active Ingredient:
Zofran uses Ondansetron Hydrochloride as the active ingredient. Check out other Drugs and Companies using Ondansetron Hydrochloride ingredient
Treatment:
Zofran is used for managing symptoms of nausea and vomiting.
Dosage:
Zofran is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 4MG BASE/5ML | SOLUTION | Discontinued | ORAL |