Zuplenz is a drug owned by Aquestive Therapeutics Inc. It is protected by 2 US drug patents filed from 2013 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 13, 2030. Details of Zuplenz'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). | |||
| US9095577 | Stabilized amine-containing actives in oral film compositions |
Jul, 2030
(5 years from now) | Active |
| US8580830 | Non-mucoadhesive film dosage forms |
Nov, 2029
(5 years from now) | Active |
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 Zuplenz's patents.
Latest Legal Activities on Zuplenz's Patents
Given below is the list of recent legal activities going on the following patents of Zuplenz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 |
| Recordation of Patent Grant Mailed Critical | 12 Nov, 2013 | US8580830 |
| Email Notification Critical | 24 Oct, 2013 | US8580830 |
US patents provide insights into the exclusivity only within the United States, but Zuplenz 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 Zuplenz's family patents as well as insights into ongoing legal events on those patents.
Zuplenz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zuplenz's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 13, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zuplenz Generic API suppliers:
Ondansetron is the generic name for the brand Zuplenz. 12 different companies have already filed for the generic of Zuplenz, with Chartwell Molecules having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zuplenz's generic
Alternative Brands for Zuplenz
There are several other brand drugs using the same active ingredient (Ondansetron) as Zuplenz. 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.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ondansetron, Zuplenz's active ingredient. Check the complete list of approved generic manufacturers for Zuplenz
About Zuplenz
Zuplenz is a drug owned by Aquestive Therapeutics Inc. Zuplenz uses Ondansetron as an active ingredient. Zuplenz was launched by Aquestive in 2010.
Approval Date:
Zuplenz was approved by FDA for market use on 02 July, 2010.
Active Ingredient:
Zuplenz uses Ondansetron as the active ingredient. Check out other Drugs and Companies using Ondansetron ingredient
Dosage:
Zuplenz is available in film form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG | FILM | Discontinued | ORAL |
| 8MG | FILM | Discontinued | ORAL |