Syndros is a drug owned by Benuvia Operations Llc. It is protected by 4 US drug patents filed from 2017 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 06, 2028. Details of Syndros's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9345771 | Oral cannabinoid formulations |
Aug, 2028
(3 years from now) | Active |
| US11253472 | Oral cannabinoid formulations |
Aug, 2028
(3 years from now) | Active |
| US8222292 | Liquid cannabinoid formulations |
Aug, 2028
(3 years from now) | Active |
| US10265293 | Oral cannabinoid formulations |
Aug, 2028
(3 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 Syndros's patents.
Latest Legal Activities on Syndros's Patents
Given below is the list of recent legal activities going on the following patents of Syndros.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Yr, Small Entity | 20 Nov, 2023 | US8222292 (Litigated) |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 21 Jul, 2022 | US10265293 |
| Change in Power of Attorney (May Include Associate POA) Critical | 20 Jul, 2022 | US10265293 |
| Email Notification Critical | 20 Jul, 2022 | US10265293 |
| Correspondence Address Change Critical | 19 Jul, 2022 | US10265293 |
| Patent Issue Date Used in PTA Calculation Critical | 22 Feb, 2022 | US11253472 |
| Recordation of Patent Grant Mailed Critical | 22 Feb, 2022 | US11253472 |
| Email Notification Critical | 03 Feb, 2022 | US11253472 |
| Issue Notification Mailed Critical | 02 Feb, 2022 | US11253472 |
| Application Is Considered Ready for Issue Critical | 14 Jan, 2022 | US11253472 |
US patents provide insights into the exclusivity only within the United States, but Syndros 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 Syndros's family patents as well as insights into ongoing legal events on those patents.
Syndros's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Syndros's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 06, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Syndros Generic API suppliers:
Dronabinol is the generic name for the brand Syndros. 5 different companies have already filed for the generic of Syndros, with Ascent Pharms Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Syndros's generic
How can I launch a generic of Syndros before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Syndros's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Syndros'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 Syndros -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/mL | 17 Apr, 2017 | 1 | 06 Aug, 2028 | Extinguished |
About Syndros
Syndros is a drug owned by Benuvia Operations Llc. Syndros uses Dronabinol as an active ingredient. Syndros was launched by Benuvia Operations in 2017.
Approval Date:
Syndros was approved by FDA for market use on 23 March, 2017.
Active Ingredient:
Syndros uses Dronabinol as the active ingredient. Check out other Drugs and Companies using Dronabinol ingredient
Dosage:
Syndros is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/ML | SOLUTION | Discontinued | ORAL |