Syndros is a drug owned by Wellhouse Pharma 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. | |||
| US10265293 | Oral cannabinoid formulations |
Aug, 2028
(1 year, 9 months from now) | Active |
| US8222292 | Liquid cannabinoid formulations |
Aug, 2028
(1 year, 9 months from now) | Active |
| US9345771 | Oral cannabinoid formulations |
Aug, 2028
(1 year, 9 months from now) | Active |
| US11253472 | Oral cannabinoid formulations |
Aug, 2028
(1 year, 9 months 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, 4th Yr, Small Entity | 12 Jun, 2025 | US11253472 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 20 Nov, 2023 | US8222292 (Litigated) |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 20 Nov, 2023 | US9345771 (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 |
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
Clinical Trials
Recent Clinical Trials on Syndros:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Synthetic THC And Blood Pressure | Mayo Clinic | NA | NOT YET RECRUITING
(Sep 1, 2026) | PHASE2, PHASE3 |
| A Study Of Synthetic THC And Sleep | Mayo Clinic | NA | NOT YET RECRUITING
(Sep 1, 2026) | PHASE2, PHASE3 |
| Endocannabinoids in Reward | Medical University of South Carolina | NA | NOT YET RECRUITING
(Sep 1, 2026) | PHASE2 |
| Reducing Breathlessness With Dronabinol in COPD Patients | Vejle Hospital | NA | ACTIVE NOT RECRUITING
(Aug 1, 2026) | PHASE3 |
| DRonabinol Treatment of OSA | VA Office of Research and Development | NA | RECRUITING
(Aug 1, 2026) | PHASE1, PHASE2 |
| Dronabinol After Arthroscopic Surgery | Northwestern University | NA | ACTIVE NOT RECRUITING
(May 1, 2026) | PHASE3 |
| Sex Differences in Neurobehavioral Response to THC | Medical University of South Carolina | NA | TERMINATED
(May 1, 2026) | PHASE2 |
| Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III | Yale University | NA | ACTIVE NOT RECRUITING
(Apr 1, 2026) | PHASE1 |
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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 17 Apr, 2017 | 06 Aug, 2028 | Extinguished | Less |
About Syndros
Syndros is a drug owned by Wellhouse Pharma Llc. Syndros uses Dronabinol as an active ingredient. Syndros was launched by Wellhouse 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | ORAL |