Dronabinol Patent Expiration
Dronabinol was first introduced by Alkem Laboratories Ltd
Dronabinol Patents
Given below is the list of patents protecting Dronabinol, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Syndros | US10265293 | Oral cannabinoid formulations | Aug 06, 2028 | Benuvia Operations |
| Syndros | US11253472 | Oral cannabinoid formulations | Aug 06, 2028 | Benuvia Operations |
| Syndros | US8222292 | Liquid cannabinoid formulations | Aug 06, 2028 | Benuvia Operations |
| Syndros | US9345771 | Oral cannabinoid formulations | Aug 06, 2028 | Benuvia Operations |
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 Dronabinol's patents.
Latest Legal Activities on Dronabinol's Patents
Given below is the list recent legal activities going on the following patents of Dronabinol.
| 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 |
Dronabinol's Family Patents
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Dronabinol Generic API Manufacturers
Several generic applications have been filed for Dronabinol. The first generic version for Dronabinol was by Svc Pharma Lp and was approved on Jun 27, 2008. And the latest generic version is by Ascent Pharmaceuticals Inc and was approved on Feb 7, 2020.
Given below is the list of companies who have filed for Dronabinol generic, along with the locations of their manufacturing plants worldwide.
1. ASCENT PHARMS INC
Ascent Pharmaceuticals Inc has filed for 3 different strengths of generic version for Dronabinol. Given below are the details of the strengths of this generic introduced by Ascent Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | capsule | Prescription | ORAL | AB | Feb 7, 2020 |
| 5MG | capsule | Prescription | ORAL | AB | Feb 7, 2020 |
| 10MG | capsule | Prescription | ORAL | AB | Feb 7, 2020 |
2. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Dronabinol. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | capsule | Discontinued | ORAL | N/A | Jun 20, 2014 |
| 5MG | capsule | Discontinued | ORAL | N/A | Jun 20, 2014 |
| 10MG | capsule | Discontinued | ORAL | N/A | Jun 20, 2014 |
Manufacturing Plant Locations New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Portugal |
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| Jordan |
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3. INSYS THERAP
Insys Therapeutics Inc has filed for 3 different strengths of generic version for Dronabinol. Given below are the details of the strengths of this generic introduced by Insys Therap.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | capsule | Discontinued | ORAL | N/A | Aug 19, 2011 |
| 5MG | capsule | Discontinued | ORAL | N/A | Aug 19, 2011 |
| 10MG | capsule | Discontinued | ORAL | N/A | Aug 19, 2011 |
Manufacturing Plant Locations New
Insys Therap's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Insys Therap as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
4. LANNETT CO INC
Lannett Co Inc has filed for 3 different strengths of generic version for Dronabinol. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | capsule | Discontinued | ORAL | N/A | May 18, 2018 |
| 10MG | capsule | Discontinued | ORAL | N/A | May 18, 2018 |
| 2.5MG | capsule | Discontinued | ORAL | N/A | May 18, 2018 |
5. SVC PHARMA
Svc Pharma Lp has filed for 3 different strengths of generic version for Dronabinol. Given below are the details of the strengths of this generic introduced by Svc Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | capsule | Discontinued | ORAL | N/A | Jun 27, 2008 |
| 5MG | capsule | Discontinued | ORAL | N/A | Jun 27, 2008 |
| 10MG | capsule | Discontinued | ORAL | N/A | Jun 27, 2008 |