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Dronabinol Patent Expiration

Dronabinol was first introduced by Alkem Laboratories Ltd in its drug Marinol on May 31, 1985. Another drug containing Dronabinol is Syndros. 7 different companies have introduced drugs containing Dronabinol.


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.

Given below is the list recent legal activities going on the following patents of Dronabinol.

Event Date Patent/Publication
Patent litigations
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) 20 Jul, 2022 US10265293
Email Notification 20 Jul, 2022 US10265293
Correspondence Address Change 19 Jul, 2022 US10265293
Patent Issue Date Used in PTA Calculation 22 Feb, 2022 US11253472
Recordation of Patent Grant Mailed 22 Feb, 2022 US11253472
Email Notification 03 Feb, 2022 US11253472
Issue Notification Mailed 02 Feb, 2022 US11253472
Application Is Considered Ready for Issue 14 Jan, 2022 US11253472



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Dronabinol Generics

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.


1. 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 Prescription ORAL AB Jun 27, 2008
5MG capsule Prescription ORAL AB Jun 27, 2008
10MG capsule Prescription ORAL AB Jun 27, 2008


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


3. 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


4. 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


5. 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