FDA Orange Book · active-ingredient family
Dronabinol
Dronabinol is approved as 2 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SYNDROS · NDA 205525
2
Brand (NDA)
5
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SYNDROSRLD | WELLHOUSE PHARMA | NDA 205525 | — | Mar 23, 2017 | |
| MARINOLRLD×3 | ALKEM LABS LTD | NDA 018651 | AB | May 31, 1985 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DRONABINOL×3 | ASCENT PHARMS INC | ANDA 207421 | AB | Feb 07, 2020 | |
| DRONABINOL×3 | LANNETT CO INC | ANDA 201463 | — | May 18, 2018 | |
| DRONABINOL×3 | HIKMA | ANDA 079217 | — | Jun 20, 2014 | |
| DRONABINOL×3 | INSYS THERAP | ANDA 078501 | — | Aug 19, 2011 | |
| DRONABINOL×3 | RHODES | ANDA 078292 | — | Jun 27, 2008 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10265293 | Aug 06, 2028 | in 2 yr 2 mo | SubstanceProduct |
| 9345771 | Aug 06, 2028 | in 2 yr 2 mo | SubstanceProduct |
| 11253472 | Aug 06, 2028 | in 2 yr 2 mo | SubstanceProduct |
| 8222292 | Aug 06, 2028 | in 2 yr 2 mo | SubstanceProduct |
Dronabinol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
