DRONABINOL | N205525 | WELLHOUSE PHARMA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Insys Therapeutics, Inc. et al v. Alkem Laboratories Ltd. et al 2 patentsANDA 210825dronabinol oral solution | D. Del. | 2017-10-10 | Terminated 2018-07-13 | — |
Insys Therapeutics, Inc. et al v. Endo Generics Holdings, Inc. et al 2 patentsANDA 210314dronabinol oral solution | S.D.N.Y. | 2017-08-07 | Terminated 2017-09-08 | — |
| D. Del. | 2017-08-03 | Terminated 2018-03-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Insys Therapeutics, Inc. FDA-2017-P-6411 · 3 docket documents Insys Therapeutics, Inc. filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require in vivo bioequivalence studies for any Abbreviated New Drug Application referencing its SYNDROS (dronabinol) oral solution, approved under | 505(q) | 2017-11-08 | Denied | Insys Therapeutics, Inc. |
Summit Biosciences, Inc., et al (K&L Gates, LLC) - Citizen Petition FDA-2010-P-0353 · 6 docket documents Summit Biosciences Inc. and an unnamed Kentucky university filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine a new nasal spray dosage form of dronabinol (synthetic delta-9-tetrahydrocannabinol) is suitable for filing unde | Other | 2010-07-06 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.