Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | A204383 | ACTAVIS LABS UT INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Indivior Inc. et al v. Actavis Laboratories UT, Inc. 3 patentsANDA 204383, 207087buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2018-04-04 | Terminated 2019-09-16 | — |
Indivior Inc. et al v. Actavis Laboratories UT, Inc. 1 patentANDA 204383, 207087buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2018-04-03 | Terminated 2019-09-16 | — |
Indivior et al v. Actavis Laboratories UT 2 patentsANDA 204383, 207087buprenorphine hydrochloride and naloxone hydrochloride | UTD | 2018-02-07 | Terminated 2018-05-03 | — |
Reckitt Benckiser Pharmaceuticals Inc. et al v. Watson Laboratories Inc. et al. 2 patentsANDA 204383buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2014-12-31 | Terminated 2019-10-01 | — |
Reckitt Benckiser Pharmaceuticals Inc. et al v. Watson Laboratories Inc., et al. 2 patentsANDA 204383buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2013-10-08 | Terminated 2019-09-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.