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 | A214737 | SUN PHARM INDUSTRIES
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
OREXO AB et al v. SUN PHARMACEUTICALS INDUSTRIES LIMITED et al 3 patentsANDA 214737buprenorphine and naloxone | D.N.J. | 2020-09-11 | Terminated 2023-07-20 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.