Viewing data from:

CASSIPA

NDA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | N208042 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
INDIVIOR INC. et al v. TEVA PHARMACEUTICALS USA, INC. 2:2017cv07115 1 patentbuprenorphine hydrochloride and naloxone hydrochloride	D.N.J.	2017-09-14	Terminated 2024-01-31	—
Indivior Inc. et al v. Teva Pharmaceuticals USA, Inc. 1:2016cv00178 5 patentsANDA 205299, 205806buprenorphine hydrochloride and naloxone hydrochloride	D. Del.	2016-03-21	Terminated 2019-09-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

10 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 16MG BASE;EQ 4MG BASE

RLD

0 patents0 exclusivities▴

FILM;SUBLINGUAL | Approved: Sep 7, 2018

No patent or exclusivity listings for this strength.