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BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

ANDA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | A207607 | MYLAN TECHNOLOGIES INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SUBOXONE(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Indivior Inc. et al v. Mylan Technologies Inc. et al 1:2015cv01016 3 patentsANDA 207607buprenorphine hydrochloride and naloxone hydrochloride	D. Del.	2015-11-04	Terminated 2019-09-05	—

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 20, 2018	ORIG -1	View Letter (PDF)
Jun 20, 2018	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 8MG BASE;EQ 2MG BASE

0 patents0 exclusivities▴

FILM;BUCCAL, SUBLINGUAL | Approved: Jun 14, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 12MG BASE;EQ 3MG BASE

0 patents0 exclusivities▾

FILM;BUCCAL, SUBLINGUAL | Approved: Jun 14, 2018