Buprenorphine & Naloxone

Buprenorphine & Naloxone

IPR decision: Jun. 02, 2020

AIA Review #
Filing Date
Institution Decision Date
Petitioner
Patent
Respondent
FINAL WRITTEN DECISION
IPR2019-00329
11/13/2018
06/03/2019
Dr. Reddy’s Laboratories
9,687,454
Indivior UK Ltd
Some Challenged Claims Unpatentable
On US’ 454, DRL previously filed IPR IPR2019-00328 which was denied by PTAB on 06/03/2019.
US 9,687,454 (Indivior UK Limited; Exp: 08/07/2029) – OB listed
1. An oral, self-supporting, A mucoadhesive film comprising: (a) about 40 wt % to about 60 wt % of a water-soluble polymeric matrix; (b) about 2 mg to about 16 mg of buprenorphine or a pharmaceutically acceptable salt thereof; (c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable salt thereof; and (d) an acidic buffer; wherein the film is mucoadhesive to the sublingual mucosa or the buccal mucosa; wherein the weight ratio of (b):(c) is about 4:1; wherein the weight ratio of (d):(b) is from 2:1 to 1:5; and wherein application of the film on the sublingual mucosa or the buccal mucosa results in differing absorption between buprenorphine and naloxone, with a buprenorphine C.sub.max from about 0.624 ng/ml to about 5.638 ng/ml and a buprenorphine AUC from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml; and a naloxone Cmax from about 41.04 pg/ml to about 323.75 pg/ml and a naloxone AUC from about 102.88 hr*pg/ml to about 812.00 hr*pg/ml.

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