Naloxone hydrochloride (NARCAN) – USA

Naloxone hydrochloride (NARCAN) – USA

IPR decision: Aug. 21, 2020

AIA Review #

Filing Date

Institution Date

Petitioner

Patent

Respondent

Final Written Decision

IPR2019-00685

02/19/2019

08/27/2019

Nalox-1 Pharmaceuticals, LLC

9,211,253

Opiant Pharmaceuticals, Inc.

No Challenged Claims Unpatentable

IPR2019-00688

02/19/2019

09/09/2019

Nalox-1 Pharmaceuticals, LLC

9,468,747

Opiant Pharmaceuticals, Inc.

No Challenged Claims Unpatentable

IPR2019-00694

02/19/2019

09/11/2019

Nalox-1 Pharmaceuticals, LLC

9,629,965

Opiant Pharmaceuticals, Inc.

No Challenged Claims Unpatentable


On US’253, Nalox-1 Pharmaceuticals filed IPRs (IPR2019-00686 & IPR2019-00687) which were denied by PTAB.

On US’747, Nalox-1 Pharmaceuticals filed IPRs (IPR2019-00689 & IPR2019-00690) which were denied by PTAB.

On US’965, Nalox-1 Pharmaceuticals filed IPRs (IPR2019-00695 & IPR2019-00696) which were denied by PTAB.

US  9,211,253 (Lightlake Therapeutics Inc.; Exp: 03/16/2035):

1. A single-use, pre-primed device adapted for nasal delivery of a pharmaceutical composition to a patient by one actuation of said device into one nostril of said patient, having a single reservoir comprising a pharmaceutical composition which is an aqueous solution of about 100 .mu.L comprising: about 4 mg naloxone hydrochloride or a hydrate thereof; between about 0.2 mg and about 1.2 mg of an isotonicity agent; between about 0.005 mg and about 0.015 mg of a preservative; about 0.2 mg of a stabilizing agent; an amount of an acid sufficient to achieve a pH or 3.5-5.5.

US  9,468,747 (Lightlake Therapeutics Inc / Opiant pharma.; Exp: 03/16/2035):

1. A method of treatment of opioid overdose or a symptom thereof, comprising nasally administering to a patient in need thereof a dose of naloxone hydrochloride using a single-use, pre-primed device adapted for nasal delivery of a pharmaceutical composition to a patient by one actuation of said device into one nostril of said patient, having a single reservoir comprising a pharmaceutical composition which is an aqueous solution of about 100 .mu.L comprising: about 4 mg naloxone hydrochloride or a hydrate thereof; between about 0.2 mg and about 1.2 mg of an isotonicity agent; between about 0.005 mg and about 0.015 mg of a compound which is at least one of a preservative, a cationic surfactant, and a permeation enhancer; between about 0.1 mg and about 0.5 mg of a stabilizing agent; and an amount of an acid sufficient to achieve a pH of 3.5-5.5.

30. A pharmaceutical formulation for intranasal administration comprising, in an aqueous solution of not more than about 140 .mu.L: about 4 mg naloxone hydrochloride or a hydrate thereof; between about 0.2 mg and about 1.2 mg of an isotonicity agent; between about 0.005 mg and about 0.015 mg of a compound which is at least one of a preservative, a cationic surfactant, and a permeation enhancer; between about 0.1 mg and about 0.5 mg of a stabilizing agent; an amount of an acid sufficient to achieve a pH of 3.5-5.5.

US  9,629,965 (Opiant  pharma; Exp: 03/16/2035):

1. A pharmaceutical formulation for intranasal administration comprising, in an aqueous solution of not more than about 140 .mu.L: about 4 mg naloxone hydrochloride; about 0.74 mg NaCl; about 0.01 mg benzalkonium chloride; about 0.2 mg disodium edetate; and an amount of hydrochloric acid sufficient to achieve a pH of 3.5-5.5.

20. A single-use, pre-primed device adapted for nasal delivery of a pharmaceutical composition to a patient by one actuation of said device into one nostril of said patient, having a single reservoir comprising a pharmaceutical composition which comprises per 100 .mu.L of aqueous solution: about 4 mg naloxone hydrochloride or a hydrate thereof; between about 0.2 mg and about 1.2 mg of an isotonicity agent; between about 0.005 mg and about 0.015 mg of a preservative; between about 0.1 mg and about 0.5 mg of a stabilizing agent; and an amount of an acid sufficient to achieve a pH of 3.5-5.5.

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