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Last Updated: August 4, 2021

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Details for Patent: 9,517,307


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Which drugs does patent 9,517,307 protect, and when does it expire?

Patent 9,517,307 protects EVZIO and EVZIO (AUTOINJECTOR) and is included in two NDAs.

Summary for Patent: 9,517,307
Title:Devices and methods for delivering opioid antagonists including formulations for naloxone
Abstract: An apparatus includes a container, a needle, and an actuation assembly. The container contains a dose of a naloxone composition having a delivered volume of at least about 0.34 mL. The actuation assembly includes an energy storage member that produces a force on a movable member to move the needle and to deliver the dose of the naloxone composition. The 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after dose delivery into the body (C.sub.max), time to reach the maximum naloxone plasma concentration (T.sub.max), area under the plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC.sub.0-.infin.), or area under the plasma concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (T.sub.last) (AUC.sub.0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%.
Inventor(s): Blondino; Frank E. (Henrico, VA), Edwards; Eric S. (Moseley, VA), Edwards; Evan T. (Charlottesville, VA), Kelley; Glen L. (Glen Allen, VA), Meyers; Paul F. (Fishers, IN)
Assignee: kaleo, Inc. (Richmond, VA)
Application Number:14/335,490
Patent Claim Types:
see list of patent claims
Composition; Device; Delivery; Dosage form; Use;

Drugs Protected by US Patent 9,517,307

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Kaleo Inc EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787-001 Apr 3, 2014 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y USE OF AN AUTO INJECTOR TO ADMINISTER NALOXONE HCL ⤷  Free Forever Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y USE OF AN AUTO INJECTOR TO ADMINISTER NALOXONE HCL ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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