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Last Updated: September 20, 2020

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Details for Patent: 10,220,158

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Which drugs does patent 10,220,158 protect, and when does it expire?

Patent 10,220,158 protects EVZIO and EVZIO (AUTOINJECTOR) and is included in two NDAs.

Summary for Patent: 10,220,158
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:15/371,515
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery; Device; Dosage form;

Drugs Protected by US Patent 10,220,158

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   Start Trial   Start Trial Y USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE   Start Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes   Start Trial   Start Trial Y USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE   Start 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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