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