Details for Patent: 10,220,158
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 (Cmax), time to reach the maximum naloxone plasma concentration (Tmax), area under the plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC0-∞), or area under the plasma concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (Tlast) (AUC0-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): | Frank E. Blondino, Eric S. Edwards, Evan T. Edwards, Glen L. Kelley, Paul F. Meyers |
| Assignee: | kaleo Inc |
| Application Number: | US15/371,515 |
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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 | 10,220,158 | ⤷ 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 | DISCN | Yes | No | 10,220,158 | ⤷ 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 |
