Details for New Drug Application (NDA): 209862
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NDA 209862 describes EVZIO (AUTOINJECTOR), which is a drug marketed by Kaleo Inc and is included in one NDA. There are twenty-one patents protecting this drug. Additional details are available on the EVZIO (AUTOINJECTOR) profile page.
The generic ingredient in EVZIO (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
The generic ingredient in EVZIO (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 209862
| Tradename: | EVZIO (AUTOINJECTOR) |
| Applicant: | Kaleo Inc |
| Ingredient: | naloxone hydrochloride |
| Patents: | 21 |
Medical Subject Heading (MeSH) Categories for 209862
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 2MG/0.4ML (2MG/0.4ML) | ||||
| Approval Date: | Oct 19, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 10,143,792 | Patent Expiration: | May 24, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE | ||||||||
| Patent: | 10,220,158 | Patent Expiration: | Mar 20, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE | ||||||||
| Patent: | 10,322,239 | Patent Expiration: | Feb 28, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE | ||||||||
Expired US Patents for NDA 209862
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kaleo Inc | EVZIO (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | 9,278,182 | ⤷ Start Trial |
| Kaleo Inc | EVZIO (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | 7,918,823 | ⤷ Start Trial |
| Kaleo Inc | EVZIO (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | 10,737,028 | ⤷ Start Trial |
| Kaleo Inc | EVZIO (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | 10,314,977 | ⤷ Start Trial |
| Kaleo Inc | EVZIO (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | 8,926,594 | ⤷ Start Trial |
| Kaleo Inc | EVZIO (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | 7,731,690 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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