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Last Updated: August 8, 2020

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EVZIO (AUTOINJECTOR) Drug Profile

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When do Evzio (autoinjector) patents expire, and what generic alternatives are available?

Evzio (autoinjector) is a drug marketed by Kaleo Inc and is included in one NDA. There are thirty patents protecting this drug.

This drug has one hundred and forty-three patent family members in fifteen countries.

The generic ingredient in EVZIO (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Evzio (autoinjector)

A generic version of EVZIO (AUTOINJECTOR) was approved as naloxone hydrochloride by HOSPIRA on September 24th, 1986.

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Drug patent expirations by year for EVZIO (AUTOINJECTOR)
Recent Clinical Trials for EVZIO (AUTOINJECTOR)

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Otsuka Pharmaceutical Co., Ltd.Phase 3
Zealand PharmaPhase 1
Miltenyi Biotec GmbHPhase 4

See all EVZIO (AUTOINJECTOR) clinical trials

Pharmacology for EVZIO (AUTOINJECTOR)
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

US Patents and Regulatory Information for EVZIO (AUTOINJECTOR)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for EVZIO (AUTOINJECTOR)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1685839 92292 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Johnson and Johnson
AstraZeneca
Moodys
Baxter

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