EVZIO (AUTOINJECTOR) Drug Patent Profile

Which patents cover Evzio (autoinjector), and when can generic versions of Evzio (autoinjector) launch?

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

This drug has one hundred and forty-one 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. Forty-five suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evzio (autoinjector)

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

Summary for EVZIO (AUTOINJECTOR)

International Patents:	141
US Patents:	33
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	63
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVZIO (AUTOINJECTOR)
DailyMed Link:	EVZIO (AUTOINJECTOR) at DailyMed

Recent Clinical Trials for EVZIO (AUTOINJECTOR)

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

Sponsor	Phase
scPharmaceuticals, Inc.	Phase 1
Ionis Pharmaceuticals, Inc.	Phase 1
CSL Behring	Phase 1

See all EVZIO (AUTOINJECTOR) clinical trials

Pharmacology for EVZIO (AUTOINJECTOR)

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

US Patents and Regulatory Information for EVZIO (AUTOINJECTOR)

EVZIO (AUTOINJECTOR) is protected by thirty-three US patents.

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		DISCN	Yes	No			Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No			Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No			Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No			Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No			Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No			Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No			Y

Expired US Patents for EVZIO (AUTOINJECTOR)

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
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016

International Patents for EVZIO (AUTOINJECTOR)

See the table below for patents covering EVZIO (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	227617
World Intellectual Property Organization (WIPO)	2006057636
Canada	2926365
Australia	2006210865
Mexico	340676
United Kingdom	2449027	Devices, systems and methods for medicament delivery
Canada	2825637

Supplementary Protection Certificates for EVZIO (AUTOINJECTOR)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg		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

EVZIO (AUTOINJECTOR) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EVZIO (Autoinjector)

Introduction

EVZIO, a naloxone hydrochloride auto-injector, was approved by the FDA on April 3, 2014, for the emergency treatment of known or suspected opioid overdose. This article delves into the market dynamics and financial trajectory of EVZIO, highlighting its development, pricing strategies, financial transactions, and eventual discontinuation.

Development and Approval

EVZIO was developed by kaléo (formerly Intelliject) and is a single-use, pre-filled auto-injector designed for subcutaneous or intramuscular injection. It is notable for its voice and visual guidance, which assists users in administering the drug correctly[3][5].

Market Entry and Pricing

Upon its approval, EVZIO entered a market in dire need of effective opioid overdose reversal agents. Initially, the product was priced at a level that made it accessible to some, but not all, potential users. To address affordability concerns, kaléo introduced an authorized generic version of EVZIO at a reduced list price of $178 per carton (containing two auto-injectors), significantly lower than the branded version. This move was aimed at improving access for Medicare Part D patients and other groups facing cost barriers[1].

Financial Transactions and Funding

kaléo secured significant funding to support the commercialization of EVZIO. In 2014, the company entered into a $150 million debt financing agreement with PDL BioPharma. This financing was backed by royalty payments from kaléo's first product, Auvi-Q, and a portion of the net sales of EVZIO. The funds were used to repay existing debt, support the commercialization of EVZIO, and invest in the development of other pipeline products[2][5].

Market Impact and Access

The introduction of EVZIO and its authorized generic had a positive impact on market access. The lower-priced generic option helped reduce barriers to access, particularly for Medicare Part D patients. kaléo worked with pharmacy benefit managers and insurers to ensure broader coverage and affordability[1].

Clinical and Safety Profile

EVZIO demonstrated a strong clinical and safety profile. The FDA approval was based on bioavailability data that showed the product's efficacy in reversing opioid overdose symptoms. Clinical trials indicated that EVZIO was safe and effective, with minimal adverse events reported[3].

Discontinuation

Despite its clinical and market significance, EVZIO and its authorized generic were discontinued from the market in 2020. kaléo notified the FDA, and the products were no longer available for future refills, although existing stock could still be dispensed until expiration. This decision had implications for workers’ compensation and auto no-fault insurance, prompting the consideration of alternative naloxone treatments like Narcan Nasal Spray[4].

Impact on Workers’ Compensation and Auto No-Fault

The discontinuation of EVZIO required prescribers to review and adjust medication therapies for patients who had been using the auto-injector. Alternative treatments, such as Narcan Nasal Spray, became more prominent due to their lower cost and ease of administration. This transition had a minimal impact on Optum's book of business but necessitated updates to their treatment protocols and pricing databases[4].

Financial Trajectory

The financial trajectory of EVZIO was marked by significant investment and revenue generation. The $150 million financing from PDL BioPharma was crucial for commercialization and product development. However, the eventual discontinuation of the product suggests that despite initial financial support and market entry, the product did not achieve long-term sustainability in the market.

Key Takeaways

• Development and Approval: EVZIO was approved by the FDA in 2014 as a single-use auto-injector for opioid overdose reversal.
• Pricing Strategies: An authorized generic was introduced at a lower price to improve access.
• Financial Transactions: kaléo secured $150 million in financing from PDL BioPharma to support commercialization and product development.
• Market Impact: The product improved access to opioid overdose reversal agents but was eventually discontinued.
• Clinical and Safety Profile: EVZIO demonstrated a strong clinical and safety profile.
• Discontinuation: The product was discontinued in 2020, necessitating the use of alternative treatments.

FAQs

What was the primary use of EVZIO?

EVZIO was used for the emergency treatment of known or suspected opioid overdose, specifically to reverse life-threatening respiratory depression.

Why was an authorized generic version of EVZIO introduced?

The authorized generic version was introduced to provide a more affordable option, particularly for Medicare Part D patients, and to improve access to the medication.

What financial support did kaléo receive for EVZIO?

kaléo received $150 million in debt financing from PDL BioPharma, backed by royalty payments and a portion of the net sales of EVZIO.

Why was EVZIO discontinued?

EVZIO and its authorized generic were discontinued in 2020, although the exact reasons are not specified, it likely involved market and financial considerations.

What alternatives are available for opioid overdose reversal after the discontinuation of EVZIO?

Alternatives include Narcan Nasal Spray, which is commonly prescribed due to its low cost and ease of administration, and other naloxone solutions for injection.

Sources

1. Authorized Generic for EVZIO® (naloxone HCl injection) to be available at a reduced list price of $178. Biospace.
2. PDL BioPharma Completes $150 Million Financing Transaction with kaleo. PDL BioPharma.
3. Summary Review for EVZIO (naloxone hydrochloride). FDA.
4. Evzio auto-injector and its generic equivalent have been discontinued. Optum.
5. Kaleo Announces $150 Million Debt Financing To Support Commercialization of EVZIO and Development of Pipeline Products. Biospace.