EVZIO Drug Patent Profile

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

Evzio is a drug marketed by Kaleo Inc and is included in two NDAs. There are thirty-four patents protecting this drug.

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

The generic ingredient in EVZIO 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

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

Summary for EVZIO

International Patents:	143
US Patents:	33
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	56
Patent Applications:	1,772
Drug Prices:	Drug price information for EVZIO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVZIO
What excipients (inactive ingredients) are in EVZIO?	EVZIO excipients list
DailyMed Link:	EVZIO at DailyMed

See drug prices for EVZIO

US Patents and Regulatory Information for EVZIO

EVZIO 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	8,016,788		Y
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014		DISCN	Yes	No	8,627,816		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	7,918,823		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	10,314,977		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	8,206,360		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	7,731,690		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	8,627,816		Y

Expired US Patents for EVZIO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	8,361,029
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	9,737,669
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	10,314,977
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	8,608,698
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	8,425,462
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	8,313,466
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	7,918,823

International Patents for EVZIO

See the table below for patents covering EVZIO around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2891057
United Kingdom	2434548
Israel	184552	התקן למתן תרופות (Apparatus for medicament delivery)
Brazil	112013018807	dispositivos e métodos para entregar medicamentos de um recipiente com multi-câmara
Australia	2012201481	Devices, systems, and methods for medicament delivery
European Patent Office	1843812
Japan	5653345

Supplementary Protection Certificates for EVZIO

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Evzio

Introduction

Evzio, a naloxone auto-injector developed by Kaleo, Inc., has been a significant player in the market for opioid overdose reversal since its introduction in 2014. This article delves into the market dynamics and financial trajectory of Evzio, highlighting its impact, pricing controversies, and market performance.

Market Entry and Initial Success

Evzio entered the market in 2014 as the first naloxone product approved for use by laypersons to reverse opioid overdoses. It quickly captured a substantial market share, with 34% of the total market in its first year and growing to 53% of the insured market by 2015[1].

Pricing and Cost Implications

One of the most contentious aspects of Evzio has been its pricing. Initially set at $575, the price was later increased dramatically, reaching over $4,000 per dose. This pricing strategy was criticized for being exploitative, especially given that the actual cost of naloxone itself is minimal, estimated to be as low as a nickel per dose[2].

Out-of-Pocket Costs

The out-of-pocket costs for Evzio have been significantly higher for uninsured patients compared to those with insurance. In 2016, the mean out-of-pocket cost for Evzio among uninsured patients was $2,136.37, a 2,429% increase from 2015. This contrasts sharply with the costs of generic naloxone and Narcan, which were substantially lower[1].

Impact of Competition

The introduction of Narcan in 2016 marked a significant shift in the market dynamics. Narcan quickly captured 41% of the insured market and 30% of the uninsured market, leading to a decline in Evzio's market share to 27% and 11%, respectively[1].

Revenue Streams and Medicare

Despite the high pricing, Kaleo's revenue for Evzio has been largely driven by Medicare. A Senate report revealed that Kaleo ensured doctors signed forms indicating Evzio was medically necessary, leading Medicare to cover the device at near full price. This resulted in over $142 million in charges to taxpayers over four years[2].

Clinical and Safety Profile

Evzio was approved based on bioavailability data referencing the safety and effectiveness of Narcan, an injectable naloxone formulation approved in 1971. The 2 mg strength of Evzio was later approved, offering higher exposures to naloxone compared to the 0.4 mg intramuscular injection. Clinical trials showed no serious adverse events or deaths, with mild erythema being the most frequently reported side effect[3].

Market Growth and Projections

The naloxone market, which includes Evzio, is expected to grow significantly. The market is projected to increase from $1,341.5 million in 2024 to $2,683.9 million by 2031, with a compound annual growth rate (CAGR) of 10.4%. This growth is driven by the increasing prevalence of opioid overdoses and favorable government policies aimed at increasing naloxone availability[4].

Regional Market Dominance

North America, particularly the U.S., represents the largest market for naloxone, with 43.8% of the market share in 2024. The region's high demand is due to the opioid epidemic and government initiatives to expand access to naloxone. Most healthcare plans in the U.S. provide coverage for naloxone, making it more accessible[4].

Challenges and Controversies

Evzio's high pricing has been a major controversy, with accusations that Kaleo exploits the opioid crisis and burdens taxpayers. The company's strategy of ensuring Medicare coverage has been particularly criticized. Additionally, the cumbersome paperwork required for prescriptions has been a barrier to wider adoption[2].

Industry Players and Competition

The naloxone market is competitive, with several key players including Emergent, Indivior PLC, Akorn, Inc., and Hikma Pharmaceuticals PLC, among others. The presence of generic and branded products has kept the market dynamic, with each player vying for market share through pricing strategies and distribution networks[4].

Government Policies and Public Awareness

Government policies and public awareness campaigns have significantly influenced the demand for naloxone. Many states and municipalities now recommend or require naloxone to be co-prescribed with opioid prescriptions, driving up demand and ensuring wider availability[4].

Financial Performance and Profitability

Despite the high revenue generated from Medicare, Kaleo has reported that it lost money in the first four years of bringing Evzio to the market. However, the company has emphasized the lifesaving impact of the product and its evolving business model[2].

Key Takeaways

• Market Entry and Success: Evzio quickly captured a significant market share upon its introduction.
• Pricing Controversies: High pricing has been a major issue, with significant out-of-pocket costs for uninsured patients.
• Competition: The introduction of Narcan led to a decline in Evzio's market share.
• Revenue Streams: Medicare has been a major revenue source for Evzio.
• Market Growth: The naloxone market is expected to grow significantly due to the opioid epidemic and favorable government policies.
• Challenges: High pricing and cumbersome paperwork have been significant challenges.

FAQs

1. What is Evzio and how does it work? Evzio is a naloxone auto-injector designed to reverse opioid overdoses. It is easy to use by laypersons and provides a talking guide to assist in the administration process.

2. Why is Evzio so expensive? The high price of Evzio, over $4,000 per dose, has been criticized as exploitative. The actual cost of naloxone is minimal, but the auto-injector's pricing includes development, marketing, and other costs.

3. How has competition affected Evzio's market share? The introduction of Narcan in 2016 significantly reduced Evzio's market share, as Narcan captured a substantial portion of both the insured and uninsured markets.

4. What role has Medicare played in Evzio's revenue? Medicare has been a major revenue source for Evzio, with Kaleo ensuring that doctors signed forms indicating the device was medically necessary, leading to near full price coverage by Medicare.

5. What are the future projections for the naloxone market? The naloxone market is expected to grow from $1,341.5 million in 2024 to $2,683.9 million by 2031, driven by the increasing prevalence of opioid overdoses and favorable government policies.

Sources

1. JAMA Health Forum: "Out-of-Pocket Costs for Naloxone by Drug Brand and Payer in the United States, 2010-2018"[1].
2. CBS News: "Evzio: The overdose-reversal drug with a $4000+ price tag"[2].
3. FDA: "Supplemental New Drug Application for Evzio"[3].
4. Coherent Market Insights: "Naloxone Market Size & Share Analysis - Industry Research Report"[4].