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 twenty-five 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-eight 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:	24
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	49
Patent Applications:	2,432
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 twenty-four 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	10,335,549		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	8,016,788		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	8,226,610		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	10,143,792
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	7,749,194		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	8,608,698
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	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	2791286
Brazil	112013018807	dispositivos e métodos para entregar medicamentos de um recipiente com multi-câmara
Australia	2004325202
Canada	2825637	DISPOSITIFS ET PROCEDES PERMETTANT DE FOURNIR DES MEDICAMENTS A PARTIR D'UN RECIPIENT A CHAMBRES MULTIPLES (DEVICES AND METHODS FOR DELIVERING MEDICAMENTS FROM A MULTI-CHAMBER CONTAINER)
Australia	2012211320	Devices and methods for delivering medicaments from a multi-chamber container

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EVZIO

Last updated: July 27, 2025

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Introduction

EVZIO (naloxone auto-injector) stands as a pivotal pharmaceutical product targeting opioid overdose reversal. Developed by Teva Pharmaceutical Industries, EVZIO was approved by the FDA in 2016 and has significantly contributed to the global effort to combat the opioid crisis. Understanding the market dynamics and financial trajectory surrounding EVZIO provides critical insights into not only its commercial performance but also into broader healthcare and policy trends influencing the opioid overdose response landscape.

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Market Overview and Penetration

The rising prevalence of opioid use disorder (OUD) and overdose fatalities drive the demand for naloxone-based interventions like EVZIO. According to the CDC, nearly 107,000 Americans died from drug overdoses in 2021, with opioids involved in over 75% of these deaths. This heightened awareness and policy initiatives favoring naloxone distribution have expanded utilization, especially among first responders and community organizations.

EVZIO's initial market positioned it predominantly within hospitals, clinics, and emergency response units. Subsequently, the product penetrated outpatient clinics and community programs, especially following FDA approval for over-the-counter (OTC) access in 2019, which marked a significant catalyst for market expansion.

Competitive Landscape

While EVZIO introduced an easy-to-administer auto-injector format, it faces competition from multiple naloxone products. Generic naloxone injectables and nasal spray formulations (e.g., Narcan/Narcan Nasal Spray) launched at lower prices, intensifying price competition. The nasal spray formulations, notably Narcan, gained popularity due to their ease of use, lower cost, and OTC availability, threatening EVZIO's market share.

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Regulatory and Policy Influences

FDA Approvals and Over-the-Counter Accessibility

In 2019, the FDA approved EVZIO for OTC sales, marking a strategic shift to improve accessibility amid ongoing opioid overdose crises. This move facilitated broader community-based availability, especially in high-risk settings. However, OTC status also introduced pricing pressures, as insurers and public health programs aimed for affordable expansion.

Government and Public Funding

Government programs, including Medicaid and community health initiatives, have subsidized naloxone distribution, favoring accessible formulations like EVZIO. The U.S. Department of Health and Human Services allocated funds for naloxone distribution, further supporting market growth.

Legislative Landscape

State-level legislation increasingly mandates naloxone availability, especially in high-risk areas such as prisons, schools, and pharmacies. These policies collectively foster a conducive environment for EVZIO’s uptake, although price sensitivity remains a challenge.

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Financial Trajectory and Commercial Performance

Revenue Evolution

Since its launch, EVZIO's revenue trajectory experienced initial growth driven by emergency response needs and policy support. However, this progress faced hurdles due to high drug costs and competitive pressure.

Pricing Strategy and Cost Dynamics

EVZIO’s premium price point—approximately $430 per unit at launch—limped its market penetration amidst the rise of lower-cost alternatives. Despite pricing reductions and discounts, the product’s profitability has been tested. The introduction of generics and nasal formulations has further compressed margins.

Insurance and Reimbursement

Insurance coverage plays a critical role in EVZIO’s financial performance. While Medicaid and Medicare provide reimbursement pathways, high out-of-pocket costs for patients can impede access. Reimbursement policies have been evolving, with recent initiatives aiming to improve affordability.

Market Share and Sales Trends

Teva reported modest sales figures initially, with a plateau emerging as competitors expanded. In recent years, EVZIO's market share declined marginally due to multiple factors, including increased nasal spray competition, OTC availability, and changing prescribing behaviors.

Impact of COVID-19

The pandemic disrupted healthcare service delivery, affecting distribution channels and emergency response operations. Conversely, increased overdose incidents during COVID-19 heightened demand for naloxone, including EVZIO, providing a temporary boost to sales.

Future Financial Outlook

The financial trajectory hinges on factors including:

• Policy initiatives expanding access and distribution.
• Price competition with generics and nasal formulations.
• Innovation in delivery systems and formulation improvements.
• Potential patent expirations and generic entries.

Analysts expect revenue stabilization if EVZIO maintains a niche among high-risk and controlled settings, but widespread adoption may favor more cost-effective alternatives.

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Market Drivers and Challenges

Drivers

• Global and national opioid overdose crises energize demand.
• Legislative mandates for naloxone availability.
• Increasing awareness and destigmatization of drug addiction.
• Efforts to expand OTC access to improve community distribution.

Challenges

• Pricing pressures from generics and nasal sprays.
• Insufficient reimbursement and high patient out-of-pocket costs.
• Competition from newer, user-friendly formulations.
• Patent expirations and potential generic proliferation.

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Strategic Implications

Manufacturers aiming to sustain EVZIO’s market relevance must adapt by:

• Innovating delivery mechanisms to improve ease of use.
• Collaborating with public health authorities to subsidize costs.
• Strengthening insurance reimbursement pathways.
• Engaging in targeted marketing within high-risk populations.

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Key Takeaways

• The rising tide of opioid overdoses propels demand for naloxone products like EVZIO, but market growth is constrained by competition and pricing pressures.
• Policy initiatives, including OTC approval and government funding, facilitate broader access but challenge profit margins.
• EVZIO’s financial trajectory is marked by initial growth, stabilization, and potential decline due to lower-cost alternatives and patent expirations.
• Sustainable profitability relies on innovation, strategic partnerships, and navigating reimbursement landscapes.
• The future of EVZIO’s commercial success depends on balancing accessibility with affordability amidst a highly competitive environment.

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FAQs

1. What has been the primary factor influencing EVZIO’s market penetration?
The primary factor is the increasing demand driven by the opioid overdose epidemic, coupled with regulatory policies expanding access, notably the FDA’s OTC approval in 2019.

2. How has competition from generic naloxone products affected EVZIO's sales?
Generic injectables and nasal sprays offer lower-cost alternatives, reducing EVZIO’s market share and pressuring profit margins, especially as the product remains premium-priced.

3. What role does insurance reimbursement play in EVZIO's financial performance?
Reimbursement is crucial; full coverage enables broader access, whereas high out-of-pocket costs deter use. Changes in reimbursement policy directly impact sales volume and profitability.

4. What future developments could impact EVZIO’s financial trajectory?
Potential patent expirations, new formulations, strategic partnerships, and policy changes (e.g., increased funding for overdose prevention) could redefine EVZIO’s market positioning.

5. Can EVZIO sustain its market presence amid rising nasal spray popularity?
Sustaining relevance requires continued innovation, positioning as a high-risk or hospital-grade product, and aligning with public health initiatives to retain niche efficacy.

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References

[1] Centers for Disease Control and Prevention. (2022). Drug Overdose Deaths.
[2] U.S. Food and Drug Administration. (2019). FDA Approves First Over-the-Counter Naloxone Product.
[3] Teva Pharmaceuticals. (2022). Annual Financial Reports.
[4] MarketsandMarkets. (2021). Opioid Overdose Antidotes Market.
[5] Drug Topics. (2022). Naloxone Market Dynamics and Future Outlook.

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This comprehensive analysis provides business professionals with an actionable understanding of EVZIO’s market environment and financial prospects. A nuanced appreciation of policy, competition, and demand factors informs strategic decision-making in the evolving opioid overdose reversal landscape.