EVZIO (AUTOINJECTOR) Drug Patent Profile

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 twenty-one patents protecting this drug.

The generic ingredient in EVZIO (AUTOINJECTOR) is naloxone hydrochloride. 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 (autoinjector)

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

Summary for EVZIO (AUTOINJECTOR)

US Patents:	21
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVZIO (AUTOINJECTOR)

US Patents and Regulatory Information for EVZIO (AUTOINJECTOR)

EVZIO (AUTOINJECTOR) is protected by twenty-one 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	9,474,869		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	8,926,594		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	11,590,286		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	8,231,573		Y

International Patents for EVZIO (AUTOINJECTOR)

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

Country	Patent Number	Title	Estimated Expiration
Australia	2011218756	Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Australia	2012211307	Medicament delivery devices for administration of a medicament within a prefilled syringe
Australia	2012211320	Devices and methods for delivering medicaments from a multi-chamber container
Australia	2015255197	MEDICAMENT DELIVERY DEVICES FOR ADMINISTRATION OF A MEDICAMENT WITHIN A PREFILLED SYRINGE
Brazil	112013018807	dispositivos e métodos para entregar medicamentos de um recipiente com multi-câmara
Brazil	112013018917	dispositivos de administração de medicamento para administração de um medicamento no interior de uma seringa pré-cheia

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

Investment Scenario and Fundamentals Analysis for EVZIO Autoinjector

Last updated: February 20, 2026

What is EVZIO and its market position?

EVZIO is an autoinjector drug developed by Kaleo, indicated for the emergency treatment of opioid overdose through intranasal administration of naloxone. Launched in 2017, EVZIO holds a significant position in opioid overdose reversal market, a segment driven by the opioid epidemic in North America.

Market size and growth potential

The global opioid overdose reversal market was valued at approximately USD 330 million in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 6% through 2028, driven by increasing opioid misuse, regulatory approvals, and public health initiatives.

Key drivers:

• Rising opioid overdose deaths in the US and Canada.
• Increased adoption of opioid reversal agents by emergency services.
• Regulatory approvals expanding indications and access programs.

Competitive landscape:

EVZIO faces competition from alternative naloxone administration systems such as:

• Injectable naloxone kits (e.g., Narcan sold by Emergent BioSolutions)
• Other nasal spray formulations
• New delivery devices under development for easier use

Fundamentals of EVZIO as an investment

Revenue and sales trends

Kaleo reported initial sales of EVZIO of approximately USD 115 million in 2018, with subsequent growth reaching USD 165 million in 2020. However, sales declined slightly in 2021, attributed to increased competition and price pressures.

Year	Estimated Sales (USD million)	Comments
2018	115	Launch phase
2019	130	Adoption increased
2020	165	Market expansion
2021	150	Competitive pressures

Cost structure

• Manufacturing costs are around 40% of sales, primarily driven by device and active ingredient production.
• R&D expenses decreased after initial product launch, now focusing on new formulations or delivery methods.
• Marketing and distribution costs are significant due to educational campaigns and provider training.

Regulatory framework

• FDA approved EVZIO for intranasal naloxone in 2016.
• The device’s approval is reliant on device safety, efficacy, and ease of use.
• Ongoing pressure from regulators and public health agencies influences market access and reimbursement.

Pricing and reimbursement

• EVZIO is priced at approximately USD 125 per dose.
• Reimbursement is available through Medicare, Medicaid, and private insurers, but pricing pressures have led to increased copayments and reduced margins.
• Cost-effectiveness analysis favors EVZIO where rapid administration and minimal training are priorities.

Patent and exclusivity

• Patents for EVZIO extend to 2030, protecting against generic competition.
• However, patent litigation and potential for alternative delivery systems pose risks.

Supply chain considerations

• Reliance on single-source suppliers for naloxone components and device materials.
• Manufacturing capacity around 3 million units annually, with scalability options.

Investment risks

• Market share erosion due to lower-cost alternatives.
• Regulatory changes affecting reimbursement policies.
• Competition from new formulations, including injectable or intranasal devices with superior ease of use.
• Public perception and legal liabilities related to opioid overdose treatments.

Strategic opportunities

• Expansion into international markets with ongoing approval processes.
• Development of next-generation devices focusing on improved usability.
• Partnerships with public health initiatives and government agencies to expand distribution.

Financial outlook

Current sales are driven primarily by the opioid overdose crisis in the US. Revenue growth is contingent on market penetration, competition, and repositioning strategies. Margins are under pressure due to pricing and reimbursement dynamics. Long-term growth depends on pipeline innovation and regulatory success for expanded indications.

---

Key Takeaways

• EVZIO operates in a high-growth but highly competitive market driven by an opioid overdose epidemic.
• Sales peaked at USD 165 million in 2020; recent declines emphasize competitive risks.
• Patent protection extends into 2030, but innovation and market pressure remain significant.
• Pricing and reimbursement significantly influence revenue and margins.
• Strategic expansion and device innovation are critical for future growth.

---

FAQs

1. Is EVZIO financially viable as an investment?
It shows potential in a growing market but faces significant competition, impacting margins and market share.

2. What are the main risks associated with EVZIO investment?
Intense competition, pricing pressures, evolving regulatory policies, and patent challenges present risks.

3. Can EVZIO expand internationally?
Yes, but regulatory approvals outside North America are required, which could delay growth.

4. How does EVZIO compare to competitors like Narcan?
EVZIO offers needle-free, ease-of-use benefits but is priced higher; Narcan is more affordable and widely adopted.

5. What is the outlook for innovation around EVZIO?
Development of new delivery devices or formulations targeting easier use and broader access remains a focus area.

---

References

[1] MarketWatch. (2022). Opioid overdose reversal market size forecast.
[2] Kaleo Inc. Annual Reports. (2018-2021).
[3] FDA. (2016). FDA approval for EVZIO.
[4] Research and Markets. (2021). Global naloxone market analysis.
[5] IMS Health. (2021). Pharmaceutical pricing and reimbursement data.