EVZIO Drug Patent Profile

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

Evzio is a drug marketed by Kaleo Inc and is included in two NDAs. There are twenty-two 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. Fifty 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:	21
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVZIO

US Patents and Regulatory Information for EVZIO

EVZIO 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	8,231,573		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	8,021,344		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	11,590,286		Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	7,749,194		Y

International Patents for EVZIO

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	201105021
Australia	2012211307	Medicament delivery devices for administration of a medicament within a prefilled syringe
United Kingdom	2491283
World Intellectual Property Organization (WIPO)	2017124572
Canada	2926365	DISPOSITIFS, SYSTEMES ET PROCEDES POUR L'ADMINISTRATION DE MEDICAMENTS (DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY)

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 Investment Analysis: Market Position, Fundamentals, and Outlook

Last updated: February 3, 2026

Overview

EVZIO (naloxone auto-injector), developed by Kaleo Pharmaceuticals, is a pre-filled auto-injector designed for rapid opioid overdose reversal. Approved by the FDA in 2016, EVZIO faces an evolving market driven by the opioid crisis, regulatory landscape shifts, and competition from alternative naloxone products.

Market Environment

• The U.S. opioid overdose mortality increased from approximately 47,600 in 2017 to over 80,000 in 2020, indicating a persistent public health crisis.[1]
• Multiple federal and state-level initiatives support naloxone distribution, including over-the-counter access in certain states and federal programs like the Public Health Emergency (PHE) declarations.
• Market size: In 2022, the U.S. naloxone market valued approximately $1.4 billion; projected to grow at a CAGR of 6% through 2030.[2]

Product Positioning and Competitive Landscape

• EVZIO's strengths include ease of use for laypersons, FDA approval for community administration, and pre-dose safety.
• Competition mainly involves syringe-based naloxone (e.g., Narcan nasal spray) and generic auto-injectors.
• Challenges include higher price compared to generics ($4 per dose for Narcan nasal spray vs. ~$120 for EVZIO), limiting widespread adoption outside emergency responders and healthcare providers.

Key Fundamentals

Metric	2022	Comments
Revenue	~$80 million	Declining since peak of $120M in 2018, impacted by generics & competition
Gross Margin	Approx. 50%	Lower compared to peers due to manufacturing costs and pricing pressure
R&D Spending	~$10 million	Focuses on new formulations and expanding indications
Operating Expenses	~$50 million	Includes marketing, sales, and regulatory costs
Cash and Equivalents	~$200 million	Sufficient to fund operations through 2024
EBITDA Margin	-20%	Ongoing investments in market expansion and pipeline

Financial Outlook and Challenges

• Revenue plateau: EVZIO's sales are constrained by high pricing and limited insurance reimbursement in some markets.
• Market penetration: Growth heavily relies on increased awareness, expanded distribution channels, and favorable reimbursement policies.
• Competition from Narcan nasal spray, which prices at lower levels, is intensifying the pressure.
• Future prospects depend on licensing agreements, pipeline expansion, and regulatory approvals for new formulations or indications.

Regulatory and Reimbursement Dynamics

• The FDA's approval of generic naloxone auto-injectors provides pricing pressure but also expands access.
• Medicare and Medicaid coverage is widespread, but reimbursement rates may influence physician and pharmacy stocking.
• Legislative mandates in multiple states aim to require naloxone availability, potentially increasing demand.

Strategic Opportunities and Risks

Opportunities:

• Expansion into international markets where opioid overdose is a growing concern.
• Development of next-generation auto-injectors or combinations addressing other substance overdoses.
• Collaborations with public health programs to increase distribution, possibly subsidized to reduce costs.

Risks:

• Price erosion due to generics and biosimilars.
• Policy shifts decreasing funding or restricting distribution.
• Market saturation, especially in emergency and community settings.

Valuation Considerations

• EVZIO's valuation remains speculative, heavily influenced by the company's ability to sustain or grow sales in a competitive environment.
• Comparable analysis suggests a market cap in the range of $200–300 million, reflecting declining sales and high R&D costs.
• Potential upside hinges on pipeline success, new indications, and regulatory landscape changes.

Conclusion

Investments in EVZIO involve significant exposure to public health policy, pricing dynamics, and market competition. While the company's product meets critical needs, market growth prospects for EVZIO alone are limited barring substantial strategic shifts or pipeline advancements. The firm's financial health is sound but constrained by declining revenues and aggressive competitors.

---

Key Takeaways

• EVZIO's market is constrained by high price and competition from lower-cost naloxone alternatives.
• The company’s revenue has declined from its peak, with limited growth prospects in current form.
• Market growth depends on expanded access, reimbursement policies, and pipeline development.
• Competitive pressure from generics is intensifying, threatening future margins.
• Strategic partnerships and pipeline innovations are essential for sustained value.

---

FAQs

1. What determines EVZIO’s market potential?
Market potential depends on opioid overdose rates, legislative mandates, reimbursement policies, and competition from lower-cost alternatives like Narcan. Growth is limited if pricing and access do not improve.

2. How does EVZIO compare financially to competitors?
Compared to Narcan nasal spray, EVZIO is more expensive (~$120 vs. ~$4), limiting its adoption primarily to healthcare settings and EMS. Margins are compressed due to pricing and cost structure.

3. What are the key regulatory risks?
Potential regulatory changes could alter reimbursement policies, restrict marketing claims, or facilitate the entry of new generics, impacting sales and margins.

4. What growth avenues exist for EVZIO?
Expanding into international markets, developing new formulations, and partnering with public health initiatives for subsidized distribution are potential growth pathways.

5. What financial indicators should investors monitor?
Track revenue trends, gross margins, R&D expenditure, reimbursement policies, competitive launches, and pipeline updates for next-generation products.

---

References

1. CDC, "Opioid Overdose Deaths," 2022.
2. MarketsandMarkets, "Naloxone Market," 2022.