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.

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-nine 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:	21
Applicants:	1
NDAs:	1
Clinical Trials:	77
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
Nasus Pharma	PHASE1
Takeda	PHASE3
Viridian Therapeutics, Inc.	PHASE3

See all EVZIO (AUTOINJECTOR) clinical trials

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
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 (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	9,278,182
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016	9,737,669
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016	7,731,686
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016	8,608,698
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016	7,918,823
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016	10,314,977
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016	10,737,028

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
Canada	2825600	DISPOSITIFS D'ADMINISTRATION DE MEDICAMENT POUR L'ADMINISTRATION D'UN MEDICAMENT A L'INTERIEUR D'UNE SERINGUE PRE-REMPLIE (MEDICAMENT DELIVERY DEVICES FOR ADMINISTRATION OF A MEDICAMENT WITHIN A PREFILLED SYRINGE)

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

Last updated: June 15, 2026

EVZIO (Autoinjector) market dynamics and financial trajectory: price, volume, competition, and IP-driven risk

EVZIO (epinephrine) autoinjector is a niche, category-defined product with demand tied to emergency preparedness cycles, institutional formularies, and substitution risk from competing epinephrine autoinjectors and vended private-label channels. Financial trajectory is driven by (1) unit price versus payer rebates, (2) contract renewal and National/Regional account penetration (schools, workplace safety, long-term care), and (3) the durability of exclusivity and patent coverage around the device and product presentation, which impacts generic or “authorized” competitive launches.

The principal market variables for EVZIO are the number of eligibles for an epinephrine rescue product, the frequency of replacement cycles (expiry-driven), and the speed at which competitors gain formulary share across pediatric and adult dosing footprints.

Snapshot: what typically moves EVZIO revenue

• Sales drivers
  • Institutional and government purchasing (batch orders)
  • Replacement cadence driven by expiration date and inventory refresh
  • Manufacturer-funded contracting and formulary positioning
• Sales headwinds
  • Competitive substitution by alternative epinephrine autoinjectors with different pricing and supply terms
  • Payer-driven rebates and switch pressure at procurement renewal points
  • Device usability and training effectiveness perceptions that influence procurement decisions
• Core financial sensitivities
  • Unit volume is lumpy (contract-based) and renewal-dependent
  • Net sales track mostly with market access terms and replacement cycle timing
  • Gross margin is pressured by rebate intensity and channel mix

No reliable, complete financial dataset (EVZIO-specific historical net sales, gross margin, or operating income by year) is provided in the prompt; therefore no precise revenue trajectory figures are presented.

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What are the key market dynamics shaping EVZIO (epinephrine) autoinjector demand?

EVZIO sits in the epinephrine autoinjector market, where demand is shaped less by physician prescribing “today” and more by procurement, preparedness guidelines, and expiration-driven replacement. Unlike specialty injectable drugs, this category behaves like a medical device-adjacent pharmaceutical product with strong channel control dynamics.

Demand mechanics: who buys and why

• Institutional buyers: schools, workplaces, hospitality, correctional facilities, and long-term care often centralize purchasing.
• Retail consumers: families may buy after allergy diagnoses, then refresh due to expiry.
• Government contracts and disaster preparedness programs: can create sudden spikes but require competitive re-tendering.

Pricing and contracting: why net sales can diverge from list price

EVZIO revenue outcomes are highly sensitive to:

• Rebates tied to formulary placement
• Chargebacks and wholesaler terms
• Contract pricing floors and maximum allowable cost arrangements
• Competitive bidding at institutional level

Competitive forces that matter in epinephrine autoinjectors

• Device form factor and user interface
• Training materials and patient support
• Availability and supply reliability during shortage periods
• Pricing under multiple payer and procurement frameworks
• Dosing coverage in the product portfolio (pediatric vs adult dose coverage affects overall account share)

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How has EVZIO performed commercially versus competing epinephrine autoinjectors?

A precise head-to-head comparison requires at least one of: (1) EVZIO’s historical net sales, (2) market share by unit, or (3) payer/formulary share data. That information is not present in the prompt.

What can be stated with decision-grade specificity is how competitive dynamics typically play out in this segment:

Typical competitive displacement pattern

• Competitors that secure broad formulary inclusion can accelerate unit pull from institutions.
• Refill/expiry-driven cycles shift brand mix in bulk at reorder time.
• If a competitor offers a stronger pricing package or broader dosing coverage for an account, EVZIO can lose share even if clinical performance is considered equivalent.

What competitors tend to leverage

• Broad pharmacy access plus institution-friendly contracting
• Aggressive payer rebate offers where formulary switching is feasible
• Device usability claims that reduce training burden for non-clinical users

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When does EVZIO lose exclusivity and what does that mean for market entry risk?

Exclusivity and patent timelines are determinative for generic or “authorized” competitive exposure, but the prompt does not include EVZIO Orange Book listings, listed patents, or expiration dates. Without those data, no definitive exclusivity loss timeline can be produced.

How exclusivity affects pricing and unit volume

• Patent-protected exclusivity typically delays supply of substitutable versions, supporting higher negotiated net pricing.
• Once exclusivity gaps appear, procurement switches can be fast if a lower-cost equivalent is available.
• Device product line extensions, if protected, can slow the erosion of account-level spend.

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What patents protect EVZIO (autoinjector) and how strong is the estate?

A patent strength analysis requires:

• The EVZIO Orange Book entry
• Listed patents (composition, formulation/device, method-of-use if applicable)
• Expiration and terminal disclaimer information
• Litigation history and any settlement terms

None of these inputs appear in the prompt. As a result, a complete and accurate “what patents protect EVZIO” and “how strong is the patent estate” report cannot be generated without fabricating details.

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What is the Orange Book status of EVZIO and which patents are listed?

Orange Book status and listed patents are not provided in the prompt. Without the exact Orange Book entry and patent listing table, any attempt to enumerate patents would risk inaccuracy.

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Have there been Paragraph IV challenges or generic launch settlements for EVZIO?

Paragraph IV litigation and settlement terms are specific to the NDA/BLA and the patents listed in the Orange Book. The prompt does not include:

• Case captions/court dockets
• Filing dates of Paragraph IV certifications
• Settlement agreement dates
• Authorized generic arrangements

No reliable litigation-driven forecast can be made without those facts.

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How should EVZIO buyers think about FDA regulatory status and product lifecycle?

EVZIO’s regulatory profile matters operationally because autoinjector products are sensitive to labeling, device performance, and controlled distribution. However, the prompt does not provide:

• FDA approval date
• Supplemental approvals that might drive changes in device or dosing presentation
• Current manufacturing site approvals and any recent field actions
• Stability and shelf-life changes

So only the lifecycle logic can be asserted:

Lifecycle logic in epinephrine autoinjectors

• Renewal cycles for institutions hinge on shelf-life and availability
• Any manufacturing or packaging changes can affect procurement timelines
• Competitor supply stability can reshape market allocation decisions

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What formulation or device-related IP barriers could delay competition?

EVZIO is an autoinjector. Competitive entry risk typically turns on whether rivals can replicate:

• Device actuation mechanism
• Needle exposure and safety features
• Dosage delivery reliability
• Usability and training outcomes tied to labeling

But to map those barriers to enforceable rights, patent and regulatory documentation are required. The prompt does not supply them.

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What generic entry risks exist for EVZIO?

Generic entry risk depends on:

• Whether device and presentation are protected by enforceable patents
• Whether “equivalent” products can be approved under the relevant regulatory pathway
• Whether launch is delayed by litigation, settlement, or blocking patents

Because EVZIO-specific patent and exclusivity data are not present, generic entry risk cannot be quantified or scheduled in a factual way.

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How does EVZIO compare with other epinephrine autoinjectors on market access levers?

A fact-based comparison needs at least one of:

• Formulary tiering and formulary exclusion/inclusion history
• Net pricing spreads and rebate rates
• Coverage policies by large payers
• Contract pricing terms by institutional segments

Those items are not provided in the prompt. A decision-grade comparison cannot be executed without sourcing.

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Commercial trajectory map: what outcomes should drive EVZIO financial performance quarter to quarter?

In the absence of EVZIO’s numeric financial history, the most actionable approach is to define the operational KPI drivers that typically determine quarterly revenue for this category:

KPI drivers to monitor

• Purchase orders tied to school/workplace annual cycles
• Institutional contract renewals (win/loss)
• Wholesaler inventory and reorder velocity
• Expiry replacement sell-through
• Supply continuity and allocation
• Net price realization versus list price

Outcome scenarios that usually move revenue

• Win a multi-site institutional contract: revenue spikes, then normalizes into refill flows
• Lose formulary placement or switch at renewal: volume declines at the account level, often without immediate substitute switching everywhere
• Supply disruption: tends to create a temporary dip plus a later catch-up effect if demand is prepaid or institutional inventory is managed

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Key Takeaways

• EVZIO’s market dynamics are dominated by institutional procurement, pharmacy access terms, and expiry-driven replacement cycles rather than ongoing prescription growth.
• Financial trajectory is largely a function of net pricing realization (rebates, chargebacks, contract terms), contract renewal timing, and substitution speed by competing epinephrine autoinjectors.
• A complete, accurate exclusivity timeline, Orange Book patent list, litigation map (Paragraph IV/settlements), and patent strength assessment cannot be produced from the information provided.

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FAQs

1. What procurement cycles most influence autoinjector sales like EVZIO?
   Institutional ordering cycles (school year, workplace compliance schedules) and expiry-driven reorders drive demand spikes.

2. How do rebates and chargebacks typically affect EVZIO’s reported net sales?
   Net sales can move materially below list price as contracts and formulary rebates shift with competitor presence.

3. What information determines whether an EVZIO generic can launch?
   Orange Book exclusivity and listed patents, plus any blocking patents and litigation/settlement outcomes.

4. Do autoinjector demand patterns depend more on patient diagnosis or institutional policy?
   Both matter, but institutional procurement and replacement cycles often dominate unit movement over short horizons.

5. What operational signals indicate EVZIO revenue momentum or risk?
   Contract wins/losses, inventory reorder velocity at wholesalers, supply continuity, and shelf-life sell-through behavior.

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
2. FDA Drug Approval and Program Information (drug labeling and regulatory history). (Accessed via FDA database).