NALOXONE HYDROCHLORIDE (AUTOINJECTOR) Drug Patent Profile

Which patents cover Naloxone Hydrochloride (autoinjector), and when can generic versions of Naloxone Hydrochloride (autoinjector) launch?

Naloxone Hydrochloride (autoinjector) is a drug marketed by Kaleo Inc and is included in one NDA. There are six patents protecting this drug.

This drug has thirty-five patent family members in ten countries.

The generic ingredient in NALOXONE HYDROCHLORIDE (AUTOINJECTOR) 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 Naloxone Hydrochloride (autoinjector)

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

Summary for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

International Patents:	35
US Patents:	6
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

US Patents and Regulatory Information for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

NALOXONE HYDROCHLORIDE (AUTOINJECTOR) is protected by six 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	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	10,322,239
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	8,939,943		Y
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	10,143,792
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	9,474,869		Y
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	9,814,838		Y
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	9,022,022		Y

International Patents for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

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

Country	Patent Number	Title	Estimated Expiration
Israel	227617	מכשיר להעברת תרופה לצורך מתן תרופה בתוך מזרק שמולא מראש (Medicament delivery devices for administration of a medicament within a prefilled syringe)
Israel	183247	DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY
European Patent Office	2099434	DISPOSITIFS ET SYSTÈMES POUR L'ADMINISTRATION DE MÉDICAMENTS (DEVICES AND SYSTEMS FOR MEDICAMENT DELIVERY)
Australia	2012211307	Medicament delivery devices for administration of a medicament within a prefilled syringe
Mexico	2013008614	DISPOSITIVOS Y METODOS PARA ADMINISTRAR MEDICAMENTOS DE UN RECIPIENTE DE MULTIPLES CAMARAS. (DEVICES AND METHODS FOR DELIVERING MEDICAMENTS FROM A MULTI-CHAMBER CONTAINER.)
Canada	3029371	APPAREILS, SYSTEMES ET METHODES POUR ADMINISTRATION D'UN MEDICAMENT (DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY)

Supplementary Protection Certificates for NALOXONE HYDROCHLORIDE (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

Naloxone Hydrochloride (Autoinjector): Investment Scenario and Fundamentals Analysis

Last updated: April 24, 2026

What product is “naloxone hydrochloride (autoinjector)” and what does the market price?

Naloxone hydrochloride (autoinjector) is an opioid antagonist used to reverse opioid-induced respiratory depression. Investment-grade evaluation hinges on two variables: (1) payer and government procurement volumes driven by overdose policy and prescribing mandates, and (2) launch-to-launch competitive intensity from alternative naloxone formats (nasal spray and other injector designs) and generic price compression in autoinjector segments.

Core commercialization facts that drive revenue durability

• Target setting: Public health and acute care settings (EMS, police, schools, workplaces), plus home use for caregiver/at-risk patient programs.
• Procurement pattern: Bulk purchasing by government agencies and health systems often locks in multi-year demand but can reset when specifications or lowest-bid frameworks change.
• Clinical positioning: Aimed at rapid administration by non-clinicians; the “autoinjector” value proposition is ease-of-use and reduced user error versus manual delivery.

Where does revenue come from: government contracts, healthcare channels, or consumer?

For naloxone autoinjectors, revenue usually concentrates in institutional and public channel demand rather than pure retail.

Institutional demand funnel (typical)

• Government and quasi-government: State stockpiles, county programs, EMS procurement, law enforcement distribution.
• Healthcare systems: ED discharge programs and inpatient opioid safety initiatives.
• Community programs: School and workplace naloxone programs, often administered via local tenders.

Consumer and caregiver channel (typical)

• Home use depends on reimbursement and patient access programs. It tends to be smaller than institutional sales unless payer coverage improves or co-pay support expands.

How does dosing form competition affect the investment thesis?

Naloxone autoinjectors face substitution risk from:

• Nasal spray naloxone (often cheaper; broadly adopted in community settings)
• Other injector devices with different usability profiles, pricing, and supply terms

Implication for valuation

• Autoinjector differentiation must show operational benefit (training simplification, faster administration, lower misuse) to defend pricing and tender wins.
• If payers default to “lowest total cost per effective reversal,” autoinjectors can be priced down toward nasal spray economics over time.

What are the fundamentals: supply chain, manufacturing complexity, and regulatory path?

Manufacturing and operational constraints that matter to investors

• Device + drug combination: Autoinjectors require validated filling, packaging, and delivery system integration, which raises unit economics stress during ramp-ups or component shortages.
• Stability and lot release: Autoinjector systems can introduce additional stability and assembly verification steps compared with standard syringes or nasal products.
• Service-level risk: Tender-driven purchasing increases exposure to lead-time, inventory placement, and substitution rules if a device component becomes constrained.

Regulatory and labeling drivers

• Device usability claims and administration guidance influence acceptance and reimbursement.
• Autoinjector platform changes (even minor) can trigger regulatory review if they affect delivery characteristics or user interface.

What competitive landscape shapes pricing pressure?

The competitive set includes both branded autoinjectors and alternative naloxone formats.

Competitive vectors that decide market share

• Unit price and tender pricing: Lowest-bid procurement is common, with scoring that can also weight ease-of-use.
• Coverage and reimbursement terms: Pharmacy benefit coverage and contract terms drive retail caregiver volumes.
• Availability reliability: During supply constraints, agencies may favor the supplier with confirmed allocation and delivery cadence.
• Device performance perception: User error rates, needle placement confidence, and training requirements influence procurement decisions even when drug potency is the same.

Investment scenario: Base case, downside case, and upside case

This scenario framework is designed for diligence teams to map revenue sensitivity to institutional tender wins and competitive substitution.

Base case (most likely): slow-to-moderate share erosion to cheaper alternatives

• Institutional customers keep buying autoinjectors but increasingly demand competitive pricing or switch partially to nasal.
• Revenue growth tracks policy momentum (overdose response programs) but is capped by device cost and tender competition.
• Margin compresses gradually as competitive offers pull unit price downward and device manufacturing costs normalize.

What to underwrite

• Continued government and hospital contract retention.
• Supply reliability at tender volumes.
• Clear usability differentiation that prevents full substitution to nasal.

Downside case: aggressive tender-based price resets and faster substitution

• Price resets occur due to competitive bids or specification changes favoring nasal or cheaper injectors.
• Hospitals and public agencies reduce autoinjector mix to manage budgets.
• Device manufacturing inefficiencies or component constraints force higher COGS.

What breaks

• Failure to secure multi-year supply agreements.
• High co-pay exposure with weak payer coverage in home channel.
• Any evidence that user administration concerns reduce procurement preference.

Upside case: policy tailwinds plus device-specific procurement scoring

• Agencies expand naloxone distribution and require autoinjectors for first responder and non-clinician settings.
• Procurement scoring rewards ease-of-use and administration certainty, protecting pricing.
• Broader payer coverage lifts home-care demand.

What lifts

• Evidence of lower administration failure compared with alternatives.
• Contract expansion in EMS and community programs.
• Stable component supply and margin recovery.

Key KPI map for fundamentals monitoring

These indicators separate “policy-driven demand” from “profit-driven durability.”

Market and demand KPIs

• Tender award count and volume for autoinjector units
• Autoinjector mix as a percentage of total naloxone formulations procured
• Institutional reorder rates (signaling contract satisfaction and continued allocation)

Pricing and profitability KPIs

• Net price per unit vs list price (government contracts often define this)
• COGS per unit including device components and fill-finish
• Gross margin trend under supply ramp and competitive re-bids

Execution KPIs

• On-time delivery to contract milestones
• Device availability during component lead-time shocks
• Field performance and adverse event trends tied to usability

What diligence items determine investability for naloxone autoinjectors?

Commercial diligence

• Contract structure: single-year vs multi-year supply
• Pricing mechanics: indexed pricing, rebate structure, and substitution clauses
• Channel mix: government share vs hospital and retail, with payer coverage assumptions

Technical diligence

• Device integration performance, reusability of manufacturing line learnings, and scale-up throughput
• Stability data supporting shelf-life that supports inventory placement by agencies
• Quality system maturity and complaint rates tied to administration defects

Financial diligence

• Unit economics: COGS and device assembly costs at steady state
• Working capital needs from procurement lead times and inventory safety stocks
• R&D spend tied to device improvements and life-cycle extensions

How does policy and reimbursement affect the investment horizon?

Naloxone availability is linked to government overdose-response strategies and healthcare system protocols for opioid safety. Autoinjectors are typically selected when administrations must occur outside clinical settings. Reimbursement evolution can shift demand between institutional and home caregiver use.

Investment interpretation

• If policy continues to expand naloxone distribution and agencies maintain device-based scoring, autoinjectors sustain a pricing floor.
• If policy shifts to cost-minimizing formats, autoinjectors face accelerated substitution and margin risk.

Valuation implications: what drives multiples and downside protection?

Investors should treat the naloxone autoinjector segment as a blend of:

• Public health demand visibility (supports revenue predictability)
• Device-specific competition (creates price and margin compression risk)

Multiples (practical framing)

• Higher valuation is justified when autoinjectors show margin durability through multi-year contracts and limited substitution.
• Lower valuation applies when tenders reset quickly and nasal or other injector alternatives take share.

Downside protection

• Multi-year government supply agreements and strong fulfillment performance.
• Evidence that device usability supports procurement preference beyond “commodity naloxone.”

Key Takeaways

• Naloxone hydrochloride (autoinjector) revenue is primarily driven by institutional procurement, with home-care access a secondary swing factor.
• The central investment risk is substitution and tender-based price compression from nasal naloxone and alternative injector devices.
• Fundamentals come down to contract retention, net pricing mechanics, unit economics, and manufacturing execution at scale.
• Upside exists when procurement scoring rewards autoinjector usability and when policy expands distribution in first responder and non-clinician settings.
• Diligence should prioritize tender structure, pricing reset terms, mix of government vs retail, and evidence of device performance that protects share.

FAQs

1. What determines autoinjector share vs nasal naloxone?
   Procurement scoring, total cost per administered reversal, and ease-of-use evidence that reduces user error for non-clinicians.

2. Why does contract structure matter more than product claims in this category?
   Government tenders often set volumes and net pricing for the investment period, and substitution clauses can re-route demand during re-bids.

3. What are the biggest margin risks for naloxone autoinjectors?
   Device component cost volatility, manufacturing inefficiencies during ramp, and price resets in competitive procurements.

4. What execution KPI best predicts revenue durability?
   On-time delivery and confirmed allocation performance during tender lead times and component supply constraints.

5. Does policy tailwind always translate into autoinjector growth?
   No. Policy expands naloxone access broadly; the format mix depends on reimbursement, procurement scoring, and unit economics versus substitutes.

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References

[1] U.S. Food and Drug Administration. Naloxone drug products information and opioid overdose safety resources. https://www.fda.gov/
[2] World Health Organization. Naloxone in opioid overdose: safety and administration guidance (policy and clinical background). https://www.who.int/
[3] Centers for Disease Control and Prevention. Opioid overdose prevention and naloxone guidance for communities and responders. https://www.cdc.gov/