Details for Patent: 9,814,838

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Which drugs does patent 9,814,838 protect, and when does it expire?

Patent 9,814,838 protects NALOXONE HYDROCHLORIDE (AUTOINJECTOR) and is included in one NDA.

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

Summary for Patent: 9,814,838

Title:	Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Abstract:	Medicament delivery devices for administration of opioid antagonists are described herein. In some embodiments, an apparatus includes a housing, a medicament container disposed within the housing and an energy storage member disposed within the housing. The medicament container is filled with a naloxone composition that includes naloxone or salts thereof, a tonicity-adjusting agent, and a pH-adjusting agent, whereby the osmolality of the naloxone composition ranges from about 250-350 mOsm and the pH ranges from about 3-5. The energy storage member is configured to produce a force to deliver the naloxone composition.
Inventor(s):	Eric S. Edwards, Evan T. Edwards, Mark J. Licata, Paul F. Meyers, Frank E. Blondino
Assignee:	EBAP Inc D/B/A STREAMLINE DESIGN , kaleo Inc
Application Number:	US14/605,512
Patent Claim Types: see list of patent claims	Composition; Compound; Delivery; Device;

Executive summary
US Patent 9,814,838 claims a single-use, prefilled, automatically actuated naloxone delivery apparatus in which a prefilled container holding naloxone at pH ~3 to ~5 is sealed with a specific elastomer formulation (polymer such as bromobutyl or chlorobutyl, cured with sulfur or a metal oxide, optionally silicone based and optionally PDMS coated), and delivery is achieved by moving the container/actuating a needle or delivery member from a fluidically isolated position to a fluid communication position. The central enforceable claim scope is tight around (i) device architecture and two-position fluid isolation, (ii) elastomer compatibility/leach and outgas performance for ≥1–2 years, and (iii) naloxone composition parameters (notably pH 3–5 and tonicity/pH adjusting agents), with several dependent claims narrowing to specific elastomer chemistries, coatings, and droplet-size atomization ranges.

Because the patent is a utility device patent rather than a narrow “chemistry-only” claim, risk for competitors tends to concentrate on device design-arounds that avoid the claimed elastomer formulation/cap sealing requirements and/or the claimed two-position fluidically isolated-to-fluid-communicating needle/delivery member sequencing, and on whether alternative products can credibly change pH/tonicity system and/or sealing material without falling within the “compatible for at least one year” or “minimize leaching/outgassing” language.

What is US Patent 9,814,838 and what does it claim about naloxone delivery devices?

Short answer: US 9,814,838 claims an apparatus combining a prefilled naloxone container, a specific sealing elastomer compatibility regime, and an actuated movement mechanism that transitions a delivery element (needle/delivery member) from fluidically isolated to fluid communication, enabling naloxone delivery.

How broad is the independent claim 1 conceptually?

Claim 1 is framed as an apparatus with these core blocks:

• Housing
• Prefilled medicament container assembly inside housing, comprising:
  • Container
  • Naloxone composition in the container including:
    • Tonicity-adjusting agent
    • pH adjusting agent
    • pH ~3 to ~5
  • Elastomeric member sealing naloxone composition:
    • Must be compatible with naloxone composition for ≥1 year (with dependent claims extending to ≥2 years)
• Needle disposed within the housing
  • Needle end portion is:
    • Fluidically isolated when container assembly is in first position
    • Fluid communication when assembly moves to second position
• Movable member
  • Exerts force on the container assembly to:
    • Move from first to second position
    • Deliver naloxone via needle

Practical claim scope take-away: even if a competitor changes atomization/dose mechanics, claim 1’s enforceable “path” requires all elements together: (a) pH/tonicity-adjusted naloxone, (b) a sealing elastomer compatible for ≥1 year, and (c) a two-position needle isolation/delivery sequence triggered by movement of the prefilled assembly.

What device form factors are implied?

Claim 1 does not mandate a specific brand form, but the mechanics imply a self-actuating, prefilled, needle-based emergency delivery platform.

• The “two-position” needle isolation is a structural and functional limitation.
• The movable member exerts a force that both drives movement and initiates delivery.
• Dependent claims add features consistent with common emergency auto-injectors and actuators: shoulder/engagement portion deformation, energy storage member, retraction spring, and status window.

What patents protect the composition side: naloxone pH 3–5, tonicity agents, antioxidants/chelators?

Short answer: US 9,814,838 ties enforceable device claims to a naloxone formulation range: pH ~3 to ~5 with tonicity adjustment and optional chelators/antioxidants, but the protection is embedded in the apparatus claim not an isolated method-of-making claim.

Which formulation parameters appear in the claims?

Claim 1 and dependent claims repeatedly specify:

• Naloxone composition pH: about 3 to about 5
  • Dependent claim 10 tightens to about 3.2–3.6
• Tonicity-adjusting agent examples:
  dextrose, glycerin, mannitol, potassium chloride, sodium chloride
• pH adjusting agent: included by structure (not further specified in your text, but the claim requires it)
• Optional additives:
  • Chelating agent or antioxidant (claim 11; also in claim 21 and claim 27/“at least one of” in claim 27 language)

How does composition scope interact with elastomer scope?

The elastomer is claimed as compatible with the naloxone composition for ≥1 year (and in some dependents ≥2 years). That language creates enforceability tethered to the formulation context because compatibility is assessed when in contact with naloxone composition.

What does the “compatible for ≥1–2 years” language practically mean for design-arounds?

Competitors typically try to avoid one or more of:

• pH being outside the claimed 3–5 band
• omitting a tonicity-adjusting agent (or using a different tonicity system)
• omitting chelators/antioxidants (where claimed)
• changing the elastomer so it is no longer “compatible” as claimed

If a competitor uses elastomer chemistry that still performs equivalently for a year or two, plaintiffs can argue equivalency under the doctrine of equivalents depending on claim interpretation, but the safest route is usually to avoid the specific elastomer chemistries and/or the claimed performance framing.

What elastomer formulations are claimed, and how do they narrow infringement risk?

Short answer: The strongest narrowing comes from dependent claims that recite elastomer chemistry and coatings: bromobutyl/chlorobutyl with sulfur or metal oxide curing, optional silicone-based material, and optional PDMS coating at 0.02–0.80 mg/cm².

Core sealing requirement in claim 1

• Elastomeric member disposed in container to seal naloxone composition
• Elastomeric member formulated to be compatible with naloxone composition for ≥1 year

Key dependent claim elastomer chemistry and performance

• Claim 5: compatibility for ≥2 years
• Claim 6: elastomer includes:
  • polymer: bromobutyl or chlorobutyl
  • curing agent: sulfur or a metal oxide
• Claim 7: same chemistry plus language to minimize leaching and/or outgassing to achieve ≥2 years compatibility
• Claim 8: at least a portion silicone-based; still includes minimize leaching/outgassing for ≥2 years
• Claim 9: at least portion includes elastomeric member coated with polydimethylsiloxane (PDMS):
  • coating amount ~0.02 mg/cm² to ~0.80 mg/cm²
• Claim 10: combines formulation narrowing (pH 3.2–3.6; tonicity agent list) with elastomer chemistry/performance ≥2 years

How much of the risk is in elastomer chemistry?

• Independent claim 1 does not require bromobutyl/chlorobutyl or curing agent specifics; it requires compatibility for ≥1 year.
• Dependent claims 6/7/10/22/30/31 add explicit chemistry, which is useful for enforcement and also for competitive filtering: if a design uses a different elastomer family (e.g., butyl without the specified cure system, EPDM, halogenated butyl with different cure package, styrenic block copolymer systems, etc.), it may avoid dependent claims but still be exposed to the broader compatibility language in claim 1.

What about “silicone-based” and “PDMS coating”?

Claims 8/9 create a second track:

• Even if a competitor does not use the bromobutyl/chlorobutyl sulfur/metal oxide combination, it could still potentially infringe if its elastomer is both silicone-based and “minimize leaching/outgassing” for ≥2 years (claim 8) and/or meets coating range (claim 9), depending on the overall product structure.

What does the two-position fluid isolation requirement mean: needle fluid communication vs isolation?

Short answer: The apparatus is built around a mechanism where the needle end is fluidically isolated in a first container position and then becomes in fluid communication in a second position after force actuation.

Where is this limitation in the claim set?

• Claim 1: needle end portion fluidically isolated in first position, fluid communication in second position, and container assembly movement causes delivery.
• Claim 15: “delivery member” is fluidically isolated in first position and in fluid communication in second position; delivery is by moving elastomer within the container and moving the prefilled assembly.

How can competitors design around this?

Common non-infringement angles:

• Avoid a true “fluidically isolated first position” structural state for the needle/delivery member during storage.
• Use a different delivery architecture where fluid path is opened via a different event not tied to moving the container assembly to a defined second position.
• Replace needle-based delivery with a delivery member that does not meet the claim’s fluid isolation-to-fluid communication staging language (but claim 15 explicitly covers delivery members generally, including needle by dependent claim 18).

The claim language is relatively strict: “fluidically isolated” and “in fluid communication” are functional descriptors that will likely be mapped to physical seals, check-valves, piercing timing, and port overlap geometry.

What are the movable member and actuator limitations: shoulder deformation, protrusions, springs, and energy storage?

Short answer: Dependent claims narrow the actuation mechanics to shoulders and engagement portion deformation, protrusion engagement limiting reverse movement, and use of an energy storage member and/or retraction spring.

Notable mechanical dependent features

• Claim 2: “single force exerted in one direction” to both move container and deliver
• Claim 4: movable member includes a shoulder configured to deform an engagement portion, then elastomer moves in response after engagement deformation
• Claim 12: optional energy storage member inside housing
• Claim 13: movable member surrounds prefilled assembly; includes protrusion that engages housing to limit reverse movement
• Claim 14: status window shows obstructed vs viewable assembly positions
• Claim 25: force is “a first force” and adds retraction spring within actuator to exert retraction force
• Claims 16/17/24/33/26: similar actuation features mapped to the “actuator” terminology in claim 15 and onward

Why these matter for litigation leverage

• Broad independent claims let you reach more actuators that still accomplish the delivery sequence.
• Dependent claims let the patent owner pursue a closer match on specific mechanical architectures typical of a given marketed device.

Are atomization and droplet size within the patent scope?

Short answer: Yes, claim 20 specifies a droplet size distribution for an atomized spray version.

Claim 19/20 structure

• Claim 19: delivery member configured to atomize naloxone composition
• Claim 20: atomized spray droplet size distribution where:
  • approximately 85% of droplets have size 10 to 150 microns

This is a strong differentiator: many needle-based auto-injectors are not atomizing systems. If a competitor uses a spray platform (e.g., intranasal atomization rather than needle injection), the droplet-size limitation can become an infringement center for that alternative architecture.

What dose and “single dose of about 1 mg” protection exists?

Short answer: Several claims narrow to a single dose naloxone composition of about 1 mg, which aligns with certain intranasal products and some device doses, but it is not in claim 1 proper.

• Claim 3: single dose about 1 mg
• Claim 28: same narrowing for claim 27
• Claim 27 is another independent apparatus claim with similar architecture and elastomer/delivery constraints.

Litigation impact

If an accused product uses a different naloxone dose than ~1 mg, dependent claims 3/28 likely fall away, leaving exposure primarily under the broader claim 1/15/27 architecture and compatibility requirements.

What are the key independent claim set(s) besides claim 1?

Short answer: Your text includes three independent claim groupings: claim 1, claim 15, and claim 27.

Claim 1 (needle + movable member two-position container)

• Needle is the delivery element
• Needle end fluidically isolated vs fluid communication based on container position

Claim 15 (delivery member generic + actuator + elastomer movement)

• Delivery member fluidically isolated vs fluid communication in first vs second position
• Actuator causes force:
  • move prefilled container from first to second position
  • move elastomer within container to deliver via delivery member

Claim 27 (movable member matingly engages assembly + shoulder deformation)

• Includes movable member that matingly engages the prefilled medicament container assembly
• Shoulder deforming engagement portion, then elastomer moves
• Broadly retains:
  • naloxone pH 3–5
  • tonicity and elastomer compatibility ≥1 year
  • delivery member fluid isolation first position vs fluid communication second position

From an enforcement standpoint, multiple independent claim forms increase product coverage for variations in actuator terminology and engagement geometry.

Detailed patent landscape: what can be inferred from the claim set, and where the likely crowded prior art sits?

Short answer: With only the claims text for US 9,814,838, the most defensible landscape characterization is by technical feature clusters that are typically crowded in naloxone emergency device IP: (i) auto-actuated prefilled injector architecture, (ii) two-position fluid path isolation, (iii) elastomer compatibility and container sealing for shelf-life, and (iv) formulation pH/tonicity stabilization strategies.

Crowding cluster A: auto-injector/injection delivery sequencing

Feature elements:

• prefilled container inside housing
• actuated movement to activate needle/delivery
• isolation during storage and connection during use

This cluster tends to be heavily patented across brands (including auto-injectors and needle-shield safety architectures). The 9,814,838 differentiator is the tight linkage to the elastomer compatibility regime and the naloxone composition pH/tonicity band.

Crowding cluster B: elastomer container sealing for chemical stability and leach/outgas control

Feature elements:

• elastomer formulated to be compatible for ≥1–2 years
• minimizing leaching and outgassing
• specific chemistries (bromobutyl/chlorobutyl with sulfur/metal oxide cure)
• silicone-based portion and PDMS coatings at specified mg/cm²

This cluster is usually less about the delivery mechanics and more about materials science and extractables/leachables. Competitors often select different elastomer families or coatings to avoid both explicit chemistry and performance characterization.

Crowding cluster C: naloxone formulation stabilization at acidic pH with tonicity balancing

Feature elements:

• pH 3–5 and pH 3.2–3.6 dependent
• tonicity agents list
• optional chelators/antioxidants

Naloxone formulation patents exist broadly for stability, but this patent uses formulation parameters inside a device claim. That can still create meaningful leverage if a competitor uses the same pH/tonicity system and still infringes on the delivery architecture and elastomer compatibility.

What is the likely enforceability posture of US 9,814,838 based on claim structure?

Short answer: The claims are composition-and-materials tethered to a device architecture, which strengthens non-trivial aspects of novelty but also increases invalidity risk if prior art shows the same combination of:

• acidic naloxone with tonicity adjustment
• standard auto-injector sequencing for needle isolation to fluid communication
• known elastomer compatibility measures at one to two years and/or known specific elastomer cure systems

Without the full file history and cited references, the only strict statement is structural: the independent claims are broad around the apparatus but narrowed in multiple dependents to specific elastomer chemistries, coating amounts, and droplet size.

What generic entry risks exist for products that compete with the claimed naloxone device?

Short answer: “Generic entry” for device-based naloxone is typically not “generic drug substitution” but rather device equivalent redesign or a new device platform that avoids claim features. Risk concentrates on whether an alternative device:

1. uses a single-dose ~1 mg (for dependent coverage),
2. uses naloxone pH in 3–5 (or 3.2–3.6),
3. uses a sealing elastomer that is both compatible for ≥1–2 years and matches bromobutyl/chlorobutyl with the listed curing agents or the silicone/PDMS coating parameters, and
4. uses a needle or delivery member with the claimed two-position fluid isolation/communication sequence.

A redesign that changes only the needle geometry may still infringe if the container sealing and fluid isolation staging remain within the claim definitions.

Key Takeaways

• US 9,814,838 is an apparatus patent for an actuated prefilled naloxone delivery system with two-position fluid isolation of a needle/delivery member.
• The patent’s most distinctive constraints are:
  • Naloxone pH 3–5 (and dependent 3.2–3.6) with tonicity adjustment and optional chelators/antioxidants.
  • A sealing elastomeric member required to be compatible for ≥1 year (and in multiple dependents ≥2 years) with explicit elastomer chemistries and coatings (notably bromobutyl/chlorobutyl, sulfur or metal oxide curing, optional silicone-based materials, and PDMS coating 0.02–0.80 mg/cm²).
• Dependent claims create enforcement granularity around specific device mechanics (shoulder/engagement deformation, protrusion limits, springs/energy storage, status windows) and alternative delivery (atomized sprays with specified droplet size distribution).
• Competitor exposure is driven by whether the accused product preserves the claim’s fluid path staging plus the elastomer compatibility/material constraints tied to the naloxone formulation.

FAQs

1) Does US 9,814,838 cover intranasal atomization devices?
It can cover atomization variants if the delivery member is configured to atomize and meets the claimed droplet size distribution limitation in claim 20, and the rest of the apparatus and elastomer/formation constraints are met.

2) If a device uses a different naloxone pH (outside 3–5), does it avoid infringement?
Because the claims require naloxone composition pH ranges (claim 1/15/27), moving outside the claimed pH band is a primary design-around pathway, subject to how courts construe and measure pH and whether other claim elements still match.

3) Is the elastomer chemistry required in the broadest claim?
Claim 1 requires elastomer “compatibility” for ≥1 year but does not, in the independent claim text you provided, require bromobutyl/chlorobutyl or the specific cure agents. Dependent claims do.

4) Can changing the needle shape alone design around the “fluidically isolated” requirement?
Not reliably. The two-position “fluidically isolated” to “fluid communication” limitation is about the functional fluid path state during first vs second positions, which is typically governed by sealing and port alignment more than needle exterior geometry.

5) Does the “about 1 mg” dose limitation apply to all claims?
No. The ~1 mg single-dose limitation appears in dependent claims (e.g., claim 3 and claim 28). Independent claim scope in your text is not limited to that dose.

References

No sources were cited because no patent bibliographic data (publication number, assignee, prosecution history, cited prior art, or Orange Book/FDA listings) was provided in the prompt beyond claim text.

Drugs Protected by US Patent 9,814,838

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	9,814,838		Y

International Family Members for US Patent 9,814,838

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011218756
Australia	2012211307
Australia	2012211320
Australia	2015255197
Brazil	112013018807