Details for Patent: 9,474,869

Which drugs does patent 9,474,869 protect, and when does it expire?

Patent 9,474,869 protects EVZIO, EVZIO (AUTOINJECTOR), and NALOXONE HYDROCHLORIDE (AUTOINJECTOR), and is included in three NDAs.

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

Summary for Patent: 9,474,869

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, Frank E. Blondino
Assignee:	kaleo Inc
Application Number:	US14/694,725
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Device;

United States Patent 9,474,869: Naloxone Delivery Device Scope, Patent Landscape, and Generic Entry Risk

US Patent No. 9,474,869 protects a single-dose naloxone delivery system that combines a prefilled medicament container, a pH-controlled naloxone formulation, a silicone-based elastomeric member, and an actuator-driven coupling mechanism. The patent reaches both intranasal atomizer products and needle-based delivery configurations.

The strongest commercial coverage is directed to a preassembled, shelf-stable naloxone device in which actuation first punctures or opens the container and then displaces the elastomeric member to deliver the dose. A competing product may avoid infringement by changing the container-opening mechanism, separating the atomizer from the container, using a non-silicone elastomeric contact surface, or omitting the claimed formulation limitations.

The patent does not broadly cover every naloxone nasal spray. Infringement generally requires the claimed combination of structural, formulation, and actuation elements.

What patent protects naloxone delivery device US 9,474,869?

US 9,474,869 is directed to integrated naloxone delivery devices and methods of using them. The patent has four independent claims:

Claim	Category	Principal scope
1	Apparatus	Housing, naloxone container, silicone-based elastomer, pH 3-5 formulation, coupling transition, actuator, single-dose delivery
14	Method	Removing the device from a case, positioning it at a patient target, and actuating the device to open the fluid path and deliver naloxone
27	Method	Intranasal delivery using an atomizer, a single-dose naloxone composition, and actuator-driven container movement
37	Apparatus	Intranasal atomizer device with the same container, formulation, elastomer, coupling, and actuator architecture

The claims are written as combination claims. The patent does not claim naloxone composition, a syringe, or an atomizer in isolation.

What are the essential elements of claim 1?

Claim 1 requires all of the following:

1. A housing.
2. A medicament container assembly at least partly within the housing.
3. A container body containing a naloxone composition.
4. A tonicity-adjusting agent.
5. A pH-adjusting agent.
6. A naloxone composition with a pH from 3 to 5.
7. An elastomeric member inside the container body.
8. The elastomeric member including a silicone-based material.
9. A delivery member coupled to a coupling member.
10. A first configuration in which the delivery member is fluidically isolated from the container.
11. A second configuration in which the delivery member communicates with the container.
12. An actuator that causes both the configuration change and delivery of a single dose.

The claim therefore has three main technical pillars:

• the naloxone formulation;
• the container and elastomer arrangement; and
• the staged opening-and-delivery mechanism.

A device that satisfies only one or two of those pillars should not literally infringe claim 1.

How broad are the apparatus claims?

Claims 1 and 37 are broadest in device architecture, but they differ materially.

Claim 1 covers needle and atomizer configurations

Claim 1 defines the delivery member generically. Dependent claims confirm that the delivery member may be:

• a needle;
• an atomizer;
• a needle connected to a downstream intranasal flow path; or
• a delivery structure that dispenses through an opening in the housing.

Because claim 1 does not expressly require intranasal delivery, it can potentially reach certain injectable or other delivery configurations if the remaining limitations are present.

Claims 3, 4, 8, 12 and 13 narrow the needle-based embodiments. They address:

• needle placement outside the container before actuation;
• needle entry into the container after actuation;
• 19-to-31 gauge needles;
• an intranasal outlet downstream from the needle; and
• a container shoulder or housing opening.

Claims 5 and 6 address atomizers. Claim 6 requires a spray in which 85% of droplets are between 10 and 150 microns.

Claim 37 is expressly intranasal

Claim 37 requires:

• an atomizer;
• a single dose of naloxone;
• a pH-adjusted formulation with pH from 3 to 5;
• a silicone-based elastomeric member;
• a fluid-isolation-to-fluid-communication transition; and
• an actuator that both opens the fluid path and delivers the dose.

Claim 37 is narrower than claim 1 because the atomizer is mandatory. It may nevertheless be commercially important because it maps more directly onto a preassembled naloxone nasal spray.

What formulation limitations are protected?

The patent does not claim every naloxone formulation. The independent claims require a pH-adjusting agent and a pH range of 3 to 5. Claim 37 also requires the composition to contain a tonicity-adjusting agent.

The dependent claims add the following formulation limitations:

Claim	Formulation limitation
9	Sodium chloride concentration from 0.1 mg/mL to 20 mg/mL
10	Naloxone composition concentration from 0.01 mg/mL to 60 mg/mL
21	Tonicity agent includes dextrose, glycerin, mannitol, potassium chloride or sodium chloride
25	Sodium chloride concentration from 0.1 mg/mL to 20 mg/mL
26	Naloxone composition concentration from 0.01 mg/mL to 60 mg/mL
32	Tonicity agent includes dextrose, glycerin, mannitol, potassium chloride or sodium chloride
41	Sodium chloride concentration from 0.1 mg/mL to 20 mg/mL
42	Naloxone composition concentration from 0.01 mg/mL to 60 mg/mL

The ranges are broad. A conventional aqueous naloxone nasal spray may fall within them, particularly if it uses sodium chloride for tonicity and has an acidic pH. Formulation analysis must use the actual finished-product specification, not only the label strength.

The claim language creates a potential design-around route if a product uses:

• a formulation outside the pH range;
• a different tonicity strategy;
• no pH-adjusting agent;
• a nonaqueous or substantially different vehicle; or
• concentrations outside the dependent-claim ranges.

Avoiding a dependent claim does not avoid claim 1 or claim 37 if the independent claim is otherwise met.

What container and elastomer features are covered?

The patent requires an elastomeric member disposed within the internal volume of the container body and including a silicone-based material. Claim 11 expressly covers an elastomeric member with at least part of its surface coated with silicone-based material.

This limitation is significant for prefilled syringe technology. It may cover:

• a silicone-based stopper;
• a silicone-coated plunger;
• a silicone-containing piston; or
• another internal elastomer used to displace the naloxone formulation.

The claim language does not necessarily require the entire elastomeric member to be made from silicone. “Including a silicone-based material” can encompass a composite or coated structure, subject to claim construction and the patent’s specification.

A product using a non-silicone elastomer may reduce risk under the literal claim language. A product using a fluoropolymer, bromobutyl, chlorobutyl, or other elastomer with no silicone component would present a stronger noninfringement position, although the doctrine of equivalents could remain relevant depending on the product design and prosecution history.

How does the coupling and actuator mechanism operate?

The patent claims a two-stage operational sequence:

1. The device begins in a first configuration in which the delivery member is isolated from the container.
2. Actuation transitions the container and coupling member into a second configuration.
3. The delivery member enters or communicates with the container.
4. Continued force moves the elastomeric member.
5. The single dose exits through the needle, atomizer, or outlet.

Claims 2, 7, 15, 16, 18, 19, 24, 29, 35, 38 and 40 emphasize relative movement between the container assembly and coupling member.

This sequence distinguishes the claimed device from a conventional nasal spray pump in which the formulation is already connected to the pump and the user merely depresses a plunger. The patent is most relevant to systems that keep the formulation isolated until activation, then create the fluid path and deliver the dose in a single user action.

What actuation modes are covered?

The dependent claims cover:

• manual depression;
• manual pressing;
• manual squeezing;
• movement of an actuator from a first to a second position; and
• application of force divided between container movement and elastomer movement.

The claims are not limited to a particular spring, lever, button, trigger, or housing geometry. A different external actuator may still infringe if it performs the claimed functions through the claimed structural arrangement.

What intranasal delivery features are protected?

The intranasal claims cover an atomizer connected to the container through the coupling member. The atomizer defines an orifice through which naloxone is delivered to a nostril.

Relevant limitations include:

• the distal end of the housing positioned at or near a nostril;
• an atomizer coupled to the medicament container assembly;
• a needle or piercing member forming part of the internal flow path;
• a downstream atomizer orifice; and
• a droplet distribution in which 85% of droplets measure 10 to 150 microns.

The droplet limitation is a technical performance limitation. In a patent dispute, infringement may depend on laser diffraction, cascade impaction, or another validated spray-characterization method. A generic label statement that the product is “intranasal” would not establish whether the 85% droplet limitation is met.

How many claims are potentially relevant to a commercial naloxone nasal spray?

For a prefilled, single-dose naloxone nasal spray, the principal claims are:

• claim 1;
• claims 5, 6, 7, 8, 9, 10 and 11;
• claims 14, 17, 18, 19, 20, 21, 22, 23 and 24;
• claims 25 and 26;
• claims 27 through 36; and
• claims 37 through 42.

Claims 27 and 37 are the most product-specific because they expressly require an atomizer, a single dose, intranasal placement, and actuator-driven delivery.

Claims 14 and 27 are method claims. They may create infringement issues for commercial use, instructions for use, testing, distribution, or inducement depending on the accused conduct and the specific method steps.

When does US 9,474,869 lose exclusivity?

The patent’s expiration date must be determined from the earliest effective nonprovisional priority date, any terminal disclaimer, and patent-term adjustment. A standard 20-year term is measured from the earliest effective US nonprovisional filing date under 35 U.S.C. § 154.

Based on the patent’s 2016 issue date, the patent is likely to have a nominal expiration in the early 2030s, subject to patent-term adjustment and any terminal disclaimer. The issue date alone does not establish the expiration date. The authoritative date is the term information in USPTO Patent Center and the patent’s face data.[1]

The patent may also be subject to regulatory exclusivity that expires separately from patent rights. FDA exclusivity and patent expiration are independent. A product can lose FDA exclusivity before all patents expire, or patent protection can expire while regulatory barriers remain.

What is the FDA Orange Book status of US 9,474,869?

The Orange Book controls listed patents for approved drug products, not the general validity or enforceability of every patent that may relate to a product. The relevant FDA analysis should identify:

• the approved naloxone product;
• the NDA holder;
• patent listings for the drug substance, formulation, method of use, and device;
• patent-use codes;
• delisting or expiration events; and
• whether an ANDA applicant made a Paragraph IV certification.

For a naloxone nasal spray, the Orange Book listing may not include every patent in the broader patent family. Device claims are listed only when the NDA holder identifies them as satisfying the applicable listing requirements. The presence or absence of US 9,474,869 in the Orange Book does not determine whether a generic product could face a patent infringement action under 35 U.S.C. § 271(e)(2).

What Paragraph IV challenges affect this patent?

An ANDA applicant seeking approval for a generic naloxone nasal spray may certify under Paragraph IV that a listed patent is invalid, unenforceable, or will not be infringed. If the patent is listed for the reference product, a Paragraph IV notice can trigger Hatch-Waxman litigation and a potential 30-month approval stay under 21 U.S.C. § 355(j)(5)(B)(iii).

A Paragraph IV challenge to this patent would likely focus on:

• whether the accused generic has the claimed coupling sequence;
• whether the generic has a silicone-based internal elastomer;
• whether the naloxone formulation contains the claimed pH-adjusting and tonicity-adjusting agents;
• whether the pH is within 3 to 5;
• whether the product delivers a single dose;
• whether the atomizer satisfies the droplet-size limitation; and
• whether the asserted claims are anticipated or obvious over prefilled syringe and nasal atomizer references.

The patent is vulnerable to combination-based obviousness arguments because its claims combine known device elements, including containers, elastomeric plungers, piercing needles, actuators, and nasal atomizers. The patentee’s strongest response would be evidence that the claimed arrangement solved shelf-life, container integrity, activation reliability, dose delivery, or formulation compatibility problems not predictably solved by the cited references.

No conclusion on a particular Paragraph IV case should be drawn without matching the notice letter, asserted claims, ANDA product, and court docket.

What patent litigation affects US 9,474,869?

Patent litigation analysis should separate three categories:

Category	Relevance
Orange Book litigation	ANDA applicant challenges to listed patents
Device patent litigation	Disputes over the integrated container, actuator, coupling, or atomizer
Product liability or regulatory litigation	Matters that may not determine patent validity or infringement

The relevant litigation record should be checked through PACER, the Federal Circuit, USPTO Patent Center, FDA’s Orange Book, and FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations.[1-4]

A litigation docket involving Narcan, naloxone nasal spray, or an affiliated company does not automatically involve US 9,474,869. Patent-family members often have different claims, expiration dates, terminal disclaimers, and prosecution histories.

Which companies are challenging the naloxone nasal spray patent estate?

The principal competitive groups in naloxone nasal delivery include:

• the reference-product sponsor and its successor or licensing partners;
• generic pharmaceutical companies pursuing abbreviated approval;
• contract manufacturers supplying nasal atomizers or prefilled containers;
• companies commercializing over-the-counter naloxone;
• nonprofit or public-sector developers of low-cost naloxone products.

Commercial competitors may avoid the patent by using a conventional pump bottle, a separate container-and-atomizer assembly, a different elastomer, or a formulation outside the claimed ranges. Generic competition can therefore arise even if the patent remains in force, provided the ANDA product does not infringe valid asserted claims or the applicant prevails in litigation.

How strong is the patent estate for US 9,474,869?

The patent’s strength is mixed.

Strengths

• It claims a complete commercial device rather than an isolated component.
• It covers both apparatus and method categories.
• It captures a staged fluid-path activation sequence.
• It includes formulation and container-material limitations.
• It has dependent claims directed to common naloxone nasal spray parameters.
• It can reach products using an atomizer downstream of a piercing needle.

Weaknesses

• The claims combine multiple known technologies, creating obviousness exposure.
• The pH range of 3 to 5 is broad.
• The tonicity-agent limitations may read on conventional pharmaceutical formulations.
• “Silicone-based material” may be vulnerable to written-description, claim-construction, or design-around disputes.
• Some claims contain functional language that may require detailed construction.
• The droplet-size limitation may be difficult to establish consistently across lots and test methods.
• Claims 1 and 14 are broad enough to invite prior-art attacks, but their combination requirements may complicate infringement proof.

The most defensible commercial position may reside in claims 27 and 37 when the accused product clearly uses a single-dose, preassembled intranasal device with staged needle entry and an internal silicone-based elastomer.

What generic launch scenarios exist?

Scenario 1: No listed patent barrier

A generic applicant can obtain approval after satisfying the FDA’s safety, efficacy, quality, and bioequivalence requirements, subject to any remaining exclusivity. The applicant may launch if the product does not infringe unlisted patents or if the sponsor does not pursue litigation.

Scenario 2: Paragraph IV litigation

If the patent is listed and the applicant submits a Paragraph IV certification, litigation may produce a 30-month stay. The generic may prevail through invalidity or noninfringement, or the parties may settle.

Scenario 3: Carve-out or skinny label

A method-of-use carve-out may reduce exposure to a use patent. It is less useful against apparatus or formulation claims that cover the product itself.

Scenario 4: Design-around launch

A generic may use:

• a conventional nasal pump;
• a container that is already fluidically connected;
• a non-silicone elastomer;
• a different pH or tonicity system;
• a multidose rather than single-dose format; or
• an atomizer with a different delivery architecture.

A design-around must be evaluated against every asserted claim, including equivalents and induced-infringement theories.

What licensing and commercial relationships matter?

The commercial value of US 9,474,869 depends on ownership and licensing across the patent family. Relevant diligence points include:

• assignment history in USPTO Patent Center;
• exclusive or nonexclusive licenses;
• rights retained by inventors or research institutions;
• sublicenses to the NDA holder;
• change-of-control provisions;
• royalty obligations;
• field-of-use restrictions; and
• obligations triggered by generic entry or over-the-counter commercialization.

A patent assignment does not establish a product license. Conversely, a product sponsor may have rights under a confidential license not visible in the public patent assignment record.

What geographic coverage does the patent provide?

US 9,474,869 provides protection only in the United States. Foreign counterparts must be reviewed separately. Relevant family jurisdictions may include:

• PCT filings;
• European Patent Office applications;
• Canadian applications;
• Australian applications;
• Japanese applications; and
• other national-phase filings.

Foreign claims may differ substantially. A US claim covering a silicone-based elastomer and pH 3-to-5 formulation does not establish equivalent protection in Europe or Canada. National prosecution, opposition, terminal disclaimers, maintenance fees, and claim amendments must be checked independently.

What manufacturing and intellectual-property barriers remain?

The patent is most relevant to manufacturers producing a fully integrated naloxone device. Manufacturing barriers include:

• validated silicone-coated or silicone-containing elastomer components;
• container closure integrity;
• long-term compatibility between naloxone and elastomer surfaces;
• reliable needle penetration after storage;
• consistent single-dose displacement;
• atomizer performance;
• droplet-size control;
• assembly under sterile or controlled conditions; and
• stability through the claimed six-month and one-year storage periods.

Claims 22 and 23 add storage-related limitations. They require storage in a case for at least six months or maintenance of the naloxone composition in the container for at least one year. Those limitations may require stability evidence and can create factual disputes in litigation.

Key Takeaways

• US 9,474,869 claims an integrated naloxone delivery system, not naloxone alone.
• The core combination is a pH 3-to-5 naloxone composition, tonicity agent, silicone-based elastomer, staged fluid-path opening, and actuator-driven single-dose delivery.
• Claims 27 and 37 are the most directly relevant to single-dose intranasal naloxone products.
• The patent reaches both atomizer and needle-based embodiments through different claim branches.
• A conventional nasal spray may avoid infringement if it lacks the claimed staged coupling transition or silicone-based internal elastomer.
• Formulation, droplet size, container materials, and activation sequence are central infringement issues.
• Expiration must be confirmed from USPTO patent-term data rather than inferred from the issue date.
• FDA Orange Book listing, Paragraph IV certification, and patent infringement are related but separate inquiries.
• Generic launch risk depends on the actual device architecture, formulation specification, patent listing status, and any settlement or litigation outcome.

FAQs

Does US 9,474,869 cover Narcan nasal spray?

It may cover products with the claimed combination of a single-dose naloxone formulation, pH from 3 to 5, silicone-based internal elastomer, staged container opening, and atomizer delivery. The product name alone does not establish infringement.

Can a generic naloxone nasal spray avoid this patent by changing the pH?

Changing the pH outside the claimed 3-to-5 range may avoid a literal pH limitation, but the generic must still evaluate the remaining apparatus and method claims and potential equivalents.

Does a silicone-coated plunger fall within the patent?

It may. Claim 11 expressly addresses an elastomeric member with at least part coated with silicone-based material. The precise result depends on the construction of the claim and the product’s elastomer structure.

Are all naloxone atomizers covered by the patent?

No. The patent requires additional elements, including the container assembly, formulation characteristics, elastomer, coupling transition, and actuator. An atomizer alone is outside the principal combination claims.

Can an over-the-counter naloxone product infringe US 9,474,869?

Yes. FDA prescription or over-the-counter status does not determine patent infringement. An OTC product using the claimed device and formulation architecture could face the same patent analysis.

References

1. United States Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/
2. United States Patent and Trademark Office. (n.d.). Manual of Patent Examining Procedure, 2710: Patent term. https://www.uspto.gov/web/offices/pac/mpep/mpep-2700.html
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
4. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
5. United States Congress. (2012). Leahy-Smith America Invents Act, 35 U.S.C. § 154. https://www.govinfo.gov/content/pkg/USCODE-2023-title35/html/USCODE-2023-title35-partII-chap14-sec154.htm
6. United States Congress. (1984). Drug Price Competition and Patent Term Restoration Act, 21 U.S.C. § 355. https://www.govinfo.gov/content/pkg/USCODE-2023-title21/html/USCODE-2023-title21-chap9-subchapV-partA-sec355.htm

Drugs Protected by US Patent 9,474,869

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	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014		DISCN	Yes	No	9,474,869		Y			USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	9,474,869		Y			USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	9,474,869		Y			USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE

International Family Members for US Patent 9,474,869

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