US Patent 10,076,614: Scope, Claims, Expiration and Nasal Delivery Device Patent Landscape

US Patent 10,076,614 protects a mechanically defined exhalation-powered nasal delivery device. Its core invention is the flexible coupling between the mouthpiece and housing. The claims require asymmetric translation of the mouthpiece, with greater permitted movement along the nosepiece axis than in the orthogonal direction facing the user. The patent does not claim a particular active pharmaceutical ingredient, formulation, indication, or dosing regimen.

The patent is most relevant to exhalation delivery systems in which a user exhales through a mouthpiece while a substance is delivered through a sealed nasal interface. The commercial risk is concentrated in device implementation, particularly the geometry, resilience, movement ratios, angular range, and material properties of the coupling.

What does US Patent 10,076,614 protect?

The independent claims protect two substantially overlapping device configurations:

Claim group	Independent claim	Protected subject matter
First claim set	1	Nasal delivery device with housing, nosepiece, exhalation mouthpiece and flexible coupling
Second claim set	32	Parallel nasal delivery device claim using substantially the same core limitations
Supply-unit limitation	31 and 47	Device further including a manually actuated substance supply unit

The central limitation is not simply a flexible mouthpiece. The coupling must constrain movement so that:

The mouthpiece translates asymmetrically relative to the nosepiece.
Movement in a first direction along the longitudinal axis of the nosepiece is greater than movement in a second orthogonal direction facing the subject.
The mouthpiece begins from an initial untranslated position.

A competing device with a flexible connection that permits unrestricted multidirectional movement may fall outside the literal scope if it does not produce the claimed directional movement relationship. A device with a rigid mouthpiece or a coupling that allows equivalent movement in both directions also presents a stronger noninfringement position.

How are the claims structured?

Independent claims 1 and 32

Claims 1 and 32 are apparatus claims. Each requires:

A housing.
A nosepiece for fitting to the nasal cavity.
A mouthpiece through which the user exhales.
An initial untranslated position for the mouthpiece.
A flexible coupling between the mouthpiece and housing.
Asymmetric translation relative to the nosepiece.
Greater permitted movement along the nosepiece axis than in the orthogonal, user-facing direction.

The claims are functional and structural. A court would likely examine both the physical coupling architecture and whether the device permits the claimed directional movement.

The duplication between claims 1 and 32 creates two independent infringement routes, although the claims are materially similar. Claim 32 omits the claim-10 dependent architecture from the dependency chain and presents a shorter independent formulation.

Nosepiece and sealing limitations

Claims 2, 3 and 33 add:

An outlet for substance delivery.
A seat against which the nostril nare rests.
A sealing fit with the nasal cavity.
A tapered section positioned within the nasal cavity and widening toward the housing.

These limitations narrow the claims toward a sealed nasal interface rather than a conventional open nasal spray nozzle. The sealing seat and tapered section are important design-around points. A nasal device that does not seat against the nare, or that uses a substantially different sealing mechanism, may avoid these dependent claims while remaining exposed to claims 1 or 32.

Mouthpiece limitations

Claims 4 and 5 require a tubular mouthpiece section, made from rigid or semi-rigid material. These claims distinguish the exhalation conduit from a fully flexible mouthpiece.

The independent claims do not expressly require a tubular mouthpiece. A device may therefore remain within claims 1 or 32 even if its mouthpiece geometry differs, provided the coupling and asymmetric movement limitations are satisfied.

What flexible coupling structures are protected?

Claims 6 and 34 broadly identify the flexible coupling as a resilient element. Claims 10 through 19 provide the main structural detail.

Claim	Limitation
6, 34	Flexible coupling is a resilient element
10	Annular coupling member attached to housing and mouthpiece; exhalation delivers airflow into housing
11	Hinge section permits movement toward or away from nosepiece
12	Hinge section is on the nosepiece-proximate side
13	Coupling member has a shorter dimension on that side
14	Dimension progressively increases toward the distal side
15	Arcuate or bowed profile
16	Profile stretches in one direction and compresses in the other
17	Outward bow creates unequal biasing forces
18, 19	Graded material with lower resilience near the nosepiece
28-30	Thermoplastic elastomer with a durometer of about 40-60, or 45-55

The broadest practical device limitation is the resilient coupling combined with directional movement. The annular member, bowed profile, hinge position, graded resilience and TPE durometer are progressively narrower embodiments.

A product using a molded elastomeric bellows, compliant hinge, flexure, overmolded connector or anisotropic elastomer could present infringement risk if its operation satisfies the directional movement limitation. The patent does not appear limited to one particular manufacturing process.

How strong are the movement-ratio claims?

Claims 7-9 and 35-37 quantify the movement differential:

Claims	Required movement ratio
7, 35	At least 1.5:1
8, 36	At least 1.75:1
9, 37	At least 2:1

These claims create measurable infringement tests. Product clearance should measure displacement in both claimed directions from the initial untranslated position. The relevant question is permitted movement, not necessarily the distance traveled during ordinary use.

The ratio limitations may strengthen validity by adding objective parameters, but they can complicate enforcement. The patent owner would need reliable test methodology defining:

The reference point on the mouthpiece.
The longitudinal axis of the nosepiece.
The orthogonal direction facing the user.
The maximum permitted movement.
Whether movement is measured under a specified force or under normal exhalation conditions.

A competitor may challenge infringement by disputing the measurement protocol or by designing movement below the claimed ratios. Claims 1 and 32 remain broader because they do not specify a numerical threshold beyond requiring greater movement in the first direction.

What angular geometry is protected?

Claims 20-27 and 38-46 cover the starting angle and movement angles of the mouthpiece.

Feature	Broad range	Narrower ranges
Initial mouthpiece angle	About 45°-55°	About 48°-52°
Movement toward nosepiece	About 7°-17°	About 9°-15°; about 10°-14°; about 12°
Movement away from nosepiece	About 4°-10°	About 5°-9°; about 6°-8°

These claims are directed to ergonomic positioning and controlled mouthpiece deflection. The most commercially specific embodiment is a starting angle of approximately 50°, movement toward the nosepiece of approximately 12°, and movement away from the nosepiece of approximately 7°.

A device with a different mouthpiece angle may avoid these angular claims while remaining within claims 1 or 32. The angular claims are therefore important for product configurations closely matching the disclosed commercial design, but they do not define the full patent scope.

What formulations and substances are protected?

US Patent 10,076,614 does not claim a specific formulation or active ingredient. Claim 31 and claim 47 refer to a manually actuated substance supply unit, but the claims do not specify:

Fluticasone propionate.
Any other corticosteroid.
A powder, suspension, solution or aerosol.
Particle size.
Dose strength.
Preservatives or excipients.
A therapeutic indication.
A particular pump or metering mechanism.

The patent may therefore cover a device used with multiple substances if the device meets the structural and functional limitations. It does not independently provide composition-of-matter protection for a drug.

What is the Orange Book status of US Patent 10,076,614?

US Patent 10,076,614 is a device patent rather than an active-ingredient or formulation patent. Its Orange Book relevance depends on whether it is submitted and accepted as a patent for an approved drug-device combination product.

For a product such as an exhalation delivery system combined with a nasal drug, the FDA may consider device patents in the context of the approved product and patent certification framework. A patent number appearing in an NDA’s Orange Book listing would be product-specific and should not be inferred solely from the patent’s subject matter. The FDA Orange Book is the controlling source for current listing status and patent-use-code information.[1]

The patent claims do not themselves establish an Orange Book listing, a regulatory exclusivity period, or an automatic Paragraph IV pathway.

When does US Patent 10,076,614 lose exclusivity?

The patent was granted on July 17, 2018. Its nominal term is generally calculated from the earliest effective nonprovisional filing date in the priority chain, subject to patent-term adjustment, patent-term extension and any terminal disclaimer.[2]

Based on the disclosed priority structure associated with this patent family, the unadjusted term is expected to run into 2034. The legally operative expiration date requires the USPTO Patent Center record and the patent’s term-adjustment calculation. A patent’s grant date is not its expiration date.

Event	Date or status
US patent grant	July 17, 2018
Patent type	Utility patent
Core technology	Exhalation-powered nasal delivery device
Nominal term	Generally 20 years from the applicable earliest nonprovisional filing date
Expected unadjusted expiry window	2034
PTA/PTE effect	Must be checked in USPTO and FDA records
Post-expiry risk	Device claims cease to block ordinary practice after expiration, subject to other family patents

A product clearance review must assess the entire patent family. Expiration of US 10,076,614 would not eliminate risk from continuation patents, separately issued formulation patents, method-of-use patents or other device patents.

Are there Paragraph IV challenges to this patent?

A Paragraph IV certification is relevant only if the patent is listed in the Orange Book for a specific approved drug product and an ANDA applicant challenges that listing.[3] The patent number alone does not establish that an ANDA applicant has filed a Paragraph IV certification.

For a device-focused patent, the likely litigation posture differs from a conventional small-molecule product patent. Potential challengers may include:

ANDA applicants seeking approval of a therapeutically equivalent nasal product.
505(b)(2) applicants using a different delivery device.
Device manufacturers developing a competing exhalation system.
Drug sponsors seeking to separate the active ingredient from the patented delivery architecture.

The principal legal issues would likely include claim construction, anticipation, obviousness, literal infringement, doctrine of equivalents, enablement and written description. The numerical movement ratios and angular ranges may be vulnerable to prior-art and obviousness attacks if earlier nasal delivery devices disclosed flexible mouthpiece couplings, directional hinges or comparable ergonomic geometry.

What prior-art and design-around issues matter most?

The patent’s strongest commercial reach is concentrated in claim 1 and claim 32. The most important technical limitations are:

Flexible coupling.
Relative translation rather than only rotation.
Asymmetric movement.
Greater movement along the nosepiece axis.
A mouthpiece used for exhalation.
A nosepiece fitted to the nasal cavity.

Potential design-around strategies include:

Using a rigid mouthpiece with a flexible nosepiece.
Using a coupling that rotates without translating.
Allowing symmetric movement in the relevant directions.
Moving the entire housing rather than the mouthpiece.
Using a separate exhalation conduit not coupled through the claimed flexible element.
Avoiding the annular coupling architecture.
Using an alternative nasal seal.
Designing measured movement below the 1.5:1, 1.75:1 or 2:1 dependent-claim thresholds.
Changing the starting angle or deflection angles.

These strategies do not automatically avoid claims 1 or 32. They must be assessed against the complete claim language and the doctrine of equivalents.

How does this patent compare with formulation and method-of-use patents?

Patent category	What it protects	Relevance to US 10,076,614
Device patent	Housing, nosepiece, mouthpiece, coupling and mechanics	Directly relevant
Formulation patent	Active ingredient, excipients, physical form or particle properties	Not claimed by this patent
Method-of-use patent	Treatment indication, dosing schedule or patient population	Not claimed by this patent
Manufacturing patent	Molding, assembly or coupling fabrication	Only relevant if separately claimed
Composition-of-matter patent	Chemical entity or salt	Not relevant to these claims

The patent creates device-layer protection. A generic drug manufacturer may avoid a formulation patent but still face infringement risk if it uses the claimed delivery device. Conversely, a device supplier may face risk even when the drug itself is off-patent.

What is the geographic coverage?

The claims apply only to the United States. Foreign family members may provide corresponding protection in Europe, the United Kingdom, Australia, Canada or other jurisdictions, but foreign claims, prosecution histories, term dates and enforceability may differ.

US 10,076,614 has no direct effect on sales conducted entirely outside the United States. It may still affect imported devices, US manufacturing, contract manufacturing and offers to sell in the United States under 35 U.S.C. § 271.[4]

What litigation and licensing risks exist?

The patent’s commercial value depends on whether the patented coupling is used in the marketed device and whether related family patents remain enforceable. A litigation review should examine:

USPTO Patent Center prosecution history.
Continuation and divisional applications.
Terminal disclaimers.
Inter partes review or post-grant review records.
Federal district court complaints and claim-construction orders.
Federal Circuit decisions.
FDA Orange Book entries and patent-use codes.
Commercial agreements assigning or licensing the device technology.

No conclusion about a settlement, license, or current litigation disposition follows from the claims alone. A settlement agreement could impose launch restrictions or covenants that are not visible in the patent text and may materially change generic-entry risk.

Key Takeaways

US 10,076,614 is a device patent covering an exhalation-powered nasal delivery system.
Claims 1 and 32 focus on asymmetric mouthpiece translation constrained by a flexible coupling.
The broadest risk does not depend on a particular drug, formulation or indication.
Dependent claims add sealing geometry, annular couplings, bowed profiles, graded elastomers, TPE durometer and quantitative movement ratios.
The patent’s expected unadjusted term extends into 2034, subject to USPTO term adjustments and other statutory modifications.
An Orange Book listing and Paragraph IV challenge cannot be established from the patent claims alone.
The main design-around options involve changing the coupling kinematics, movement ratio, mouthpiece architecture or nasal sealing arrangement.
Clearance requires review of the complete US family, continuations, FDA listings, litigation records and commercial agreements.

FAQs

Does US Patent 10,076,614 cover XHANCE?

The claims are technically consistent with an exhalation delivery system used for nasal drug administration, but the claims alone do not establish whether a particular marketed product practices every limitation or whether the patent is listed for that product.

Can a generic nasal spray avoid US Patent 10,076,614?

A conventional nasal spray that does not use the claimed housing, exhalation mouthpiece and asymmetrically translating flexible coupling may avoid the patent. A generic using a substantially similar exhalation delivery device requires a detailed infringement analysis.

Is US Patent 10,076,614 a drug patent or a medical-device patent?

It is a utility patent directed to a nasal delivery device. It does not claim a chemical compound, formulation or therapeutic method.

Do the 45-degree to 55-degree angle limits apply to every claim?

No. Those angular limitations appear in dependent claims 20-27 and 38-46. Claims 1 and 32 do not recite those specific angle ranges.

Can a company license the technology without licensing the drug?

In principle, device rights and drug rights can be licensed separately. The patent text does not identify the terms, scope or existence of any commercial license.

References

U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
United States Patent and Trademark Office. (2024). Patent term adjustment and patent term extension guidance.
U.S. Food and Drug Administration. (2024). Hatch-Waxman amendments and abbreviated new drug applications.
United States Code. (2024). 35 U.S.C. § 271: Infringement of patent.
U.S. Patent No. 10,076,614. (2018). Nasal delivery device. United States Patent and Trademark Office.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Azurity	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016		RX	Yes	Yes	10,076,614	⤷ Start Trial	Y				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

PCT Information
PCT Filed	February 25, 2013	PCT Application Number:	PCT/EP2013/053747
PCT Publication Date:	August 29, 2013	PCT Publication Number:	WO2013/124492

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013223973	⤷ Start Trial
Canada	2865353	⤷ Start Trial
China	104428026	⤷ Start Trial
Denmark	2817054	⤷ Start Trial
European Patent Office	2817054	⤷ Start Trial
Spain	2774159	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,076,614

Which drugs does patent 10,076,614 protect, and when does it expire?

Summary for Patent: 10,076,614