Details for Patent: 9,415,008

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Which drugs does patent 9,415,008 protect, and when does it expire?

Patent 9,415,008 protects AIRDUO DIGIHALER and AIRDUO RESPICLICK and is included in one NDA.

Protection for AIRDUO DIGIHALER has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty patent family members in seventeen countries.

Summary for Patent: 9,415,008

Title:	Dry powder inhaler
Abstract:	This invention provides a dry powder inhaler comprising: a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of fluticasone propionate per actuation is less than 100 μg; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose. A method of treating a patient includes administering to a patient a dry powder medicament having fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of fluticasone propionate per actuation is less than 100 μg; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose.
Inventor(s):	Mukul DALVI, Seah Kee TEE
Assignee:	Teva Branded Pharmaceutical Products R&D Inc
Application Number:	US15/001,853
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,415,008
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

US Patent 9,415,008: Claim Scope, Expiration Framework, Litigation Risk, and Fluticasone/Salmeterol Patent Landscape

US Patent 9,415,008 covers a low-dose dry powder inhaler containing fluticasone propionate, salmeterol xinafoate, and lactose. Its principal limitation is a functional performance requirement: less than 100 micrograms of fluticasone propionate per actuation must produce a baseline-adjusted FEV1 improvement of more than 150 mL within 30 minutes. Dependent claims add dose levels, particle-size distributions, lactose engineering, cyclone deagglomeration, reservoir metering, and specific inhaler architecture.

The patent is strategically important because it combines three protection layers:

1. A low-dose fluticasone/salmeterol formulation.
2. A performance-defined method of treatment.
3. A device architecture directed to powder dispersion and metering.

The broadest commercial risk is concentrated in claims 1 and 17. The strongest technical enforcement positions are likely claims 5-14, provided the accused product contains the specified particle, carrier, deagglomeration, or reservoir features.

What does US Patent 9,415,008 cover?

The patent covers both an inhaler and a treatment method.

Claim group	Subject matter	Commercial relevance
Claims 1-16	Dry powder inhaler containing fluticasone propionate, salmeterol xinafoate, and lactose	Product infringement
Claims 2-9	Duration, dose, particle size, and lactose-carrier limitations	Formulation and performance differentiation
Claims 10-14	Cyclone deagglomerator, reservoir, passageway, and metering mechanisms	Device and delivery-system protection
Claim 15	Use for asthma or COPD	Intended-use limitation
Claims 17-20	Treatment of asthma, allergic rhinitis, or COPD using the low-dose combination	Method-of-use infringement

Claim 1 requires every limitation in combination. A product containing fluticasone propionate and salmeterol is not within claim 1 unless it also uses lactose as a carrier, delivers less than 100 micrograms of fluticasone per actuation, and satisfies the FEV1 performance limitation.

How broad is independent claim 1?

Claim 1 is narrower than a conventional composition claim because it requires both a specific inhaler configuration and a clinical or pharmacodynamic outcome.

The required elements are:

1. A dry powder inhaler.
2. A dry powder medicament.
3. Fluticasone propionate.
4. Salmeterol xinafoate.
5. A lactose carrier.
6. Less than 100 micrograms of delivered fluticasone propionate per actuation.
7. Baseline-adjusted FEV1 above 150 mL within 30 minutes.

The claim does not require a specific device brand, a specific total powder mass, a particular nominal dose, or a particular lactose grade unless those limitations appear in a dependent claim.

The FEV1 limitation materially narrows claim 1. It is not merely a statement of intended use. It describes an objectively measurable treatment result. An accused product could contain the same ingredients and dose but avoid infringement if the claimed FEV1 result cannot be established under the claim’s required conditions.

The claim also raises construction issues:

• “Delivered dose” may refer to the dose emitted from the inhaler or the dose reaching the patient, depending on the specification and prosecution history.
• “Baseline-adjusted FEV1” requires a defined baseline and a defined measurement protocol.
• “In a patient” does not identify disease severity, age, baseline lung function, concomitant therapy, or statistical population.
• “Within 30 minutes” creates a time-specific performance requirement.
• The claim does not specify whether the result must occur in every treated patient or in a clinical-study population.

Those issues would likely control infringement and validity disputes.

What do claims 2-4 and 16 protect?

Claims 2-4 and 16 narrow the low-dose regimen.

Claim	Limitation
2	FEV1 remains above 150 mL for at least six hours
3	Fluticasone dose below 75 micrograms
4	Fluticasone/salmeterol dose of 50/12.75 or 25/12.75 micrograms
16	Fluticasone/salmeterol dose of 49/12.75 micrograms

The 49/12.75 and 50/12.75 formulations are commercially significant because they are close enough to create dose-equivalence disputes. A manufacturer could market a formulation at a nominal 50-microgram dose while reporting a delivered dose below 50 micrograms. In an infringement case, the controlling question would be how the patent defines and measures the delivered dose.

Claim 4 uses two specific dose combinations, while claim 16 adds a separate 49/12.75 combination. A product at 55/14, 100/50, 250/50, or 500/50 would not literally satisfy those exact dependent-claim dose limitations, although it could still implicate claim 1 if the delivered fluticasone dose remains below 100 micrograms.

What formulation characteristics are protected?

Claims 5-9 target particle engineering and the lactose carrier.

Fluticasone particle size

Claim 5 specifies:

• d10: 0.4-1.1 micrometers
• d50: 3.0-11.1 micrometers, based on the stated range
• d90: 2.6-7.5 micrometers
• At least 95% below 10 micrometers
• Measurement by laser diffraction as an aqueous dispersion

The claim text presents the d50 range in descending order as “11.1-3.0.” It would normally be read as a range bounded by 3.0 and 11.1 micrometers, subject to the patent’s specification and prosecution history.

The measurement medium matters. Particle-size results obtained by laser diffraction in aqueous dispersion may differ from measurements obtained by dry dispersion, microscopy, cascade impaction, or aerodynamic sizing. A competing product could therefore create a dispute over both the numerical result and the appropriate test method.

Salmeterol particle size

Claim 6 specifies:

• d10: 0.4-1.3 micrometers
• d50: 1.4-3.0 micrometers
• d90: 2.4-6.5 micrometers
• At least 95% below 10 micrometers
• Measurement by laser diffraction as an aqueous dispersion

The claim text contains the typographical form “dl 0,” which would ordinarily be interpreted as d10 if supported by the specification.

Lactose carrier

Claims 7-9 cover a multimodal lactose carrier:

• Coarse lactose
• Fine lactose below 10 micrometers
• Fine lactose at 1-10 weight percent
• Coarse lactose with d10 of 15-50 micrometers
• d50 of 80-120 micrometers
• d90 of 120-200 micrometers

These claims are more readily investigated through formulation analytics than claim 1. Particle-size distribution, lactose fraction, and carrier morphology can be evaluated from retained samples or regulatory-quality batch records. They may create risk even where the active pharmaceutical ingredients and nominal dose differ from the reference product.

What inhaler-device features are protected?

Claims 10-14 create a separate device-focused layer.

Cyclone deagglomerator

Claims 10 and 11 cover a cyclone or swirl-based deagglomerator with:

• An inner wall defining a swirl chamber
• A first and second end
• A dry-powder supply port
• One or more inlet ports
• An outlet port
• Radially extending vanes
• Oblique vane surfaces
• Breath-induced pressure that draws air through the supply and inlet ports

This language is directed to the internal airflow path rather than the external appearance of the inhaler. A design-around could use a mesh, impaction surface, turbulent chamber, vibrating element, or alternative deagglomeration geometry, but the resulting structure would need to be compared against each limitation.

Reservoir and metering system

Claims 12-14 cover:

• A medicament reservoir
• A metering arrangement
• A sealed reservoir
• A dispensing port
• A channel with a pressure-relief port
• A conduit connecting the reservoir interior to the pressure-relief port
• A movable cup assembly
• Separate sealing surfaces for the dispensing and pressure-relief ports

These claims are particularly relevant to multidose reservoir inhalers. They are less likely to read on a conventional blister-strip inhaler unless the accused product includes equivalent structural elements.

What do the method claims protect?

Claims 17-20 cover treatment methods using the same low-dose combination.

The method claims require:

• Administration to a patient
• Asthma, allergic rhinitis, or COPD
• Fluticasone propionate
• Salmeterol xinafoate
• Lactose carrier
• Less than 100 micrograms of fluticasone per actuation
• FEV1 improvement exceeding 150 mL within 30 minutes

Claims 18-20 narrow the method to less than 75 micrograms and the 50/12.75, 25/12.75, or 49/12.75 dose combinations.

Method claims create different enforcement economics from product claims. A manufacturer generally does not directly administer the product. Liability analysis can instead focus on prescribing information, promotional materials, clinical protocols, labeling, distributor conduct, and induced-infringement theories. A label limited to a nonclaimed use may reduce method-of-use risk but does not eliminate product-claim exposure.

When does US Patent 9,415,008 lose exclusivity?

The statutory term for a patent issuing from a nonprovisional application filed after June 8, 1995, is generally 20 years from the earliest effective nonprovisional filing date, subject to terminal disclaimers, patent-term adjustment, patent-term extension, and other adjustments under 35 U.S.C. §§ 154 and 156.

The grant date, August 16, 2016, does not determine expiration. A reliable expiration date requires:

• The earliest effective nonprovisional filing date
• Any priority claims
• Patent-term adjustment
• Patent-term extension
• Terminal-disclaimer status
• Continuation or divisional relationships

The patent record and USPTO Patent Center should control the operative date. The Orange Book controls listed drug-related patent information for an approved product, but it does not independently establish the full expiration analysis for every patent claim.[1][2]

What is the Orange Book status and FDA relevance?

Fluticasone propionate/salmeterol is associated with GlaxoSmithKline’s Advair Diskus and Advair HFA products. Advair Diskus is a dry powder product containing fluticasone propionate and salmeterol, while Advair HFA uses a metered-dose inhaler.[3]

The FDA-approved U.S. strengths for Advair Diskus are generally 100/50, 250/50, and 500/50 micrograms per blister, expressed as fluticasone propionate/salmeterol. Those strengths do not directly match the 25/12.75, 49/12.75, or 50/12.75 doses in Patent 9,415,008.

The patent therefore appears more closely aligned with a low-dose inhaler platform or a particular regional product configuration than with the standard U.S. Advair Diskus strengths. A product may be relevant to the patent even if it is not listed in the Orange Book against Advair. Conversely, a patent may be listed against an NDA without every claim reading on every strength or device configuration.

FDA-approved competitive products include:

• Advair Diskus and Advair HFA, GSK
• Wixela Inhub, Viatris, an authorized generic or substitutable fluticasone propionate/salmeterol product in the U.S. market[4]
• AirDuo RespiClick and AirDuo Digihaler, Teva, using fluticasone propionate and salmeterol with different device and dose configurations[5]

The AirDuo products are especially relevant to claim-charting because they use lower fluticasone strengths than traditional Advair Diskus. Their device architecture, delivered-dose data, carrier system, and particle-size specifications would determine whether claims 1, 3, 4, 5, 7, or 10-14 are implicated.

Which companies are potential challengers?

The principal competitive parties are:

Company	Relevant product or role	Primary risk issue
GSK	Advair Diskus and Advair HFA	Reference-product and legacy patent estate
Viatris/Mylan	Wixela Inhub	Generic or substitutable dry-powder competition
Teva	AirDuo RespiClick and Digihaler	Low-dose fluticasone/salmeterol and proprietary devices
Contract manufacturers	API, lactose, and inhaler-device suppliers	Access to formulation and manufacturing know-how
Regional manufacturers	Seretide/Flutiform-type markets outside the U.S.	Geographic claim and regulatory differences

Paragraph IV exposure depends on whether Patent 9,415,008 is listed for the relevant reference product and whether a generic applicant seeks approval for a strength or indication that falls within the listed claims. A Paragraph IV certification against an Orange Book-listed patent can trigger a 30-month stay under the Hatch-Waxman framework, subject to statutory exceptions and litigation events.[2]

No conclusion about a current Paragraph IV challenge, settlement, or litigation outcome follows from the claim text alone. Those matters require review of FDA listing records, ANDA notices, PACER dockets, and settlement filings.

How strong is the patent estate?

The estate is mixed rather than uniformly strong.

Stronger features

• Specific particle-size ranges
• Quantified fine-lactose content
• Defined coarse-lactose distribution
• Detailed cyclone-deagglomerator geometry
• Detailed reservoir and cup-metering structure
• Specific low-dose combinations

These limitations can distinguish over broad fluticasone/salmeterol prior art if supported by the patent specification and prosecution record.

Vulnerable features

• FEV1 above 150 mL may raise enablement and written-description issues across all claimed formulations.
• The claim does not define the clinical population or testing protocol.
• “Delivered dose” may be disputed.
• The particle-size limitations use measurement methods that may produce different results across laboratories.
• Claims 1 and 17 combine formulation, dose, device, and clinical-performance limitations, creating potential anticipation and obviousness combinations.
• Claims 10-14 may face substantial prior art from inhaler-device patents if the structures were known before the priority date.

The most credible validity attack would likely combine earlier fluticasone/salmeterol formulations with prior art covering lactose carriers, low-dose delivery, and inhaler deagglomeration. The patent owner’s response would depend on unexpected clinical performance, dose reduction, particle engineering, and the specific interaction between formulation and device.

What generic launch scenarios exist?

A competitor has four principal design-around paths:

1. Use a different fluticasone dose outside the claimed range.
2. Replace lactose with another carrier or use a materially different carrier distribution.
3. Use a different deagglomeration or metering architecture.
4. Avoid the claimed clinical use or dose instructions while pursuing a different regulatory pathway.

The most practical route is likely a combination of device substitution and formulation changes. Changing only the nominal dose may not avoid claim 1 if the delivered dose remains below 100 micrograms. Changing only the inhaler may not avoid claim 17 because the method claims do not expressly require the cyclone or reservoir limitations.

Key Takeaways

• Patent 9,415,008 targets low-dose fluticasone propionate/salmeterol dry powder delivery.
• Claims 1 and 17 are the principal commercial claims.
• Claims 5-9 protect particle-size and lactose-carrier characteristics.
• Claims 10-14 protect specific inhaler airflow, reservoir, and metering structures.
• The FEV1 requirement is central to both scope and validity.
• Standard U.S. Advair strengths do not directly match the patent’s 25/12.75, 49/12.75, and 50/12.75 dose limitations.
• AirDuo and Wixela are key competitive products for claim charting.
• Patent expiration cannot be fixed from the grant date; the earliest effective filing date, PTA, PTE, and terminal disclaimer must control.
• A Paragraph IV, settlement, or litigation conclusion requires current FDA and court-record review.

FAQs

Does Patent 9,415,008 cover all fluticasone/salmeterol inhalers?

No. The product claims require lactose, a low delivered fluticasone dose, and the claimed FEV1 result. Dependent claims add specific particle, carrier, and device limitations.

Does a 100/50 Advair-type product fall within the low-dose claims?

Not automatically. The relevant measurement is delivered fluticasone per actuation, not simply the labeled or nominal strength. The FEV1 limitation must also be satisfied for claim 1.

Can a lactose-free fluticasone/salmeterol inhaler avoid the patent?

It would likely avoid claims requiring a lactose carrier, but it could still require analysis under any broader related patent claims or method claims if the formulation actually contains lactose.

Are claims 10-14 limited to a specific inhaler brand?

No. They are structural claims. Any inhaler can potentially fall within them if its internal airflow, reservoir, pressure-relief, cup, and sealing structures meet the limitations.

Is Patent 9,415,008 a biologic or biosimilar patent?

No. It covers a small-molecule inhaled combination product. Biosimilar rules do not apply. Competitive products proceed through generic, hybrid, or other FDA drug-approval pathways rather than the biosimilar pathway.

References

1. United States Patent and Trademark Office. (n.d.). U.S. Patent No. 9,415,008. https://patents.google.com/patent/US9415008B2/en
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files
3. U.S. Food and Drug Administration. (n.d.). Advair Diskus prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/
4. U.S. Food and Drug Administration. (2019). Wixela Inhub approval information. https://www.fda.gov/drugs
5. U.S. Food and Drug Administration. (n.d.). AirDuo RespiClick and AirDuo Digihaler prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/
6. United States Code. (2024). 35 U.S.C. §§ 154-156: Patent term and patent-term extension. https://uscode.house.gov/ 񟿿

Drugs Protected by US Patent 9,415,008

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	Yes					Y

International Family Members for US Patent 9,415,008

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	104771
Australia	2016209363
Australia	2021202784