AIRDUO RESPICLICK Drug Patent Profile

Which patents cover Airduo Respiclick, and when can generic versions of Airduo Respiclick launch?

Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-six patent family members in thirty-five countries.

The generic ingredient in AIRDUO RESPICLICK is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Airduo Respiclick

A generic version of AIRDUO RESPICLICK was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for AIRDUO RESPICLICK

International Patents:	136
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	8
Drug Prices:	Drug price information for AIRDUO RESPICLICK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AIRDUO RESPICLICK
What excipients (inactive ingredients) are in AIRDUO RESPICLICK?	AIRDUO RESPICLICK excipients list
DailyMed Link:	AIRDUO RESPICLICK at DailyMed

See drug prices for AIRDUO RESPICLICK

Pharmacology for AIRDUO RESPICLICK

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for AIRDUO RESPICLICK

AIRDUO RESPICLICK is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	Yes					Y

Expired US Patents for AIRDUO RESPICLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017

EU/EMA Drug Approvals for AIRDUO RESPICLICK

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Airexar Spiromax	salmeterol xinafoate, fluticasone propionate	EMEA/H/C/004267Airexar Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1	Withdrawn	no	no	no	2016-08-18

International Patents for AIRDUO RESPICLICK

See the table below for patents covering AIRDUO RESPICLICK around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2011254958
Brazil	112012029106
Canada	2799625
Canada	2887315
Canada	2936362
Canada	3019694
Canada	3111537

Supplementary Protection Certificates for AIRDUO RESPICLICK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527

AirDuo RespiClick (fluticasone propionate + salmeterol) Market Dynamics and Financial Trajectory: Exclusivity, Competitive Risks, and Revenue Outlook

Last updated: July 21, 2026

AirDuo RespiClick (fluticasone propionate [FP] 55 mcg + salmeterol xinafoate [SL] 14 mcg, inhalation powder) is an established U.S. fixed-dose combination (FDC) inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) franchise in asthma and COPD. Commercial momentum is driven by (1) durability of the device-led brand presence, (2) payer and formulary positioning versus FDC competitors (especially Advair Diskus/HFA, Breo Ellipta, and Symbicort/Dulera combinations), and (3) the pace of genericization and biosimilar-style substitution risk (for inhalers, the analogue is multi-source generics and device equivalency). Patent and exclusivity headwinds determine how much share erosion can be expected and when generic entry becomes structurally harder to prevent.

How does AirDuo RespiClick compete in the ICS/LABA market and what drives share?

Featured snippet answer: AirDuo RespiClick competes primarily on formulary tier placement, patient-device preference, and total cost, with share influenced by the competitor set across diskus-style devices (Advair), ellipta devices (Breo), and metered-dose inhalers (Symbicort/Dulera). Long-term outcomes track payer switching patterns after key patent/exclusivity milestones.

Where does AirDuo RespiClick sit in the ICS/LABA competitive set?

• Direct FDC class competitors (U.S.):
  • GlaxoSmithKline (GSK) Advair Diskus and Advair HFA (FP/SL)
  • AstraZeneca Breo Ellipta (fluticasone furoate/vilanterol, FF/VI)
  • AstraZeneca Symbicort (budesonide/formoterol, BUD/FORM)
  • Merck Dulera (mometasone/formoterol, MBR/FORM)
  • TEVA/others for generic ICS/LABA where available by molecule and dose
• Key commercial reality: ICS/LABA is a mature category with high class churn. Brands defend share through contracting and patient adherence linked to device usability. AirDuo’s RespiClick is a breath-actuated dry powder device; in practice, differentiation is less about molecule novelty and more about contracting and switching friction.

What market dynamics most affect AirDuo RespiClick pricing and volumes?

1. Formulary placement and PBM contracting
   • Tiering (preferred vs non-preferred) and prior authorization requirements typically explain a large share of net sales variance across ICS/LABA inhalers.
2. Generic entry and “same molecule, same therapy” substitution
   • Where generic FP/SL combinations are available (and payer policies allow), brands lose protected market position quickly.
3. Device-level switching and persistence
   • Patients often stay within a device class if they have low intolerance and good technique. Payers exploit this by pushing lower net-cost products.
4. Seasonality and guideline-driven prescribing
   • Asthma control cycles and COPD exacerbation windows influence prescription and refill behavior.

How does FDA indication scope change AirDuo’s commercial exposure?

• AirDuo is marketed for asthma (ICS/LABA maintenance) and typically aligns with the broader ICS/LABA guideline base.
• COPD exposure is generally constrained by the number and specifics of labeled COPD regimens and local payer coverage; COPD dosing patterns also shift with competitor FF/VI and other LABA/ICS products.

What is the financial trajectory for AirDuo RespiClick: growth drivers and erosion mechanisms?

Featured snippet answer: AirDuo RespiClick’s financial trajectory tracks two forces: (1) incremental share retention versus Advair and other branded ICS/LABA, and (2) net price and volume pressure as generics and competing devices gain formulary leverage.

Growth drivers (where revenue can keep holding up)

• Device stickiness and adherence
  • RespiClick’s breath-actuated powder format can support persistence when patients prefer the workflow and feel it is effective.
• Contracted access in commercial insurance
  • Preferred placement in key PBMs and regional plans can protect net sales even after molecule-level commoditization pressures increase.
• Differentiated patient support
  • Inhaler coaching and refill programs can reduce churn, which matters in a class with many interchangeable options.

Revenue erosion mechanisms (how net sales typically decline in this class)

• Step therapy
  • Payers often require demonstration of use of cheaper alternatives before approving certain branded combinations.
• Switching after utilization management changes
  • A change in formulary design or prior authorization criteria can trigger rapid share losses across an ICS/LABA product family.
• Competitive net price compression
  • After genericization of key competitors, branded manufacturers price-discount more aggressively to avoid volume loss.

What financial line items matter most for inhaler brands like AirDuo?

• Net sales, not gross
  • Inhalers are discount-heavy: rebates, chargebacks, and PBM fees drive the spread between list price and realized revenue.
• Prescription volume and persistence
  • The category is refill-led; erosion is usually a persistence problem before it is a prescribing problem.
• Mix by strength/dosing regimen
  • Higher strength and dosing convenience (per-device regimen fit) can improve realized net sales even with flat units.

When does AirDuo RespiClick face exclusivity or patent loss pressure and how does that translate to generic entry risk?

Featured snippet answer: Generic entry risk for AirDuo is tied to the latest active U.S. patent barriers and any remaining exclusivities tied to the application and listed patents on the FDA Orange Book. Once those barriers clear, Paragraph IV and “skinny” or device/route workarounds can accelerate substitution.

Orange Book and patent estate logic for inhaler FDC brands

AirDuo’s generic risk profile is usually determined by:

• Composition of matter (FP/SL or salt/combination coverage)
• Formulation patents (particle engineering, stabilizers, moisture protection, dose uniformity)
• Device-related patents (inhalation powder device mechanisms, dose counter, inhaler housing)
• Method-of-use patents (asthma/COPD dosing regimens or patient subsets)

Commercial implication: if the last remaining enforceable patents are formulation or device patents, generic challengers may file with alternative manufacturing or device designs. If the enforceable patents are composition-of-matter, entry is often delayed until those expire or are designed around successfully.

How to map patent expiration into a revenue timeline

A practical revenue risk model for AirDuo typically follows:

1. Patent expiry windows
   • Heightened uptake by competitor generics and accelerated PBM contracting planning.
2. Paragraph IV litigation cycles
   • Settlement timing determines the practical “launch date” more than the legal expiration date.
3. Post-launch erosion curve
   • ICS/LABA inhalers often show rapid early share loss followed by stabilization depending on patient persistence and formulary design.

Which patents protect AirDuo RespiClick and how strong is the estate?

Featured snippet answer: The strength of the AirDuo patent estate is best evaluated by Orange Book-listed drug-product and method patents, including their remaining term, claim scope (formulation vs device vs method-of-use), and history of Paragraph IV litigation or settlements.

What to look for in AirDuo’s patent coverage

• Drug substance coverage
  • FP and SL combination claims
• Drug product coverage
  • inhalation powder composition, excipients, particle size distribution, moisture/flow stability
• Device coverage
  • RespiClick-specific mechanisms and dose delivery structure
• Use coverage
  • dosing schedule or therapeutic method claims for asthma/COPD management

What makes inhaler patent estates commercially potent

• Device or formulation claims can block “easy” generic copy even if composition is off-patent.
• Method-of-use claims can force generics into label workarounds or reduce uptake if payers require matching indication language.

Have there been Paragraph IV challenges to AirDuo RespiClick and what litigation affects entry timing?

Featured snippet answer: Generic entry timing is driven by whether challengers file Paragraph IV certifications against Orange Book-listed patents, the outcome of any litigation, and whether a final judgment or settlement triggers a shared launch date.

What litigation outcomes usually do to inhaler revenue

• Court win for brand
  • Delays generic entry and extends contracting leverage.
• Settlements
  • Create a defined “carve-out” launch window, often limiting the number of generic entrants or delaying a specific strength.
• Court loss for brand
  • Accelerates market erosion and compresses net pricing quickly.

What is the Orange Book status of AirDuo RespiClick and what generic entry risks exist for patients and payers?

Featured snippet answer: Orange Book status determines the legal gating items: listed patents that are actively enforceable constrain generic entry and dictate whether challengers can launch at risk or must wait.

Generic entry risks after legal clearance

• Entry at lower net cost
  • PBMs and retail channels shift to multi-source products quickly after barriers clear.
• Device substitution dynamics
  • If a generic uses a comparable dry powder device, patient switching becomes more feasible; if it requires a different device type, uptake can slow due to technique friction.

How does AirDuo RespiClick compare with Advair Diskus, Breo Ellipta, and other ICS/LABA brands on market performance?

Featured snippet answer: AirDuo’s market performance is shaped by the relative strength of entrenched leaders (Advair/Breo) and by whether its net price and formulary access remain competitive versus those leaders and generic alternatives.

Competitive differences that impact sales

• Molecule class
  • FP/SL (AirDuo/Advair) vs FF/VI (Breo) can affect prescriber preference and patient response.
• Device
  • Advair Diskus (dry powder), Breo Ellipta (dry powder), Symbicort/Dulera (MDI). Device preference influences persistence.
• Formulary inertia
  • Leaders often retain preferred status through multi-year rebate agreements and contract continuity.

Where is AirDuo RespiClick most exposed to revenue decline: dosing strengths, indications, or channels?

Featured snippet answer: Revenue exposure typically concentrates in the strengths with the highest volume share on payer formularies and in commercial retail channels where PBM formulary design drives rapid switching.

Channel sensitivity

• Commercial insurance
  • Most sensitive to PBM tiering and preferred networks.
• Medicaid
  • Often more sensitive to lowest-cost contracting and state-level preferences.
• Medicare
  • Depending on Part D plan formularies, can shift later than commercial but can still trigger erosion once generics are priced aggressively.

Indication sensitivity

• If asthma maintenance is the primary sales driver, erosion risk rises when competing ICS/LABA products become preferred in asthma guidelines or payer criteria.
• COPD-labeled demand can be smaller or more variable and may shift with competitor FF/VI performance and PBM coverage.

Which companies are likely to gain market share from AirDuo after patent/market clearance?

Featured snippet answer: In ICS/LABA, generic manufacturers and inhaler portfolio competitors generally capture share first in the most straightforward “same molecule, same class” substitutions, subject to device fit and formulary access.

Typical post-barrier entrants

• Multi-source generic manufacturers with capacity for dry powder inhaler production and strong rebate leverage
• Branded competitors that use net-price discounts to remain preferred when brand-level patent leverage weakens

Key Takeaways

• AirDuo RespiClick competes in a mature ICS/LABA market where formulary contracting, device persistence, and generic substitution drive outcomes more than clinical differentiation.
• Financial trajectory is shaped by patent and Orange Book gating barriers; practical generic launch timing depends on litigation and settlement cycles, not just calendar expiry.
• Revenue risk accelerates after legal clearance, with rapid early share loss driven by PBM tiering and patient switching feasibility.
• Competitive pressure is dominated by FP/SL peers (Advair) and adjacent ICS/LABA brands (Breo, Symbicort/Dulera), with generic multi-source products determining the long-run net price floor.

FAQs

1. What makes inhaler net sales fall faster than tablet generics once exclusivity ends?
   Rebate and formulary switching can move volumes quickly because inhalers are routinely interchangeable within ICS/LABA classes and persistence can be influenced by device usability and payer restrictions.

2. Do inhaler device differences slow generic uptake after patent expiry?
   Often. Dry powder versus MDI formats and user technique requirements can delay switching, but PBM incentives usually offset technique barriers over time.

3. What is the biggest determinant of AirDuo’s remaining brand value: patents on formulation or device?
   Device and formulation patents are commercially decisive when they make “drop-in” copying impractical or require redesign that slows approvals and raises cost.

4. How do Paragraph IV settlements affect revenue timing for AirDuo?
   Settlements can create a defined launch window, limit the number of entrants, and delay the start of price erosion despite earlier patent expiry dates.

5. Which payer mechanisms most reduce AirDuo prescriptions?
   Preferred tier moves, prior authorization, and step therapy typically drive measurable utilization shifts within one to two formulary cycles.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drug Trials Snapshots: Inhalation products and labeling information. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots