ARMONAIR RESPICLICK Drug Patent Profile

When do Armonair Respiclick patents expire, and when can generic versions of Armonair Respiclick launch?

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

This drug has eighty-six patent family members in thirty countries.

The generic ingredient in ARMONAIR RESPICLICK is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Armonair Respiclick

A generic version of ARMONAIR RESPICLICK was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for ARMONAIR RESPICLICK

International Patents:	86
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	81
Patent Applications:	2,700
Drug Prices:	Drug price information for ARMONAIR RESPICLICK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARMONAIR RESPICLICK
DailyMed Link:	ARMONAIR RESPICLICK at DailyMed

See drug prices for ARMONAIR RESPICLICK

US Patents and Regulatory Information for ARMONAIR RESPICLICK

ARMONAIR RESPICLICK is protected by two 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	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-007	Jul 9, 2021		DISCN	Yes	No	11,969,544*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017		DISCN	Yes	No	10,195,375*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017		DISCN	Yes	No	11,969,544*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017		DISCN	Yes	No	11,969,544*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-007	Jul 9, 2021		DISCN	Yes	No	10,195,375*PED				Y

Expired US Patents for ARMONAIR RESPICLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	6,701,917
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017	8,006,690
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017	6,701,917
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017	6,446,627
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	6,748,947

International Patents for ARMONAIR RESPICLICK

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

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

Supplementary Protection Certificates for ARMONAIR 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

Armonair RespiClick market dynamics and financial trajectory (sales, pricing, exclusivity, and competitive threats)

Last updated: July 29, 2026

Armonair RespiClick (flunisolide) sits in the inhaled corticosteroid (ICS) segment for asthma. Commercial momentum has been shaped by: (1) loss of brand exclusivity for flunisolide products years earlier, (2) steady competitive pressure from multi-source generics and alternative ICS/LABA regimens, and (3) channel dynamics typical for legacy respiratory brands after payer formulary normalization to low-cost options. The result is a lower-margin, declining-or-flat brand profile, with residual demand concentrated in formulary niches, step-therapy pathways, and cost-managed contracting.

Armonair RespiClick’s core value proposition has been delivery system convenience (dry powder inhaler) and dosing continuity for patients transitioned to or maintained on flunisolide. Over time, that profile has narrowed as prescribers and payers favored either cheaper flunisolide alternatives or higher perceived efficacy classes (especially ICS plus LABA fixed combinations) where formularies allow.

What is Armonair RespiClick and what drives demand in asthma inhaled corticosteroids?

Quick product snapshot

• Product: Armonair RespiClick
• Active ingredient: Flunisolide (inhaled corticosteroid, ICS)
• Formulation/delivery: Dry powder inhaler (RespiClick platform)
• Therapeutic use: Asthma control (maintenance; anti-inflammatory)

Key demand drivers

1. Formulary placement for ICS monotherapy
   Where payers reduce coverage for brand ICS products and steer to generics, demand shifts to lowest-net-cost options.
2. Step-therapy behavior
   Patients often start on guideline-preferred ICS choices and then escalate to ICS/LABA if control is inadequate. That dynamic compresses addressable demand for ICS monotherapy brands.
3. Patient-device fit and continuity of therapy
   RespiClick convenience can reduce adherence friction for some patients, sustaining a base of users even under heavy generic competition.
4. Local contracting and rebate structures
   In legacy respiratory franchises, net pricing tends to decline faster than list price due to rebate growth and payer carve-outs for cheaper alternatives.

How has Armonair RespiClick’s pricing and net revenue trended under generic competition?

Armonair RespiClick’s financial trajectory is typically consistent with other legacy inhaled brands once flunisolide competition expands: list prices may remain stable or drift modestly, while net revenue declines from (a) increasing share loss to generics, (b) payer-driven price pressure, and (c) higher rebate requirements to hold placement.

Commercial pattern in legacy inhaled steroids

• Gross-to-net erosion: rebates increase as formularies normalize to multi-source ICS options
• Channel pressure: wholesalers and PBMs push for lowest AWP-derived pricing and tender-based rebates
• Brand lifecycle effect: as clinicians and formularies switch to cheaper maintenance regimens, volumes stabilize at a lower baseline

Implication for financial trajectory

• The likely profile is flat-to-declining unit volume with net revenue per unit under pressure, producing a gradual margin compression even if prescriptions persist among resistant formulary segments.

When does Armonair RespiClick lose exclusivity, and how does that affect financial performance?

Armonair RespiClick’s market dynamics are dominated by the reality that flunisolide is an older, multi-source active ingredient. For the specific commercial product:

• Brand exclusivity effects (if any remaining) would have been limited, and any meaningful revenue protection would come from late-expiring patents tied to the specific formulation/device and labeled use.
• Once those protections expired, generic entry becomes a primary driver of share and net price declines.

Exclusivity and patent-driven expectations

• For older ICS actives, the biggest revenue inflection usually occurs at the combination of:
  1. initial patent expiry for the brand product’s specific claims, and
  2. the ramp of multi-source inhaled competitors after approvals.

This pattern drives the typical “new entry shock then long tail” seen in legacy respiratory brands: a rapid drop around competitive entry, then stabilization at a residual base.

What patent estate and Orange Book status governs generic entry risk for Armonair RespiClick?

Armonair RespiClick is a small-molecule product with route-of-administration and formulation/device-related IP that would show up in the FDA Orange Book as patents associated with the NDA.

For a precise mapping of:

• each listed patent,
• expiration dates,
• and any “Paragraph IV” certifications driving litigation,

a current Orange Book record is required. Without a cited, record-level Orange Book listing, a complete and accurate patent-expiration and litigation-risk timeline cannot be produced here.

How many competitors target asthma control with ICS therapy, and how does that shape Armonair RespiClick’s share?

Armonair RespiClick faces competitive pressure on multiple dimensions:

1. Generic flunisolide alternatives
   Same active class, same therapeutic positioning, lower price.

2. Other ICS brands and multi-source ICS
   Even when the active ingredient differs, payers can substitute across ICSs through formulary interchange.

3. ICS/LABA fixed combinations
   These often win on perceived outcomes and guideline alignment for patients requiring escalation, pulling demand away from ICS-only regimens.

4. Patient and prescriber switching friction
   Device mismatch can reduce switching, but in many cases step-up or step-down therapy is managed by clinicians based on control status.

Net effect on market dynamics

• Armonair RespiClick’s addressable market shrinks as payer step-therapy policies and competitive substitution reduce monotherapy share.

Which companies market flunisolide or compete directly in ICS asthma, and how does that affect economics?

Direct competitors typically include:

• manufacturers of generic flunisolide inhalation products,
• multi-source ICS inhalers (various actives),
• and branded or generic ICS/LABA combinations.

However, a company-by-company competitive table with verified products, label indications, and current FDA approvals requires Orange Book and FDA product database cross-checking that is not possible within this response without cited record-level sources.

What litigation and Paragraph IV challenges affect Armonair RespiClick revenue?

Paragraph IV challenges are a key channel for generic entry risk. The magnitude of revenue impact depends on:

• timing relative to patent expiry,
• whether a first generic filer settles,
• and whether additional challengers launch concurrently.

A complete litigation map (case captions, court, filing dates, settlement dates, and resulting entry timing) requires verified docket-level or press-release-level sources for Armonair RespiClick. Those record-level facts are not supplied here, so a complete and accurate litigation timeline cannot be produced.

How does FDA status and the approval landscape affect Armonair RespiClick’s commercial trajectory?

FDA approval pathways matter in two ways

1. Generic approvals: Once generics can rely on bioequivalence and enter, they compress brand share and net pricing.
2. Device/formulation changes: If the brand’s delivery system claims are the competitive differentiator, regulatory changes and alternative generic device profiles can weaken that moat.

A precise status review (NDA details, listed strengths, any supplement activity, and generic approvals) requires FDA reference lookups tied to Armonair RespiClick’s specific NDA and associated ANDAs. Without those cited sources, a complete “regulatory status” section cannot be reliably assembled.

What generic entry scenarios exist for Armonair RespiClick, and what is the expected revenue impact?

For legacy ICS brands, typical entry scenarios follow a predictable market economics pattern:

1. Single generic entry

   • Rapid share shift from brand
   • Net price reductions via rebate rebalancing
   • Brand revenue declines but may stabilize if a payer keeps a niche position

2. Multiple generic entries

   • Further net pricing compression
   • Increased wholesaler and PBM tender pressure
   • Residual brand demand concentrates in less price-sensitive segments

3. Device substitution

   • If generics use different device profiles, a portion of patient base can remain
   • If device interchange is accepted, brand retention drops

Expected trajectory

• Post-entry, revenue generally declines more sharply than unit prescriptions due to gross-to-net erosion, then plateaus at a smaller base.

How does Armonair RespiClick compare with other inhaled corticosteroid products in financial resilience?

Relative resilience in ICS depends on:

• brand differentiation (device, dosing convenience),
• payer contract strength,
• ability to maintain formulary placement,
• and whether patients are locked into the delivery system.

Armonair RespiClick’s resilience is constrained by the shared class substitution logic:

• even if device friction exists, payer formularies often permit interchange within ICS classes;
• and cost pressure pushes toward lowest net-cost options.

The typical result in this category is modest remaining brand revenue after generic penetration rather than a sustained brand-like growth profile.

Regional and channel dynamics: where does Armonair RespiClick hold demand?

In asthma maintenance markets, demand usually concentrates based on:

• Medicaid and commercial formulary formularies,
• plan-specific tendering,
• and geographic prescribing patterns for asthma specialists vs primary care.

A region-level breakdown cannot be cited without claims/market data sources (IQVIA, Medicaid formularies, PBM plan matrices) and without those data being supplied here.

Financial trajectory summary: what does the market position imply for revenue, margin, and lifecycle risk?

Executive view

• Lifecycle stage: mature, post-exclusive competitive environment
• Revenue trajectory: generally declining to flat after generic uptake, with ongoing net price pressure
• Margin profile: lower gross margin due to heightened rebate and channel pressure; operating margin depends on cost structure and any remaining exclusivity or contract strength
• Primary risk: further erosion if additional generic entrants expand or if payers tighten ICS monotherapy preferencing

Best-fit business interpretation

• Armonair RespiClick likely operates as a “protect-and-defend” brand with diminishing upside rather than a platform for growth. For investors, licensing counterparties, or legal parties, the key commercial facts are driven by formulary position, not by new clinical differentiation.

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Key Takeaways

• Armonair RespiClick is an older flunisolide ICS in a highly substitutable asthma maintenance category.
• Market dynamics are dominated by generic substitution, payer-driven net price compression, and step-therapy to ICS/LABA.
• The financial trajectory in this segment typically shows post-entry share loss followed by stabilization at a residual niche base.
• Patent and litigation events, while critical, require Orange Book and docket-level verification for exact dates and entry outcomes.

FAQs

1. How do PBM rebates usually impact net revenue for legacy inhaled corticosteroid brands like Armonair RespiClick after generic entry?
2. What is the typical order of magnitude revenue decline for an inhaled steroid brand when multiple generic versions launch?
3. Do asthma step-therapy guidelines materially reduce demand for ICS monotherapy products over time?
4. How do device differences between RespiClick and generic inhaler platforms affect patient retention?
5. What Orange Book features (patent scope, expirations, listed exclusivity) most influence Paragraph IV timing for flunisolide inhalation products?

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ (Access required for record-level Armonair RespiClick listings.)