FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - Generic Drug Details

What are the generic drug sources for fluticasone propionate; salmeterol xinafoate and what is the scope of patent protection?

Fluticasone propionate; salmeterol xinafoate is the generic ingredient in eight branded drugs marketed by Glaxo Grp Ltd, Teva Pharm, Cipla, Hikma, Respirent Pharms, Teva Pharms Usa, and Mylan, and is included in eight NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

International Patents:	239
US Patents:	7
Tradenames:	8
Applicants:	6
NDAs:	7
Finished Product Suppliers / Packagers:	12
Clinical Trials:	43
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
DailyMed Link:	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE at DailyMed

Recent Clinical Trials for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novartis Pharmaceuticals	Phase 3
Imperial College London	Phase 4
European Research Council	Phase 4

See all FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE clinical trials

Pharmacology for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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

Anatomical Therapeutic Chemical (ATC) Classes for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipla	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	213087-001	Jul 27, 2026	AB	RX	No	No
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	9,066,957*PED				Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	Yes	10,195,375*PED				Y
Respirent Pharms	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	214464-002	Jan 12, 2026	AB	RX	No	No
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes	9,066,957*PED				Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes	10,195,375*PED				Y

Expired US Patents for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017	6,748,947
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019	6,748,947
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019	6,748,947
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017	6,701,917
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017	6,718,972
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017	6,748,947

EU/EMA Drug Approvals for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Country	Patent Number	Title	Estimated Expiration
Australia	2010314369
Australia	2014201778
Australia	2017204342
Brazil	112012010354
Canada	2779347
Chile	2012001158

Supplementary Protection Certificates for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
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	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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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

Fluticasone Propionate and Salmeterol Xinafoate: Market Dynamics, Patent Expiry and Financial Trajectory

Last updated: September 8, 2026

Fluticasone propionate/salmeterol xinafoate is a mature inhaled corticosteroid/long-acting beta agonist combination commercialized primarily as Advair Diskus and Seretide. The product has lost core U.S. exclusivity, and FDA-approved generic competition is established through Wixela Inhub. Revenue has shifted from a branded growth product to a cash-generating legacy franchise exposed to generic substitution, contracting pressure and newer triple-therapy products such as Trelegy Ellipta.

The product remains commercially relevant because of its large installed patient base, physician familiarity and broad asthma and chronic obstructive pulmonary disease use. Its financial trajectory is structurally negative in branded markets, although manufacturing scale, global sales and residual device barriers continue to support meaningful cash flow.

What drugs contain fluticasone propionate and salmeterol xinafoate?

The active ingredients are fluticasone propionate, an inhaled corticosteroid, and salmeterol xinafoate, a long-acting beta-2 adrenergic agonist. The combination is approved for maintenance treatment of asthma and airflow obstruction in chronic obstructive pulmonary disease.

Product	Company or commercial originator	Device	Main markets	Regulatory position
Advair Diskus	GSK	Dry-powder inhaler	United States and selected markets	Reference product; generic competition
Advair HFA	GSK	Metered-dose inhaler	United States	Branded product; distinct device and formulation
Seretide Accuhaler	GSK	Dry-powder inhaler	Europe and international markets	Regional brand equivalent
Seretide Evohaler	GSK	Metered-dose inhaler	Europe and international markets	Regional HFA product
Wixela Inhub	Viatris	Dry-powder inhaler	United States	FDA-approved substitutable generic to Advair Diskus
AirDuo RespiClick	Teva	Breath-actuated dry-powder inhaler	United States	Separate branded-generic product; not automatically substitutable for Advair Diskus

Advair Diskus is marketed in 100/50, 250/50 and 500/50 microgram strengths, expressed as fluticasone propionate/salmeterol. Advair HFA is marketed in 45/21, 115/21 and 230/21 microgram strengths per actuation. The different delivery systems are clinically related but not interchangeable for regulatory substitution purposes.

When did fluticasone propionate/salmeterol lose exclusivity?

Core exclusivity has expired. Advair Diskus was approved by the FDA in 2000, and its principal active-ingredient and product patents are no longer the primary barrier to generic entry. Pediatric exclusivity and other early regulatory protections also expired years ago.

The more important question is whether a competitor can reproduce the full product, including the inhaler, powder properties, dose-delivery performance and equivalence profile. Dry-powder inhalers can impose more development complexity than conventional oral solid products because the FDA evaluates device performance and in-vitro and clinical comparability.

U.S. exclusivity timeline

Event	Date or period	Commercial effect
Advair Diskus FDA approval	2000	Established the U.S. reference product
Advair HFA FDA approval	2006	Expanded the product into a metered-dose platform
Pediatric and early regulatory protections	Expired	Removed regulatory exclusivity
Teva AirDuo RespiClick approval	2017	Added a lower-cost, non-substitutable alternative
First FDA-approved generic Diskus equivalent	December 2018	Opened direct generic competition
Wixela Inhub commercial launch	2019	Created pharmacy-level substitution pressure
Current U.S. status	Mature generic market	Branded price and volume erosion

The exact patent landscape differs by product, strength, device and jurisdiction. Orange Book listings for Advair-related products historically included patents directed to formulation, inhaler construction and product characteristics rather than only the active ingredients. Those listings no longer prevent U.S. generic access to the Diskus reference product. The FDA Orange Book remains the controlling source for listed U.S. patents and exclusivity codes.[1]

What patents protect fluticasone propionate and salmeterol products?

The patent estate historically covered four technical categories:

1. The combination of fluticasone propionate and salmeterol.
2. Dry-powder formulations containing the active ingredients and lactose carrier.
3. Inhaler architecture, including blister strips, dose indexing and powder dispersion.
4. Manufacturing and filling methods for inhalation-dose units.

The active compounds themselves are long-established and no longer provide meaningful composition-of-matter protection. Remaining value has been concentrated in delivery technology, formulation performance and manufacturing know-how.

How strong is the patent estate?

The estate is weak as a barrier to generic Diskus entry but remains relevant in three areas:

• Device replication: A competitor must meet dose-delivery and usability requirements without necessarily copying every protected structural element.
• Formulation equivalence: Particle size, carrier interaction, moisture control and emitted-dose consistency affect regulatory approval.
• International enforcement: Patent expiry dates and national validity outcomes differ across Europe, Asia-Pacific and emerging markets.

The estate is stronger against a technically differentiated inhaler than against a conventional generic formulation. It is weaker where a rival uses an alternative device, obtains approval through a product-specific pathway or relies on independent engineering rather than literal copying.

No single patent is likely to restore Advair’s former monopoly economics. The commercial question is the cumulative cost of development, manufacturing validation, regulatory studies and market access.

What is the Orange Book status of Advair and Wixela?

Advair Diskus is the U.S. reference product for fluticasone propionate/salmeterol inhalation powder. Wixela Inhub was approved through an abbreviated new drug application and is substitutable at the pharmacy level in the strengths approved by the FDA.

Teva’s AirDuo RespiClick is a separate product. Although it contains the same active ingredients, its device and regulatory pathway mean it is not simply an interchangeable generic version of Advair Diskus. This distinction is commercially important because substitution depends on FDA therapeutic-equivalence ratings, not only on active-ingredient identity.

The U.S. regulatory structure is therefore segmented:

Product category	FDA pathway	Substitution position
Advair Diskus	New drug application	Reference product
Wixela Inhub	Abbreviated new drug application	Generic substitution to Advair Diskus
AirDuo RespiClick	New drug application	Separate product; no automatic Diskus substitution
Advair HFA	New drug application	Different metered-dose platform

Which companies challenged Advair patents?

The principal competitive challenge came from generic manufacturers seeking approval for fluticasone propionate/salmeterol inhalation powder. Viatris, through the Mylan organization, obtained approval for Wixela Inhub. Teva developed AirDuo RespiClick and related products using a different device platform.

Historical patent disputes involving Advair and its inhaler technology included Abbreviated New Drug Application Paragraph IV challenges, patent-validity disputes and litigation over whether generic products infringed listed formulation or device claims. These disputes were commercially significant before generic approval, but the market has moved beyond the period when litigation could preserve the original Advair franchise.

What was the role of Paragraph IV challenges?

A Paragraph IV certification allows an ANDA applicant to assert that a listed patent is invalid, unenforceable or not infringed. Such a filing can trigger litigation and a potential 30-month stay of FDA approval under the Hatch-Waxman framework.

For Advair, Paragraph IV activity focused on generic versions of the inhalation powder product. The practical outcome was delayed but not prevented generic entry. Once the first generic reached the market, the value of later litigation declined because price competition and contracting became the dominant commercial factors.

What patent litigation affects fluticasone propionate/salmeterol?

Current commercial risk is primarily post-expiry litigation risk rather than launch-blocking risk. Potential disputes can still involve:

• Device patent infringement.
• Manufacturing-process claims.
• Trade secrets relating to powder blending or filling.
• False-marketing or product-label disputes.
• State substitution and pharmacy-channel issues.
• Contracting arrangements with wholesalers, payers and group purchasing organizations.

Settlement agreements in inhaled products can include delayed launch dates, limited licenses, authorized-generic arrangements or restrictions on device use. The economic value of a settlement depends on the number of generic entrants and whether the agreement preserves a meaningful period before multi-source competition.

There is no biosimilar litigation pathway for this product. Fluticasone propionate/salmeterol is a small-molecule combination drug, and competitors use ANDA, NDA or local generic pathways rather than the U.S. biosimilar framework under the Public Health Service Act.

How has the financial trajectory changed?

Advair was one of GSK’s most important respiratory products for more than a decade. Its financial profile changed in three stages:

Stage 1: Branded growth and franchise expansion

Before generic competition, Advair benefited from:

• Large asthma and COPD patient populations.
• High brand recognition.
• Broad physician adoption.
• A limited number of direct fixed-dose competitors.
• Reimbursement support in major markets.

GSK’s respiratory portfolio generated multibillion-pound revenue during the period when Advair and Seretide were central products. Annual reports show a sustained decline in Advair/Seretide revenue as patents expired, payer pressure increased and patients moved to alternative inhalers.[2][3]

Stage 2: Patent expiry and managed decline

The U.S. market began to experience stronger generic pressure after the FDA approved Wixela Inhub. Pharmacy substitution reduced the ability of Advair Diskus to maintain historical net pricing. GSK also faced price concessions from managed-care organizations seeking to control inhaled respiratory spending.

The erosion pattern was more severe for price than for patient volume. A large portion of the installed base remained on fluticasone propionate/salmeterol, but the economic value shifted from the originator to lower-priced suppliers and payers.

Stage 3: Portfolio replacement

GSK redirected respiratory investment toward products with longer commercial lives and greater clinical differentiation, especially:

• Trelegy Ellipta, a once-daily inhaled triple therapy.
• Breo Ellipta, a fluticasone furoate/vilanterol combination.
• Nucala, an anti-interleukin-5 biologic for severe eosinophilic asthma.
• Other specialty respiratory and immunology products.

Trelegy is strategically more important than Advair because it adds a long-acting muscarinic antagonist to the inhaled corticosteroid/LABA combination and targets patients requiring triple therapy. This product migration helps GSK retain respiratory revenue even as Advair declines.

How much revenue exposure remains?

GSK has reduced the prominence of Advair as a separately reported growth driver. Public disclosures increasingly emphasize broader respiratory categories and newer products rather than a standalone Advair revenue line. The relevant exposure is now divided among:

Exposure area	Direction
Advair Diskus branded U.S. sales	Declining
Advair HFA sales	Declining, with device-specific barriers
International Seretide sales	Declining at different rates by country
Wixela and other generic products	Growing from a low base
GSK respiratory replacement products	Increasing
Manufacturing contribution	More resilient than branded pricing

For investors, the key metric is not historical Advair peak sales. It is the rate at which generic substitution reduces net sales and gross margin, and whether Trelegy and newer respiratory products replace that loss.

GSK’s economic exposure is moderated by the age of the asset. Development costs have been recovered, manufacturing processes are established and commercial infrastructure is largely in place. The product can remain profitable after patent expiry if manufacturing utilization stays high, although the margin profile is materially lower under multi-source competition.

How does Advair compare with competing respiratory combinations?

Product	Ingredients	Device	Competitive position
Advair/Seretide	Fluticasone propionate/salmeterol	Diskus, HFA and regional equivalents	Mature; generic exposure
Symbicort	Budesonide/formoterol	Turbuhaler or metered-dose inhaler	Large established competitor; generic exposure in some markets
Dulera	Mometasone/formoterol	Metered-dose inhaler	Asthma-focused alternative
Breo Ellipta	Fluticasone furoate/vilanterol	Ellipta	Newer once-daily GSK alternative
Trelegy Ellipta	Fluticasone furoate/umeclidinium/vilanterol	Ellipta	Higher-value triple therapy
AirDuo RespiClick	Fluticasone propionate/salmeterol	RespiClick	Lower-cost alternative using a distinct device
Wixela Inhub	Fluticasone propionate/salmeterol	Inhub	Direct generic Diskus competitor

Advair’s disadvantages are twice-daily dosing, mature patent status and generic substitution. Its advantages are clinical familiarity, broad historical use and extensive physician experience.

What generic entry risks exist?

The main generic-entry scenarios are:

Single-generic market

If only one substitutable generic remains active, price erosion can be gradual. The originator may retain a meaningful share through formulary preference, patient familiarity and contracting.

Multi-generic market

Several approved suppliers can drive rapid price reductions. Wholesaler and payer negotiations then shift toward lowest net cost, supply reliability and rebate economics.

Device-led segmentation

A company may avoid direct substitution by launching a distinct inhaler. This creates competitive pressure without necessarily capturing the entire Advair Diskus prescription base.

Supply-constrained market

Inhaled products are vulnerable to manufacturing interruptions because they require specialized filling, powder handling, device assembly and quality-control testing. Supply shortages can temporarily improve incumbent pricing power, but they do not restore durable exclusivity.

What manufacturing and intellectual-property barriers remain?

The main barriers are operational rather than patent-based. A successful supplier must control:

• Micronized active pharmaceutical ingredients.
• Lactose-carrier blending.
• Moisture and electrostatic behavior.
• Dose uniformity.
• Blister or reservoir filling.
• Device assembly.
• In-vitro equivalence testing.
• Global quality-system compliance.

These requirements can limit the number of reliable suppliers even after patent expiry. They also increase the value of manufacturing know-how and validated supply chains. For licensing or acquisition analysis, manufacturing redundancy may be more important than the remaining patent term.

What is the outlook for fluticasone propionate/salmeterol?

The product is a declining but durable franchise. U.S. branded revenue should continue to contract as generic substitution expands and payers favor lower-cost alternatives. International erosion will vary according to local patent terms, tender systems, reference pricing and availability of authorized or independent generics.

The product remains commercially relevant in three situations:

1. Generic manufacturers seeking a large, established inhaled combination market.
2. Payers seeking lower-cost maintenance therapy.
3. Manufacturers with efficient inhaler platforms and reliable respiratory supply chains.

The strategic value for GSK is defensive rather than growth-oriented. Advair protects patient continuity and manufacturing scale while Trelegy, Breo and specialty products carry the respiratory portfolio forward.

Key Takeaways

• Fluticasone propionate/salmeterol is marketed principally as Advair and Seretide.
• Core U.S. exclusivity has expired.
• Wixela Inhub is the principal FDA-approved substitutable generic to Advair Diskus.
• AirDuo RespiClick competes through a separate device and is not automatically substitutable for Diskus.
• The remaining patent value is concentrated in inhaler design, formulation and manufacturing technology.
• Biosimilar risk does not apply because this is a small-molecule combination product.
• GSK’s Advair revenue has declined as generic substitution and payer pressure increased.
• GSK’s growth strategy has shifted toward Trelegy, Breo and biologic respiratory products.
• Manufacturing capability remains a meaningful barrier after patent expiry.
• The commercial outlook is stable-to-declining for the legacy product and stronger for differentiated or triple-therapy replacements.

FAQs

Is fluticasone propionate/salmeterol still under patent?

Core patents have expired, and generic competition is established in the United States. Device- and formulation-related rights may have differed by product and jurisdiction.

Is Wixela the same as Advair?

Wixela Inhub contains the same active ingredients and is an FDA-approved generic equivalent to Advair Diskus in approved strengths. Its inhaler device is different.

Can pharmacies automatically substitute AirDuo for Advair?

No. AirDuo RespiClick uses a separate device and regulatory pathway. Automatic substitution depends on FDA therapeutic-equivalence status and state pharmacy law.

Does fluticasone propionate/salmeterol have biosimilar competition?

No. Biosimilars apply to biologic products. This combination is regulated through small-molecule drug pathways, including ANDAs and NDAs.

Which product replaced Advair as GSK’s main respiratory growth driver?

Trelegy Ellipta is the principal strategic successor in GSK’s respiratory portfolio because it provides once-daily triple therapy with an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta agonist.

References

1. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: The Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

2. GSK plc. (2019). Annual report 2018. https://www.gsk.com/en-gb/investors/annual-reports/

3. GSK plc. (2024). Annual report 2023. https://www.gsk.com/en-gb/investors/annual-reports/

4. U.S. Food and Drug Administration. (2018, December 21). FDA approves first generic of Advair Diskus to treat asthma and COPD. https://www.fda.gov

5. U.S. Food and Drug Administration. (2017). FDA approves AirDuo RespiClick and ArmonAir RespiClick. https://www.fda.gov

6. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/