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, Hikma, Respirent Pharms, Teva Pharms Usa, and Mylan, and is included in seven NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate; salmeterol xinafoate has two hundred and thirty-seven patent family members in thirty-five countries.

Twelve suppliers are listed for this compound.

Summary for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

International Patents:	237
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
Mylan	WIXELA INHUB	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208891-002	Jan 30, 2019	AB	RX	No	No
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		DISCN	Yes	No					Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No					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					Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No					Y
Hikma	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	203433-001	Dec 17, 2020	AB	RX	No	No

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	208799-001	Jan 27, 2017
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006

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
Israel	241912
Mexico	2017009122	INHALADOR DE POLVO SECO CON PROPIONATO DE FLUTICASONA Y XINAFOATO DE SALMETEROL. (DRY POWDER INHALER COMPRISING FLUTICASONE PROPIONATE AND SALMETEROL XINAFOAT.)
South Africa	201701045
South Korea	102364945
Eurasian Patent Organization	035271
European Patent Office	3097937
New Zealand	599658

Supplementary Protection Certificates for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844	18C1022	France		PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
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
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	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
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

Fluticasone Propionate/Salmeterol Xinafoate: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

This analysis examines the market dynamics and financial trajectory for the fixed-dose combination drug containing fluticasone propionate and salmeterol xinafoate, primarily used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The report details patent exclusivity, market share, key competitors, and projected revenue streams.

What is the Patent Landscape for Fluticasone Propionate/Salmeterol Xinafoate?

The patent landscape for the combination of fluticasone propionate and salmeterol xinafoate is characterized by the expiration of original composition of matter patents, leading to the emergence of generic competition. Key patents covering the original drug product, marketed by GlaxoSmithKline (GSK) as Advair Diskus/Seretide, have expired.

• Original Exclusivity: The initial patents for the combination and specific formulations have long expired. For example, the U.S. Patent No. 5,693,616, covering fluticasone propionate, expired in 2014. Patents related to salmeterol xinafoate also expired prior to this. [1]
• Formulation Patents: While core ingredient patents have expired, secondary patents related to specific device technology (e.g., the Diskus inhaler), manufacturing processes, or new therapeutic uses can extend market exclusivity for branded products. These secondary patents have also largely expired or face significant challenges from generic manufacturers.
• Generic Entry: The expiration of these patents has facilitated the entry of numerous generic versions of fluticasone propionate/salmeterol xinafoate inhalation powder and spray. This has significantly impacted pricing and market share for the originator product.
• ANDA Filings: The U.S. Food and Drug Administration (FDA) has approved Abbreviated New Drug Applications (ANDAs) for multiple generic versions of the combination drug. For instance, Mylan N.V. (now Viatris) received FDA approval for its generic Advair Diskus in 2019. [2]

Who are the Key Market Players and Competitors?

The market for fluticasone propionate/salmeterol xinafoate is highly competitive, with a significant shift from a branded monopoly to a generic-dominated landscape.

• Originator: GlaxoSmithKline (GSK) was the primary originator of the combination under the brand names Advair and Seretide. While still a significant player, its market share has been eroded by generic competition.
• Generic Manufacturers: A substantial number of pharmaceutical companies now manufacture and market generic versions of fluticasone propionate/salmeterol xinafoate. Prominent players include:
  • Teva Pharmaceutical Industries Ltd.
  • Viatris Inc. (formed by the merger of Mylan and Upjohn)
  • Aurobindo Pharma Ltd.
  • Dr. Reddy's Laboratories Ltd.
  • Sun Pharmaceutical Industries Ltd.
  • Hikma Pharmaceuticals PLC
• Market Share Shift: Post-patent expiration, generic manufacturers have captured a substantial portion of the market. The total market value has also seen a decline due to price erosion inherent in generic competition.
• Competition Drivers: Competition is driven by price, product availability, and therapeutic equivalence. The ease of biosimilar development for small molecule drugs, unlike biologics, has accelerated generic market penetration.

What is the Current Market Size and Growth Trajectory?

The global market for fluticasone propionate/salmeterol xinafoate has experienced a significant contraction in revenue for the originator product due to generic competition. However, the overall volume of the drug dispensed remains high due to its efficacy in treating prevalent respiratory conditions.

• Market Value Decline: The U.S. market for Advair Diskus, for example, saw a sharp decline in sales from billions of dollars annually to a fraction of that following generic launches. In 2019, GSK reported Advair sales of approximately $3.7 billion globally, with a significant portion of this decline attributed to U.S. genericization. [3]
• Volume Stability: Despite revenue declines for branded products, the demand for the therapeutic class remains robust. Asthma affects an estimated 300 million people globally, and COPD affects over 200 million. [4] This sustained demand ensures a significant volume of generic fluticasone propionate/salmeterol xinafoate is prescribed.
• Growth in Generic Segment: While the branded segment has contracted, the generic segment has experienced substantial growth in terms of revenue and volume. This growth is directly attributable to market penetration by multiple generic manufacturers.
• Global Distribution: The drug is widely prescribed across North America, Europe, and Asia-Pacific. Emerging markets represent potential areas for volume growth as healthcare access expands.
• Projected Trends: The market is expected to remain highly competitive. Pricing pressures will continue, and growth will primarily be driven by volume increases in generic formulations and wider adoption in markets with expanding healthcare infrastructure. Specialized inhalation devices may offer niche differentiation for some manufacturers.

What are the Financial Implications and Revenue Projections?

The financial implications for fluticasone propionate/salmeterol xinafoate are bifurcated: a significant decline in revenue for the originator and sustained, albeit lower-margin, revenue for generic manufacturers.

• Originator Revenue Erosion: GSK's revenue from Advair/Seretide has dramatically decreased. Global sales for Advair fell from over $4 billion in FY2016 to approximately $1.7 billion in FY2021. [5] This decline is a direct consequence of the loss of market exclusivity and subsequent generic competition.
• Generic Manufacturer Revenue: Individual generic manufacturers generate revenue through sales of their respective formulations. While precise global revenue figures for all generic fluticasone propionate/salmeterol xinafoate products are difficult to aggregate, the collective market value for generic respiratory inhalers is substantial, likely in the high hundreds of millions or low billions of dollars annually in the U.S. alone.
• Profit Margins: Generic manufacturers typically operate on lower profit margins compared to originators during their exclusivity period. However, the high volume of prescriptions for these widely used medications allows for significant aggregate revenue.
• Pricing Dynamics: The average selling price (ASP) of fluticasone propionate/salmeterol xinafoate has fallen by as much as 70-80% in the U.S. following generic launches compared to the branded Advair Diskus. [6] This price erosion is a fundamental characteristic of the generic pharmaceutical market.
• Future Revenue Streams:
  • Originator: Future revenue for GSK from this product class will likely be minimal, primarily relying on international markets where patent expirations may be staggered or on niche formulations.
  • Generic Manufacturers: Continued revenue generation is expected for generic producers. Growth will be linked to market share capture, expansion into new geographical regions, and potential development of improved generic delivery devices. The market is projected to stabilize with intense competition driving incremental gains.

What is the Impact of Therapeutic Equivalency and Regulatory Approvals?

Therapeutic equivalency and regulatory approvals are foundational to the market dynamics of fluticasone propionate/salmeterol xinafoate, particularly in the transition from branded to generic dominance.

• FDA Approval Process: The FDA's approval of ANDAs signifies that a generic drug is bioequivalent to the reference listed drug (RLD), meaning it has the same active ingredient, dosage form, strength, and route of administration. This ensures that generics are safe and effective for their intended uses. [7]
• Bioequivalence Studies: Generic manufacturers must conduct rigorous bioequivalence studies to demonstrate that their product performs comparably to the branded drug in the body. These studies are critical for regulatory approval.
• Therapeutic Equivalence: Once approved, generic fluticasone propionate/salmeterol xinafoate products are considered therapeutically equivalent to Advair. This allows physicians to prescribe generics with confidence and payers to cover them. The FDA's Orange Book lists therapeutic equivalence codes for approved drugs. [8]
• Market Acceptance: Physician and patient acceptance of generic versions is crucial for market penetration. Extensive clinical use of the branded product and established efficacy of the active ingredients contribute to the widespread adoption of generics.
• Competition Enablement: Regulatory approvals directly enable competition. The availability of multiple approved generic versions intensifies market competition, leading to price reductions and increased patient access.
• Global Regulatory Approvals: Similar regulatory pathways exist in other major markets, such as the European Medicines Agency (EMA) in Europe. Approval by these agencies facilitates global market entry for generic manufacturers.

What are the Key Takeaways?

The market for fluticasone propionate/salmeterol xinafoate is characterized by the successful transition from a branded monopoly to a highly competitive generic landscape. Patent expirations have led to significant price erosion for the originator product, Advair/Seretide, while enabling multiple generic manufacturers to capture market share. The sustained prevalence of asthma and COPD ensures continued high-volume demand for these treatments, supporting revenue generation for generic players. Therapeutic equivalency and robust regulatory approval processes by agencies like the FDA are critical enablers of this competitive market structure. Future market dynamics will be driven by ongoing price competition, global market expansion for generics, and potential innovations in drug delivery devices.

Frequently Asked Questions

1. When did the primary patents for fluticasone propionate/salmeterol xinafoate expire in major markets like the U.S.? The core composition of matter patents expired years ago. For instance, patents covering fluticasone propionate expired around 2014, and those for salmeterol xinafoate also expired prior to that, allowing for generic entry.

2. What is the typical price reduction observed for generic fluticasone propionate/salmeterol xinafoate compared to the branded Advair Diskus in the U.S.? Price reductions can range from 70% to 80% or more following the introduction of generic alternatives, reflecting typical generic market dynamics.

3. Beyond price, what factors influence competition among generic fluticasone propionate/salmeterol xinafoate manufacturers? Competition also centers on supply chain reliability, market access with payers, and the availability of different dosage forms or device variations, though the latter is less common for older generics.

4. Are there any new therapeutic uses or formulations of fluticasone propionate/salmeterol xinafoate that are still under patent protection? While original patents have expired, specific delivery devices or novel combination ratios might be subject to secondary patents. However, these typically offer limited exclusivity periods compared to initial composition of matter patents.

5. How does the volume of fluticasone propionate/salmeterol xinafoate prescribed compare to its current market revenue for the originator product? Prescription volumes remain high due to the prevalence of respiratory diseases, but the market revenue for the originator has drastically decreased due to price competition from generics.

Citations

[1] U.S. Patent 5,693,616. (1997). Inhaler device. Google Patents. Retrieved from https://patents.google.com/patent/US5693616A/en (Note: This patent covers a dry powder inhaler device, relevant to the delivery of fluticasone propionate. Original composition of matter patents would have expired earlier).

[2] U.S. Food and Drug Administration. (2019, February 26). FDA approves first generic version of Advair Diskus. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/news-events-consumer-health/fda-approves-first-generic-version-advair-diskus

[3] GlaxoSmithKline. (2020). Annual Report and Accounts 2019. Retrieved from https://www.gsk.com/media/6049/annual-report-and-accounts-2019.pdf (Note: Specific sales figures for Advair are within the report, typically in the financial review section for respiratory products).

[4] World Health Organization. (2023, May 4). Chronic obstructive pulmonary disease (COPD). World Health Organization. Retrieved from https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd) and World Health Organization. (2022, May 3). Asthma. World Health Organization. Retrieved from https://www.who.int/news-room/fact-sheets/detail/asthma

[5] GlaxoSmithKline. (2022). Annual Report and Accounts 2021. Retrieved from https://www.gsk.com/media/7024/gsk-annual-report-and-accounts-2021.pdf (Note: Sales data for specific brands like Advair are typically detailed within the financial performance sections).

[6] Pharmaceutical Executive. (2019, March 21). Advair Generic Enters U.S. Market. Pharmaceutical Executive. Retrieved from https://www.pharmaceuticalexecutive.com/view/advair-generic-enters-us-market (Note: This article discusses price erosion by generic entrants).

[7] U.S. Food and Drug Administration. (2020, May 20). ANDAs: Abbreviations for Drug Applications. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/abbreviated-new-drug-applications-andas-generics/andas-abbreviations-drug-applications

[8] U.S. Food and Drug Administration. (2021, July 22). Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book). U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-ratings-generics/approved-drug-products-therapeutic-equivalence-evaluations-orange-book