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, Teva Pharms Usa, and Mylan, and is included in six NDAs. There are twenty-eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Twelve suppliers are listed for this compound.

Summary for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

International Patents:	487
US Patents:	28
Tradenames:	8
Applicants:	5
NDAs:	6
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
European Research Council	Phase 4
Imperial College London	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
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	11,464,923		Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	No	9,216,260*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	9,216,260*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No	9,616,024*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No	10,195,375*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No	11,464,923		Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No	10,918,816*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 DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019	8,006,690
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006	6,997,349*PED
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	7,389,775*PED
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017	6,748,947
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	7,389,775*PED
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006	6,546,928*PED
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006	7,143,908*PED

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/004267 Airexar 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
European Patent Office	3701988	MODULE D'AIDE À LA CONFORMITÉ POUR UN INHALATEUR (COMPLIANCE-ASSISTING MODULE FOR AN INHALER)
European Patent Office	2987523	COMPTEURS DE DOSES POUR INHALATEURS (DOSE COUNTERS FOR INHALERS)
Poland	1699434
World Intellectual Property Organization (WIPO)	2018130723
Israel	223116
Eurasian Patent Organization	201790479	МОДУЛЬ КОНТРОЛЯ СОБЛЮДЕНИЯ РЕЖИМА ДЛЯ АКТИВИРУЕМОГО ВДОХОМ ИНГАЛЯТОРА
World Intellectual Property Organization (WIPO)	2016118589

Supplementary Protection Certificates for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
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
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	2018C/022	Belgium		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: 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

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluticasone Propionate and Salmeterol Xinafoate

Introduction

Fluticasone propionate and salmeterol xinafoate are key components in the treatment of asthma and chronic obstructive pulmonary disease (COPD). These medications, often combined in inhalers like Advair and Seretide, have been pivotal in managing respiratory conditions. Here, we delve into the market dynamics and financial trajectory of these drugs.

Market Size and Growth

The market for asthma and COPD treatments, which include fluticasone propionate and salmeterol xinafoate, has been growing steadily. The US asthma treatment market, for instance, was valued at $11.7 billion in 2013 and was estimated to reach $14 billion by 2020, with a Compound Annual Growth Rate (CAGR) of 2.6%[1].

On a global scale, the fluticasone propionate inhalers market was valued at approximately $5.6 billion in 2023 and is expected to reach $8.1 billion by 2032, exhibiting a CAGR of 4.6%[3].

Key Drivers of Market Growth

Several factors drive the growth of this market:

Increasing Incidence of Respiratory Problems

The rising incidence of respiratory diseases such as asthma and COPD is a significant driver. As the global population ages and urbanization increases, the prevalence of these conditions is expected to rise, thereby increasing demand for effective treatments[3].

Technological Advancements

Advancements in inhaler technology and the development of new formulations and delivery systems are also driving market growth. These innovations improve the efficacy and convenience of treatments, making them more appealing to patients and healthcare providers[3].

Regulatory Approvals

Regulatory approvals for generic versions of these drugs have also impacted the market. For example, the FDA approved the first generic version of Advair Diskus in 2019, which has expanded access to these medications and influenced market dynamics[4].

Impact of Patent Expirations

Patent expirations have significantly affected the market for fluticasone propionate and salmeterol xinafoate. The expiration of patents for branded drugs like Singulair, Advair, and Symbicort has led to the entry of generic competitors. For instance, Singulair’s patent expired in 2012, resulting in substantial generic erosion and a decline in sales revenue for the branded version[1].

However, the transition to generic versions of ICS/LABA combination drugs like Advair has been slower due to regulatory hurdles and the complexity of producing bioequivalent inhaler devices. This has allowed some branded products to maintain market share despite patent expirations[1].

Cost-Effectiveness and Economic Impact

The cost-effectiveness of fluticasone propionate and salmeterol xinafoate combination inhalers has been a subject of extensive study.

Cost-Effectiveness in Asthma Treatment

Studies have shown that using salmeterol xinafoate/fluticasone propionate combination inhalers (SFC) is cost-effective compared to other inhaled corticosteroid (ICS) regimens. For adults and children uncontrolled on other ICS doses, switching to SFC can be a cost-effective approach, offering both clinical efficacy and cost savings[2].

Cost-Effectiveness in COPD Treatment

In the treatment of COPD, fluticasone propionate/salmeterol combination therapy has been found to be cost-effective compared to no maintenance treatment. The lifetime incremental cost-effectiveness ratio (ICER) for this combination is estimated to be around $33,865/QALY, which is below the commonly accepted threshold of $50,000/QALY[5].

Pipeline and Future Developments

The future of the market is also influenced by the pipeline of new and innovative treatments. The approval of new drugs and the development of phenotype-targeted treatments, such as IL-targeting monoclonal antibodies, are expected to drive market growth. These novel therapies offer the potential for personalized treatment, which could significantly improve patient outcomes and market dynamics[1].

Market Segmentation

The market for fluticasone propionate inhalers is segmented based on type (e.g., 60 metered sprays, 120 metered sprays, 150 metered sprays) and application (e.g., kids, adults). Understanding these segments is crucial for manufacturers and marketers to tailor their products and strategies to specific patient needs[3].

Competitive Landscape

The competitive landscape for fluticasone propionate and salmeterol xinafoate is dynamic, with both branded and generic players vying for market share. The entry of generic versions of Advair and other branded inhalers has increased competition, but the complexity of producing bioequivalent ICS/LABA combination drugs has maintained some level of market differentiation for branded products[1][4].

Regulatory Environment

The regulatory environment plays a critical role in shaping the market. Approvals for generic versions and new formulations are closely monitored by regulatory bodies like the FDA. These approvals can significantly impact market dynamics and the financial trajectory of these drugs[4].

Patient Impact and Quality of Life

The use of fluticasone propionate and salmeterol xinafoate has a significant impact on patient quality of life. These medications help control symptoms, reduce exacerbations, and improve overall health outcomes. The cost-effectiveness and availability of these treatments are crucial for ensuring that patients receive the best possible care[2][5].

Key Takeaways

• The market for fluticasone propionate and salmeterol xinafoate is driven by increasing incidence of respiratory diseases and technological advancements.
• Patent expirations have led to the entry of generic competitors, but regulatory hurdles have slowed the transition for ICS/LABA combination drugs.
• These medications are cost-effective in both asthma and COPD treatment, offering significant clinical and economic benefits.
• The pipeline of new treatments, including phenotype-targeted therapies, is expected to further drive market growth.
• Market segmentation and the competitive landscape are critical factors influencing the financial trajectory of these drugs.

FAQs

What is the projected market size for fluticasone propionate inhalers by 2032?

The fluticasone propionate inhalers market is expected to reach USD 8.1 billion by 2032[3].

How have patent expirations affected the market for fluticasone propionate and salmeterol xinafoate?

Patent expirations have led to generic erosion, particularly for Singulair, but the transition for ICS/LABA combination drugs like Advair has been slower due to regulatory hurdles[1].

Are fluticasone propionate and salmeterol xinafoate combination inhalers cost-effective?

Yes, these combination inhalers have been shown to be cost-effective in both asthma and COPD treatment, offering better clinical outcomes and cost savings compared to other regimens[2][5].

What are the key drivers of the fluticasone propionate inhalers market?

The key drivers include the increasing incidence of respiratory problems and technological developments and advancements in inhaler technology[3].

How do regulatory approvals impact the market for these drugs?

Regulatory approvals, such as the FDA approval for generic versions of Advair, can significantly expand access to these medications and influence market dynamics[4].

Sources

1. GBI Research: "US Asthma Treatment Market Value to Hit $14 Billion"[1]
2. PubMed: "Cost-effectiveness of salmeterol xinafoate/fluticasone propionate combination inhaler (SFC) (Seretide) compared with other inhaled corticosteroid (ICS) containing regimens"[2]
3. Business Research Insights: "Fluticasone Propionate Inhalers Market Size, Share & Report, 2032"[3]
4. FDA: "FDA approves first generic Advair Diskus"[4]
5. PubMed: "Cost-effectiveness of fluticasone propionate/salmeterol (500/50 microg) compared with no maintenance treatment in COPD"[5]