FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE Drug Patent Profile

Which patents cover Fluticasone Propionate And Salmeterol Xinafoate, and when can generic versions of Fluticasone Propionate And Salmeterol Xinafoate launch?

Fluticasone Propionate And Salmeterol Xinafoate is a drug marketed by Hikma and Teva Pharms Usa and is included in two NDAs.

The generic ingredient in FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 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 Fluticasone Propionate And Salmeterol Xinafoate

A generic version of FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	43
Patent Applications:	63
DailyMed Link:	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE at DailyMed

Recent Clinical Trials for FLUTICASONE PROPIONATE AND 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 AND SALMETEROL XINAFOATE clinical trials

Pharmacology for FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

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

US Patents and Regulatory Information for FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	203433-001	Dec 17, 2020	AB	RX	No	No
Teva Pharms Usa	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	213948-001	Dec 13, 2021	AB	RX	No	No
Hikma	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	203433-002	Dec 17, 2020	AB	RX	No	No
Hikma	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	203433-003	Dec 19, 2023	AB	RX	No	No
Teva Pharms Usa	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	213948-003	Dec 13, 2021	AB	RX	No	No
Teva Pharms Usa	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	213948-002	Dec 13, 2021	AB	RX	No	No

EU/EMA Drug Approvals for FLUTICASONE PROPIONATE AND 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

FLUTICASONE PROPIONATE AND 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, commonly known by the brand name Advair, is a combination inhaler used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics and financial trajectory of this crucial medication, highlighting key factors influencing its market value and growth.

Market Size and Growth

The US asthma treatment market, where fluticasone propionate and salmeterol xinafoate is a significant player, was valued at $11.7 billion in 2013 and was estimated to reach $14 billion by 2020, growing at a Compound Annual Growth Rate (CAGR) of 2.6%[1].

Global Market Perspective

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

Key Market Drivers

Several factors drive the growth of the fluticasone propionate and salmeterol xinafoate market:

• Increasing Incidence of Respiratory Problems: The rising prevalence of asthma and COPD globally contributes significantly to the demand for these medications[3].
• Technological Advancements: Improvements in inhaler technology and the development of more effective formulations continue to attract patients and healthcare providers[3].

Patent Expirations and Generic Erosion

The market for fluticasone propionate and salmeterol xinafoate has been impacted by patent expirations. The patent for Advair Diskus expired, leading to the approval of generic versions. For instance, Mylan obtained FDA approval to market a generic version of Advair Diskus in 2019[4].

• Impact on Sales: The introduction of generic versions has led to significant declines in sales revenue for the branded product. However, regulatory hurdles and the complexity of producing bioequivalent ICS/LABA combination drugs have somewhat mitigated the immediate impact of generic erosion[1].

Cost-Effectiveness

Studies have shown that fluticasone propionate and salmeterol xinafoate combination inhalers are cost-effective compared to other treatment options:

• Asthma Treatment: In chronic asthma, switching to fluticasone propionate and salmeterol xinafoate (SFC) is cost-effective compared to increasing the dose of inhaled corticosteroids (ICS) or using separate ICS and LABA inhalers[2].
• COPD Treatment: For COPD, treatment with fluticasone propionate/salmeterol 500/50 microg is cost-effective, with a lifetime incremental cost-effectiveness ratio (ICER) of $33,865/QALY, which is below the commonly accepted threshold of $50,000/QALY[5].

Market Segmentation

The market for fluticasone propionate inhalers, including combinations with salmeterol, is segmented based on:

• Type: Different metered spray options such as 60, 120, and 150 metered sprays[3].
• Application: The market is segmented into pediatric and adult patient groups[3].

Regulatory Environment

The approval of generic versions of fluticasone propionate and salmeterol xinafoate has been facilitated by regulatory bodies. The FDA's approval of Mylan's generic Advair Diskus in 2019 marked a significant milestone in this regard[4].

Competitive Landscape

The market for asthma and COPD treatments is highly competitive, with several branded and generic options available. The entry of generic versions of fluticasone propionate and salmeterol xinafoate has increased competition, driving prices down and affecting the market share of branded products[1].

Future Outlook

Despite the challenges posed by generic erosion, the market for fluticasone propionate and salmeterol xinafoate is expected to remain robust due to:

• Uptake of New Pipeline Drugs: Recently approved and pipeline drugs are expected to offset the impact of patent expirations and generic competition[1].
• Growing Demand: The increasing incidence of respiratory diseases will continue to drive demand for effective treatments like fluticasone propionate and salmeterol xinafoate[3].

Key Takeaways

• The US asthma treatment market, including fluticasone propionate and salmeterol xinafoate, is projected to grow despite patent expirations.
• The global fluticasone propionate inhalers market is expected to reach $8.1 billion by 2032.
• Cost-effectiveness studies support the use of fluticasone propionate and salmeterol xinafoate over other treatment options.
• Market segmentation is based on type and application, with different metered spray options and patient groups.
• Regulatory approvals for generic versions have increased competition but also expanded access to affordable treatments.

FAQs

What is the expected growth rate of the fluticasone propionate inhalers market by 2032?

The fluticasone propionate inhalers market is expected to exhibit a CAGR of 4.6% by 2032[3].

How has the patent expiration of Advair Diskus affected the market?

The patent expiration of Advair Diskus has led to the approval of generic versions, resulting in significant declines in sales revenue for the branded product but also increasing competition and reducing prices[1][4].

Is fluticasone propionate and salmeterol xinafoate cost-effective for COPD treatment?

Yes, treatment with fluticasone propionate/salmeterol 500/50 microg is cost-effective for COPD, with an ICER of $33,865/QALY, which is below the commonly accepted threshold of $50,000/QALY[5].

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

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

How is the market for fluticasone propionate inhalers segmented?

The market is segmented based on type (different metered spray options) and application (pediatric and adult patient groups)[3].

Sources

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