ADVAIR DISKUS 100/50 Drug Patent Profile

When do Advair Diskus 100/50 patents expire, and when can generic versions of Advair Diskus 100/50 launch?

Advair Diskus 100/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in ADVAIR DISKUS 100/50 is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Eleven 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 Advair Diskus 100/50

A generic version of ADVAIR DISKUS 100/50 was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for ADVAIR DISKUS 100/50

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	59
DailyMed Link:	ADVAIR DISKUS 100/50 at DailyMed

Recent Clinical Trials for ADVAIR DISKUS 100/50

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

Sponsor	Phase
Becro Ltd.	Phase 3
Teva Pharmaceuticals USA	Phase 3
Becro Ltd.	Phase 1

See all ADVAIR DISKUS 100/50 clinical trials

US Patents and Regulatory Information for ADVAIR DISKUS 100/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	AB	RX	Yes	Yes

Expired US Patents for ADVAIR DISKUS 100/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	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 DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	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 DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	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 DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000

EU/EMA Drug Approvals for ADVAIR DISKUS 100/50

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 ADVAIR DISKUS 100/50

See the table below for patents covering ADVAIR DISKUS 100/50 around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	841568
Austria	390611
Finland	990115
Spain	8305379
South Korea	100244004
Sweden	8101010
Finland	85011

Supplementary Protection Certificates for ADVAIR DISKUS 100/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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
0416951	C990012	Netherlands		PRODUCT NAME: SALMETEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN FLUTICASONPROPIONAAT,IN HET BIJZONDER SALMETEROLXINAFOAAT EN FLUTICASONPROPIONAAT; NATL REGISTRATION NO/DATE: RVG 23529 - RVG 23534 19990112; FIRST REGISTRATION: SE 14591 - 14596 19980907
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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111

Market Dynamics and Financial Trajectory for Advair Diskus 100/50

Last updated: November 4, 2025

Introduction

Advair Diskus 100/50, a combination inhaler comprising fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg), stands as a key therapy for asthma and chronic obstructive pulmonary disease (COPD). Its significant market share has been driven by its efficacy and established clinical profile. This report examines current market dynamics and projects the financial trajectory for Advair Diskus 100/50 amid evolving pharmaceutical landscapes, regulatory shifts, and competitive pressures.

Market Overview

Therapeutic Market Size and Segmentation

The inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) combination market serves over 200 million patients globally, with a significant share held by Advair. According to IQVIA, the global respiratory drug market surpassed $30 billion in 2022, with inhalers constituting over 70% of this segment[1].

Advair's primary markets include North America, Europe, and parts of Asia-Pacific. North America accounts for approximately 65% of the global revenue due to higher disease prevalence, better reimbursement, and established prescribing habits.

Key Drivers

• Rising Asthma and COPD Prevalence: The WHO estimates 262 million asthma cases and 251 million COPD cases worldwide, with prevalence expected to increase due to aging populations and environmental factors[2].

• Advancements in Inhaler Devices: Technological innovations improve patient compliance, which sustains demand.

• Guideline Endorsements: Clinical guidelines from GINA and GOLD favor ICS/LABA combinations like Advair for moderate to severe cases.

Challenges and Market Constraints

• Patent Expirations and Generic Competition: The original Advair disk underwent patent expiration in key markets, notably in the U.S. by 2019, leading to increased generic availability and price erosion[3].

• Regulatory Pressures: Agencies, including the FDA and EMA, emphasize inhaler safety, with some jurisdictions advocating for substitutable generic alternatives to reduce costs.

• Pricing Pressures: Payers aim to contain costs through formulary restrictions, favoring generics or alternative therapies.

Competitive Landscape

Generic Entrants and Biosimilars

Post patent expiry, generic manufacturers introduced cost-effective equivalents. The emergence of Advair generics significantly reduced the brand’s market share in the U.S., from over 60% pre-patent expiry to approximately 20% in 2022[4].

Innovative Alternatives

Newer combination inhalers, such as Advair's successors, incorporate novel delivery systems or dosing regimens. Examples include Dulera (mometasone/formoterol) and Breo Ellipta (fluticasone/vilanterol), which are gaining prescriber preference owing to convenience and potentially better efficacy profiles.

Market Consolidation and Partnerships

Major pharmaceutical firms have entered licensing agreements and launched authorized generics to maintain market presence. GSK (GlaxoSmithKline), Advair’s parent company, now emphasizes newer inhalers like Trelegy Ellipta, shifting focus from Advair.

Regulatory and Patent Trajectory

Patent Expiry and Litigation

Advair’s primary patents in the U.S. expired in 2019[3], triggering generics' emergence. GSK engaged in patent litigations to extend exclusivity but faced setbacks, opening market share to competitors.

Regulatory Developments

Regulators have authorized multiple generic versions, contributing to price competition. The FDA approved several generic Advair formulations, arguing for equivalent efficacy and safety, which pressures price and revenue streams.

Reimbursement and Pricing Policies

Payor policies increasingly favor generics; in the U.S., PBMs and insurers negotiate significant discounts, impacting Advair’s profitability. Besides, government-imposed price caps and value-based reimbursement models affect revenue forecasts.

Financial Trajectory Analysis

Historical Revenue Performance

Advair historically generated approximately $3-$4 billion annually globally[1]. Its peak in North America neared $2 billion pre-generic erosion. The patent cliff dramatically diminished sales, with revenues plummeting in 2020 and 2021.

Projected Post-Patent Revenue

• Short-term Outlook (2023-2025): Revenues are expected to stabilize at $500-$800 million annually in regions dominated by generics, assuming volume offset by lower pricing.

• Medium- to Long-term Outlook (2026-2030): As newer formulary preferences prevail and patent protections remain limited, Advair’s branded sales are projected further decline unless revitalized through reformulation or new indications.

Strategic Responses and Revenue Mitigation

GSK's shift to newer inhalers such as Trelegy Ellipta and investment in biologics suggest a pipeline and portfolio realignment to mitigate Advair’s declining revenues. Additionally, licensing of generic versions and expanding into emerging markets offer revenue diversification.

Impact of Market Trends

• Emerging Markets: Rapid urbanization and increased respiratory disease burden offer growth avenues, albeit with price-sensitive markets favoring generics.

• Digital and Remote Monitoring: Integration of digital inhaler technologies can enhance adherence and create premium value propositions, potentially generating premium pricing and revenue growth.

Future Outlook and Investment Considerations

While Advair Diskus 100/50 remains a cornerstone in respiratory care, its financial trajectory faces headwinds from patent expirations, generic competition, and evolving treatment paradigms. Continued investment in next-generation inhalers and strategic licensing might prolong its revenue contribution, but overall growth is likely to slow or decline.

Operators and investors should monitor regulatory approvals of generics, market adoption of new therapies, and technological innovations in inhaler design. Companies capable of integrating digital health solutions and expanding into underserved markets will mitigate some market shrinkage.

Key Takeaways

• The dominance of Advair in the respiratory therapy market has been eroded significantly post-patent expiry, with generics capturing a substantial market share.

• Market growth driven by rising respiratory disease prevalence is counterbalanced by intense price competition and regulatory pressures.

• Revenue forecasts indicate a continued decline for Advair’s branded sales in mature markets, with potential stabilization in emerging markets.

• Strategic shifts towards newer inhaler platforms and digital integration are critical for maintaining relevance and revenue streams.

• Investors and stakeholders should align with industry trends favoring innovation, cost containment, and global expansion to optimize returns.

FAQs

1. What factors contributed to the decline of Advair Diskus 100/50 sales?
   Patent expirations, increased generic competition, evolving clinical guidelines favoring alternative therapies, and price pressures from payers have driven sales decline.

2. How has the generic entry impacted Advair's market share?
   Post-2019, generic versions reduced Advair's market share in key regions from over 60% to roughly 20%, significantly impacting revenue.

3. What are the current strategies by GSK to offset declining Advair sales?
   GSK is focusing on newer inhalers like Trelegy Ellipta, licensing agreements, digital health integration, and expanding into emerging markets.

4. Are there any new formulations or indications that could revive Advair's market?
   Currently, no major reformulations or indications are pending; however, biosimilar and combination inhaler developments may influence future positioning.

5. What does the future hold for inhaler-based respiratory therapies?
   The market will likely see increased competition from novel inhaler devices, biologics, and digital health solutions, influencing the trajectory of existing therapies like Advair.

References

1. IQVIA. "Global Respiratory Market Report," 2022.
2. World Health Organization. "Global Surveillance, Prevention and Control of Chronic Respiratory Diseases," 2021.
3. U.S. Food and Drug Administration. "Advair (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol," 2019.
4. Evaluate Pharma. "Impact of Patent Expiries on Respiratory Drug Market," 2022.