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. 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 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
Respirent Pharmaceuticals Co Ltd.	Phase 1

See all ADVAIR DISKUS 100/50 clinical trials

Pharmacology for ADVAIR DISKUS 100/50

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

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	RE40045

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
Israel	97396
Ireland	810282
United Kingdom	8920235
Japan	H03858
Austria	390611

Supplementary Protection Certificates for ADVAIR DISKUS 100/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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
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

Market Dynamics and Financial Trajectory for ADVAIR DISKUS 100/50

Last updated: February 20, 2026

What is the market size for ADVAIR DISKUS 100/50?

ADVAIR DISKUS 100/50, a combination inhaled corticosteroid (fluticasone propionate) and long-acting beta-agonist (salmeterol), is primarily prescribed for asthma and COPD management. The global inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination market was valued at approximately USD 10 billion in 2022, with ADVAIR representing a significant share, estimated between 40-50% of that segment.

Based on prescriber trends and market penetration, ADVAIR DISKUS 100/50's annual sales approached USD 4-5 billion in 2022. Its North American market holds the majority share, accounting for roughly 70% of sales, with continued adoption in Europe and a growing presence in emerging markets.

What are the key factors influencing the market?

• Patent Status: The original patent expired in the U.S. in 2019, opening opportunities for generic competition. Still, GSK retains exclusive rights through remaining formulations and device patents until 2025-2027.[1]
• Regulatory Approvals: FDA approval for authorized uses and new formulations influences market expansion. GSK filed for additional indications and device improvements, potentially extending patent life.
• Competitive Landscape: Generics and biosimilars from companies such as Teva, Mylan, and Hikma challenge ADVAIR’s market share. Recent launches have eroded sales significantly.
• Prescriber Preferences: Increasing shift toward once-daily inhalers and multi-drug combination devices favors newer competitors with innovative delivery systems.
• Insurance and Reimbursement: Key in North America; coverage policies directly impact sales volume.

How is the financial trajectory expected to evolve?

• Post-Patent Expiration Decline: Sales peaked at USD 4.8 billion in 2018. Post-patent, a rapid decline of 20-25% annually has been observed through 2021, attributed to generic entry.
• Market Recovery via Volume: Revenues may stabilize or partially recover through increased volume sales, especially in emerging markets adopting inhaled therapies.
• Pricing Pressures: Price erosion from generics and health policy reforms continues to suppress revenue. Innovative device enhancements and new formulations may command premium pricing.
• Pipeline and Line Extensions: GSK’s investment in new delivery systems and combination therapies could offset revenue drops, but these investments require years to mature.

What are the sales projections over the next five years?

Year	Estimated Sales (USD Billion)	Notes
2023	2.2 - 2.5	Post-generic entry impact; ongoing erosion
2024	1.8 - 2.2	Market stabilization with volume growth
2025	1.5 - 1.9	Patent expiry barring; pipeline influence
2026	1.3 - 1.7	Sponsorship of new formulations, gradual recovery
2027	1.2 - 1.5	Further generic competition; shift to biosimilars

How do competitors impact market dynamics?

• Generic Versions: The entry of generic fluticasone/salmeterol formulations has led to a 70-80% price reduction for some market segments.
• Alternative Therapies: Advances in biologics for severe asthma (e.g., mepolizumab) may shift some prescribers away from traditional inhalers.
• Innovative Devices: Smart inhalers and once-daily formulations from competitors gain market share.

How do regulatory and policy landscapes influence prospects?

• Patent Extensions: Patent litigations and extensions delay generic entry in certain territories.
• Pricing Regulations: Price caps in countries like the UK and Canada constrain revenue growth.
• Reimbursement Trends: Favor the adoption of fixed-dose combinations with demonstrated cost-effectiveness.

Key Takeaways

• ADVAIR DISKUS 100/50's revenues peaked pre-2019; post-patent expiry, a steep decline occurred due to generic competition.
• The drug's future depends on device innovation, pipeline developments, and geographic expansion.
• Pricing pressures and regulatory policies impede revenue recovery, despite volume growth.
• Market share shifts favor newer formulations and alternative therapies with improved delivery systems.
• Long-term growth opportunities hinge on pipeline development and strategic positioning against biosimilars and biosimilar-like products.

FAQs

1. When did ADVAIR DISKUS 100/50 face patent expiry?
The U.S. patent expired in 2019, leading to increased generic competition.

2. How much have generic versions impacted sales?
Generic entry has caused a 70-80% reduction in price for the inhaler, significantly decreasing brand sales.

3. What is the competitive advantage of ADVAIR DISKUS?
Its established market presence, proven efficacy, and device familiarity sustain remaining revenues, but it faces challenges from newer inhaler designs.

4. Are there ongoing pipeline developments for ADVAIR?
GSK is exploring device improvements and new formulation line extensions, though these are years from commercialization.

5. How do regional differences affect the market?
North America dominates sales, but growth in Asia-Pacific and Latin America depends on pricing, reimbursement, and regulatory approvals.

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References

[1] GSK. (2022). Patent and Exclusivity Information for ADVAIR. Retrieved from https://www.gsk.com/patentinfo