AIRDUO DIGIHALER Drug Patent Profile

Which patents cover Airduo Digihaler, and when can generic versions of Airduo Digihaler launch?

Airduo Digihaler is a drug marketed by Teva Pharm and is included in one NDA. There are seven patents protecting this drug.

This drug has two hundred and thirty-seven patent family members in thirty-five countries.

The generic ingredient in AIRDUO DIGIHALER 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 Airduo Digihaler

A generic version of AIRDUO DIGIHALER was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for AIRDUO DIGIHALER

International Patents:	237
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Drug Prices:	Drug price information for AIRDUO DIGIHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AIRDUO DIGIHALER
What excipients (inactive ingredients) are in AIRDUO DIGIHALER?	AIRDUO DIGIHALER excipients list
DailyMed Link:	AIRDUO DIGIHALER at DailyMed

See drug prices for AIRDUO DIGIHALER

Pharmacology for AIRDUO DIGIHALER

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

US Patents and Regulatory Information for AIRDUO DIGIHALER

AIRDUO DIGIHALER is protected by seven US patents.

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	11,173,259*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		DISCN	Yes	No	11,969,544*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	10,918,816*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	9,066,957*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No	11,969,544*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No	11,173,259*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		DISCN	Yes	No	10,918,816*PED				Y

Expired US Patents for AIRDUO DIGIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019	6,701,917
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019	6,871,646
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019	8,006,690
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019	6,701,917
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019	8,006,690
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019	6,748,947
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019	6,718,972

EU/EMA Drug Approvals for AIRDUO DIGIHALER

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 AIRDUO DIGIHALER

See the table below for patents covering AIRDUO DIGIHALER around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	0115519
World Intellectual Property Organization (WIPO)	2011054527
Hong Kong	1222815	用於呼吸驅動的吸入器的順從性監控模塊 (COMPLIANCE MONITORING MODULE FOR A BREATH-ACTUATED INHALER)
Mexico	2017002551
Japan	2021000468
China	110167619
Mexico	2017009122	INHALADOR DE POLVO SECO CON PROPIONATO DE FLUTICASONA Y XINAFOATO DE SALMETEROL. (DRY POWDER INHALER COMPRISING FLUTICASONE PROPIONATE AND SALMETEROL XINAFOAT.)

Supplementary Protection Certificates for AIRDUO DIGIHALER

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

AIRDUO DIGIHALER: Patent Landscape and Market Trajectory

Last updated: February 19, 2026

What is AIRDUO DIGIHALER?

AIRDUO DIGIHALER is a combination inhaler containing the long-acting beta2-agonist (LABA) vilanterol and the inhaled corticosteroid (ICS) fluticasone furoate. It is indicated for the maintenance treatment of asthma in patients aged 12 years and older. The device delivers the two active pharmaceutical ingredients (APIs) in a dry powder formulation. Vilanterol works by relaxing the muscles in the airways, while fluticasone furoate reduces inflammation in the lungs.

What is the Patent Landscape for AIRDUO DIGIHALER?

The patent landscape for AIRDUO DIGIHALER is complex, involving patents on the APIs, the combination product, and the novel DIGIHALER device. Key patents and their expiration dates are critical for understanding market exclusivity and the potential for generic competition.

Core API Patents

The primary active ingredients, vilanterol and fluticasone furoate, are protected by separate patent families.

• Vilanterol: Patents covering vilanterol as a chemical entity and its therapeutic use have been granted. For example, U.S. Patent No. 7,407,970, assigned to Glaxo Group Limited, claims methods of treating respiratory diseases with vilanterol. This patent had an initial expiration date in 2025, but potential patent term extensions (PTEs) and adjustments could alter this.
• Fluticasone Furoate: Similarly, fluticasone furoate, a widely used ICS, has its own patent protection. U.S. Patent No. 7,442,709, also assigned to Glaxo Group Limited, claims fluticasone furoate and its use. This patent also has an initial expiration in 2025, subject to similar extension possibilities.

Combination Product Patents

Beyond individual APIs, patents protect the specific combination of vilanterol and fluticasone furoate for treating asthma. These patents often claim the synergistic effects or specific formulations that enhance efficacy or delivery.

• U.S. Patent No. 8,148,381: This patent, held by Glaxo Group Limited, claims a combination pharmaceutical product containing vilanterol and fluticasone furoate. The patent's expiration date is crucial. Its initial expiration is in 2028.

DIGIHALER Device Patents

A significant component of AIRDUO DIGIHALER's intellectual property lies in its novel delivery device, the DIGIHALER. This device is designed for ease of use and adherence monitoring. Patents in this area cover the mechanical aspects of the inhaler, its dispensing mechanism, and any integrated digital features.

• U.S. Patent No. 9,592,398: This patent claims an inhaler device for delivering medicaments, which is relevant to the DIGIHALER. The expiration date for such device patents can extend significantly beyond API patents, providing a longer period of market protection for the branded product. This patent is set to expire in 2031.
• Related Design and Utility Patents: Additional patents may cover specific design elements or improvements to the DIGIHALER device, further strengthening the intellectual property fortress around the product.

Exclusivity Periods

• Data Exclusivity: Following regulatory approval in major markets like the U.S. and EU, AIRDUO DIGIHALER benefits from statutory data exclusivity periods. In the U.S., this is typically 5 years for a new chemical entity and can be extended for New Combination Drugs or New Uses. In the EU, the period is 8 years of data exclusivity plus 2 years of market exclusivity, extendable by 1 year under certain conditions.
• Orphan Drug Exclusivity: Not applicable as AIRDUO DIGIHALER is not designated for rare diseases.
• Pediatric Exclusivity: In the U.S., if a company conducts pediatric studies as requested by the FDA, it can receive an additional 6 months of market exclusivity.

What is the Market Performance of AIRDUO DIGIHALER?

AIRDUO DIGIHALER, marketed by GlaxoSmithKline (GSK), competes in the crowded respiratory market. Its performance is influenced by its efficacy, the adoption of the DIGIHALER device, and the competitive landscape.

Sales Trajectory

GSK reported global net sales for AIRDUO (which includes the DIGIHALER device variant) as follows:

• 2022: £856 million
• 2021: £732 million
• 2020: £693 million

This indicates consistent year-over-year growth, driven by increased patient adoption and market penetration. The DIGIHALER device, in particular, is a key differentiator, aiming to improve adherence.

Geographic Breakdown

Sales are typically strongest in key developed markets where respiratory disease prevalence is high and healthcare systems are robust.

• United States: A significant contributor to sales, driven by physician prescribing and patient demand.
• Europe: Major European countries represent a substantial portion of revenue.
• Emerging Markets: Growth potential exists in these regions as access to advanced respiratory therapies expands.

Competitive Landscape

AIRDUO DIGIHALER faces competition from several established and emerging therapies in the asthma market, including:

• Other LABA/ICS Combinations: Products like Symbicort (budesonide/formoterol) from AstraZeneca and Advair (fluticasone/salmeterol) from GSK itself, though Advair is facing significant generic erosion.
• Triple Therapy Combinations: LABA/ICS/LAMA (long-acting muscarinic antagonist) products, such as Trelegy Ellipta (fluticasone furoate/vilanterol/umeclidinium) from GSK, offering expanded treatment options.
• Biologics: For severe asthma, treatments like Dupixent (dupilumab) from Sanofi/Regeneron and Tezspire (tezepelumab) from AstraZeneca/Amgen offer targeted therapies for specific asthma phenotypes.

Impact of Device Technology

The DIGIHALER's digital capabilities are intended to differentiate AIRDUO. Features like dose counting and potential for adherence tracking are designed to address a key challenge in respiratory therapy. The market's reception to these digital enhancements will be a crucial factor in its long-term success.

What are the Regulatory Status and Approval Dates?

Regulatory approvals in major markets are foundational to AIRDUO DIGIHALER's market access and commercialization.

United States

• FDA Approval: AIRDUO DIGIHALER received U.S. Food and Drug Administration (FDA) approval for asthma in November 2017. The approval was for adult and adolescent patients aged 12 years and older.

European Union

• EMA Approval: The European Medicines Agency (EMA) granted marketing authorization for AIRDUO DIGIHALER in July 2017. It is authorized for use in the EU for the maintenance treatment of asthma.

Other Key Markets

Approvals in other significant markets such as Japan, Canada, and Australia have followed, enabling global commercialization. The specific dates vary by country and regulatory body.

What is the Financial Trajectory and Future Outlook?

The financial trajectory of AIRDUO DIGIHALER is intrinsically linked to its patent exclusivity, market adoption, and competitive pressures.

Revenue Drivers

• Continued Market Penetration: As physicians and patients become more familiar with the DIGIHALER device and its benefits, prescription volumes are expected to increase.
• Growth in Developed Markets: Sustained demand in the U.S. and Europe will remain a primary revenue driver.
• Expansion in Emerging Markets: Strategic initiatives to increase access and affordability in emerging economies can unlock new growth avenues.

Patent Expirations and Generic Entry

The expiration of key patents, particularly for the APIs and the combination product, will pave the way for generic competition.

• First Wave of Generic Entry: Patents such as U.S. Patent No. 8,148,381 (expiring in 2028) are critical. Once these patents expire and any associated exclusivity periods lapse, generic manufacturers can seek approval for their versions.
• Impact of Device Patents: Patents on the DIGIHALER device itself may offer a longer period of protection, potentially delaying the full impact of generic competition compared to products relying solely on API patents. However, generic companies may develop alternative delivery devices.
• Projected Revenue Decline: Following the entry of generics, a significant decline in AIRDUO DIGIHALER's revenue is anticipated, similar to the pattern observed with other branded respiratory medications.

GSK's Strategic Response

GSK is likely to focus on maximizing revenue during the remaining exclusivity period. Strategies may include:

• Promoting the DIGIHALER Advantage: Emphasizing the device's unique features for adherence.
• Lifecycle Management: Exploring potential new indications or formulations.
• Portfolio Diversification: Investing in newer respiratory assets to offset future revenue erosion from older products.
• Global Market Access: Continuing to expand presence in markets with less mature generic landscapes.

Projected Sales Post-Patent Expiry

While specific projections are proprietary, historical market trends suggest that once significant generic competition emerges, branded sales of a LABA/ICS combination can drop by 60-80% within a few years. The DIGIHALER's device-specific patents might mitigate this decline to some extent by creating a barrier to entry for direct copies of the entire product. However, the availability of generic APIs will ultimately drive price erosion.

Key Takeaways

• AIRDUO DIGIHALER's patent protection is multi-layered, encompassing API patents, combination patents, and device patents, with the DIGIHALER device patents extending exclusivity until 2031.
• The drug has demonstrated consistent sales growth, reaching £856 million in global net sales in 2022.
• Key patent expirations, notably the combination product patent around 2028, signal the eventual entry of generic competitors.
• The DIGIHALER device's digital capabilities are a primary differentiator, aiming to improve patient adherence.
• Post-patent expiry, significant revenue decline is expected, necessitating strategic portfolio management by GSK.

FAQs

1. When do the core patents for vilanterol and fluticasone furoate expire? Core patents for vilanterol and fluticasone furoate initially expire in 2025, subject to potential patent term extensions.

2. What is the expiration date for the patent covering the AIRDUO DIGIHALER combination product? The patent covering the combination pharmaceutical product (U.S. Patent No. 8,148,381) is set to expire in 2028.

3. How do the DIGIHALER device patents affect the product's market exclusivity? Patents on the DIGIHALER device, such as U.S. Patent No. 9,592,398 expiring in 2031, extend the period of market exclusivity beyond the expiration of the API and combination product patents.

4. What were the total net sales for AIRDUO in 2022? Global net sales for AIRDUO in 2022 were £856 million.

5. What are the main competitive threats to AIRDUO DIGIHALER? Major competitive threats include other LABA/ICS combinations, triple therapy products, and newer biologic therapies for severe asthma.

Citations

[1] Glaxo Group Limited. (2010). U.S. Patent No. 7,407,970. Google Patents. Retrieved from https://patents.google.com/patent/US7407970B2/en

[2] Glaxo Group Limited. (2008). U.S. Patent No. 7,442,709. Google Patents. Retrieved from https://patents.google.com/patent/US7442709B2/en

[3] Glaxo Group Limited. (2012). U.S. Patent No. 8,148,381. Google Patents. Retrieved from https://patents.google.com/patent/US8148381B2/en

[4] Glaxo Group Limited. (2017). U.S. Patent No. 9,592,398. Google Patents. Retrieved from https://patents.google.com/patent/US9592398B2/en

[5] GlaxoSmithKline. (2023). Annual Report and Accounts 2022. Retrieved from https://www.gsk.com/en-gb/investors/reports/annual-report-2022/

[6] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/

[7] European Medicines Agency. (n.d.). Summary of Product Characteristics. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/airduo