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ADVAIR HFA Drug Patent Profile

When do Advair Hfa patents expire, and what generic alternatives are available?

Advair Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in ADVAIR HFA 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 Hfa

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

Summary for ADVAIR HFA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	84
Drug Prices:	Drug price information for ADVAIR HFA
Drug Sales Revenues:	Drug sales revenues for ADVAIR HFA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADVAIR HFA
What excipients (inactive ingredients) are in ADVAIR HFA?	ADVAIR HFA excipients list
DailyMed Link:	ADVAIR HFA at DailyMed

See drug prices for ADVAIR HFA

See drug sales revenues for ADVAIR HFA

Recent Clinical Trials for ADVAIR HFA

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

Sponsor	Phase
United States Department of Defense	Phase 1/Phase 2
University of Colorado, Denver	Phase 1/Phase 2
Becro Ltd.	Phase 3

See all ADVAIR HFA clinical trials

Pharmacology for ADVAIR HFA

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

US Patents and Regulatory Information for ADVAIR HFA

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 HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006		RX	Yes	Yes
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006		RX	Yes	Yes
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006		RX	Yes	Yes

Expired US Patents for ADVAIR HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006

EU/EMA Drug Approvals for ADVAIR HFA

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 ADVAIR HFA

See the table below for patents covering ADVAIR HFA around the world.

Country	Patent Number	Title	Estimated Expiration
Slovakia	284447
Denmark	0756868
Colombia	4830464	APARATO DISTRIBUIDOR
Austria	421315
Eurasian Patent Organization	001396	РАЗДАТОЧНОЕ УСТРОЙСТВО СО СЧЕТЧИКОМ ДОЗ (DISPENSER WITH DOSES' COUNTER)
Turkey	9701168
World Intellectual Property Organization (WIPO)	9856446

Supplementary Protection Certificates for ADVAIR HFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
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	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	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

ADVAIR HFA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Advair HFA

Introduction

Advair HFA, a cornerstone in the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD), has been a significant player in the pharmaceutical market since its launch in the late 1990s. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key events, challenges, and future outlook.

Historical Context and Launch

Advair HFA, developed by GlaxoSmithKline (GSK), was the first inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination to hit the market. It was first launched for asthma in the UK in 1999 and subsequently rolled out in Europe and other regions[5].

Market Dominance and Patent Protection

For many years, Advair HFA maintained its market dominance due to its innovative formulation and the complexity of its Diskus dry powder inhalation device. The patent estate surrounding Advair protected it from generic competition, allowing GSK to enjoy significant revenue from this product[1].

Impact of Generic Competition

The landscape changed dramatically with the launch of generic versions. Mylan's Wixela Inhub, a generic equivalent of Advair Diskus, was approved as a "substitutable" generic, meaning pharmacists could recommend it over the brand-name product. This led to a rapid erosion of Advair's market share. Within three weeks of Wixela's launch, it captured 24% of the market, rising to 28% by the end of April 2019[1].

Financial Impact on GSK

The introduction of generic competition had a profound financial impact on GSK. In the first quarter of 2019, GSK reported a significant decline in sales, with revenues dropping by £536 million (approximately $700 million) compared to the fourth quarter of the previous year. This decline was largely attributed to the aggressive discounting by Mylan, which drew market share away from Advair[1].

Stock Market Reaction

The financial results led to a 2% drop in GSK's London-traded shares immediately after the earnings release, although they recovered somewhat later in the day. The market's reaction underscored the significant impact of generic competition on GSK's financial performance[1].

Other Respiratory Products and Diversification

While Advair faced challenges, other respiratory products in GSK's portfolio showed mixed results. Nucala (mepolizumab) sales declined, but Trelegy (fluticasone furoate, umeclidinium, and vilanterol) saw modest improvements. GSK also emphasized growth in its HIV treatments and vaccines, such as Dovato (dolutegravir and lamivudine) and Shingrix (zoster vaccine), which helped offset some of the losses from Advair[1].

Oncology Pipeline and Future Growth

GSK has been investing heavily in its oncology pipeline, including the acquisition of Tesaro for $5.1 billion. Products like Zejula (niraparib) and the multiple myeloma treatment belantamab mafodotin are expected to contribute to future growth. These investments are part of GSK's strategy to mitigate the impact of generic competition in other areas of its portfolio[1].

Current Market and Sales Performance

As of recent years, GSK has reported mixed results. The company saw strong growth in vaccines, particularly Shingrix, which recorded a 72% increase in sales at actual exchange rates (AER) and 60% at constant exchange rates (CER) in 2022. However, the overall financial performance remains influenced by the ongoing impact of generic competition on Advair and other legacy products[2].

Cost and Pricing Dynamics

The cost of Advair, whether brand-name or generic, varies based on several factors including treatment plan, form of Advair, insurance coverage, and the pharmacy used. Generic versions, such as Wixela, have significantly reduced the cost for patients, making the treatment more accessible but also reducing GSK's revenue from Advair[3].

Environmental and Regulatory Considerations

Advair HFA, like other metered-dose inhalers (MDIs), uses hydrofluoroalkanes (HFAs) as propellants, which have environmental implications. The EPA has been monitoring the use of HFCs in MDIs, noting that while they are more appropriate for certain patients, their use is expected to continue with a growth rate aligned with population growth[4].

Key Takeaways

• Generic Competition: The launch of generic versions, particularly Mylan's Wixela, significantly impacted Advair's market share and GSK's revenues.
• Financial Impact: The decline in Advair sales led to a substantial drop in GSK's revenues and affected its stock performance.
• Diversification: GSK is diversifying its portfolio with investments in oncology, HIV treatments, and vaccines to offset losses from legacy products.
• Cost and Pricing: The cost of Advair varies widely, and generic versions have made the treatment more affordable but reduced GSK's revenue.
• Regulatory and Environmental Considerations: The use of HFCs in MDIs continues, with ongoing regulatory and environmental monitoring.

FAQs

Q: What was the impact of generic competition on Advair's market share? A: The launch of Mylan's Wixela led to Advair losing significant market share, with Wixela capturing 24% of the market within three weeks and rising to 28% by the end of April 2019[1].

Q: How did the introduction of generics affect GSK's financial performance? A: The introduction of generics led to a £536 million (approximately $700 million) decline in GSK's revenues in the first quarter of 2019 compared to the fourth quarter of the previous year[1].

Q: What other products is GSK relying on for future growth? A: GSK is investing in its oncology pipeline, including products like Zejula and belantamab mafodotin, as well as HIV treatments and vaccines such as Dovato and Shingrix[1].

Q: How does the cost of Advair vary? A: The cost of Advair varies based on factors such as treatment plan, form of Advair, insurance coverage, and the pharmacy used[3].

Q: What are the environmental implications of Advair HFA? A: Advair HFA uses HFCs as propellants, which have environmental implications. The EPA monitors the use of HFCs in MDIs, noting their continued use aligned with population growth[4].

Sources

1. BioPharma Dive - Generic Advair hits GSK revenues hard
2. GSK - Full-year and fourth quarter 2022 results announcement
3. Medical News Today - Advair cost 2024: Coupons and more
4. EPA - Market Characterization of the U.S. Metered Dose Inhaler Industry
5. Business Wire - Global Analysis on Advair (GlaxoSmithKline) 2017-2026