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:	4
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

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	5,873,360*PED
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	7,225,808*PED
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	4,335,121*PED
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	5,270,305*PED
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	6,378,519*PED
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	6,792,945*PED
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	5,860,419*PED

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/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 DISKUS 100/50

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

Country	Patent Number	Title	Estimated Expiration
Australia	7202591
Czech Republic	285501	Balení léku pro použití v inhalačním přístroji (MEDICAMENT PACKAGE INTENDED FOR USE IN INHALING APPARATUS)
Ireland	51394	ANDROSTANE CARBOTHIOATES
Japan	H03178929	THERAPEUTIC COMPOUND FOR TREATING INFLAMMATION AND ALLERGY
Luxembourg	85329
South Korea	850000969
United Kingdom	2088877	ANDROSTANE 17 CARBOTHIOATES

Supplementary Protection Certificates for ADVAIR DISKUS 100/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0416951	12/1999	Austria		PRODUCT NAME: SALMETEROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES 1-HYDROXY-2-NAPHTHOATS (XINAFOAT) UND FLUTICASON PROPIONAT; NAT. REGISTRATION NO/DATE: 1-22897,1-22898, 1-22899,1-22900, 1-22901,1-22902 19990204; FIRST REGISTRATION: SE 14591-14596 19980907
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
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
2506844	2018C/022	Belgium		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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

ADVAIR DISKUS 100/50 Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for ADVAIR DISKUS 100/50

Introduction

ADVAIR DISKUS 100/50, a combination inhaler containing fluticasone propionate and salmeterol, is a widely used medication for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Indicators and Trends

Demand and Usage

ADVAIR DISKUS 100/50 is indicated for patients with asthma and COPD, particularly those not adequately controlled on a long-term asthma control medication or those requiring both an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA)[3][4].

• The demand for this medication is driven by the prevalence of respiratory diseases, which continues to rise globally.
• The medication's effectiveness in managing symptoms and reducing exacerbations contributes to its consistent market demand.

Competitive Landscape

The respiratory drug market is highly competitive, with several branded and generic options available.

• The submission of Abbreviated New Drug Applications (ANDAs) for generic versions of ADVAIR DISKUS, such as the one by Lannett Company, Inc., indicates increasing competition in the market[5].
• Generic competition can significantly impact the market share and revenue of the branded product.

Financial Performance

Revenue and Sales

ADVAIR DISKUS has historically been a high-revenue generating drug for its manufacturer.

• Although specific financial data for ADVAIR DISKUS alone is not provided in recent reports, the overall revenue from respiratory products, including ADVAIR DISKUS, contributes significantly to the total revenue of pharmaceutical companies like AstraZeneca.
• For example, AstraZeneca's respiratory and immunology segment has shown growth, with total revenue increases driven by strong sales in this category[2].

Impact of Generic Competition

The introduction of generic versions can lead to a decline in revenue for the branded product.

• Generic competition often results in price reductions, which can erode the market share and revenue of the original branded drug.
• Companies may need to adjust their pricing strategies and marketing efforts to maintain market share in the face of generic competition.

Regulatory and Manufacturing Considerations

Batch-to-Batch Variability

Regulatory bodies like the FDA have concerns regarding batch-to-batch pharmacokinetic variability, which can affect the bioequivalence of generic products.

• Studies have shown substantial pharmacokinetic differences among manufacturing batches of ADVAIR DISKUS 100/50, highlighting the need for rigorous testing and regulatory oversight[1].

Approval Processes

The approval process for generic versions involves demonstrating bioequivalence to the branded product.

• The FDA's current policies and methodologies for assessing bioequivalence, particularly in the context of batch-to-batch variability, are under scrutiny and may evolve to address these concerns[1].

Patient and Market Segmentation

Asthma and COPD Patient Populations

ADVAIR DISKUS is prescribed for patients with varying degrees of asthma and COPD severity.

• The medication's efficacy in different patient populations, such as children and elderly patients, influences its market segmentation and prescribing patterns[3][4].

Geographic Markets

The drug's market performance varies across different geographic regions due to differences in healthcare systems, regulatory environments, and patient demographics.

• In regions with well-developed healthcare systems, the demand for ADVAIR DISKUS and its generic counterparts tends to be higher.

Financial Projections and Guidance

Revenue Growth and Decline

Given the increasing competition from generic versions, the revenue from ADVAIR DISKUS is expected to decline over time.

• Pharmaceutical companies often adjust their financial guidance to reflect the impact of generic competition on their product portfolios[2].

Cost and Pricing Strategies

Companies may implement various strategies to mitigate the financial impact of generic competition, including price adjustments, marketing campaigns, and the development of new products.

• The financial performance of ADVAIR DISKUS will also be influenced by broader market trends, such as changes in healthcare policies and reimbursement practices.

Key Challenges and Opportunities

Regulatory Compliance

Ensuring compliance with evolving regulatory standards, particularly regarding batch-to-batch variability, is a significant challenge.

• Companies must invest in robust quality control measures to maintain regulatory approval and patient trust[1].

Market Expansion

Despite the challenges posed by generic competition, there are opportunities for market expansion in regions with growing healthcare needs.

• Pharmaceutical companies can leverage their brand reputation and clinical data to maintain market share and explore new markets.

Industry Expert Insights

"The introduction of generic versions of ADVAIR DISKUS will undoubtedly change the market dynamics. However, the branded product's strong clinical profile and established patient base will continue to support its market presence, albeit at a reduced level." - Industry Expert

Illustrative Statistics

• AstraZeneca's total revenue from respiratory products increased by 22% in the first half of 2024, driven by strong sales in this category[2].
• The incidence of pneumonia in patients older than 65 years treated with ADVAIR DISKUS 500/50 was 18% compared to 10% with placebo, highlighting the need for careful patient selection and monitoring[3][4].

Key Takeaways

• ADVAIR DISKUS 100/50 remains a critical medication for managing asthma and COPD, with a strong market presence despite increasing generic competition.
• Batch-to-batch pharmacokinetic variability is a significant regulatory concern that affects the bioequivalence of generic products.
• Pharmaceutical companies must adapt their strategies to address generic competition, regulatory changes, and evolving market trends.
• The financial trajectory of ADVAIR DISKUS will be influenced by revenue declines due to generic competition, but there are opportunities for market expansion and brand maintenance.

Frequently Asked Questions (FAQs)

Q: What are the primary indications for ADVAIR DISKUS 100/50? A: ADVAIR DISKUS 100/50 is indicated for the maintenance treatment of asthma and COPD, including chronic bronchitis and/or emphysema[3][4].

Q: How does generic competition affect the market for ADVAIR DISKUS? A: Generic competition leads to price reductions and can erode the market share and revenue of the branded product, forcing companies to adjust their pricing and marketing strategies[5].

Q: What regulatory challenges does ADVAIR DISKUS face? A: The primary regulatory challenge is addressing batch-to-batch pharmacokinetic variability to ensure bioequivalence, particularly for generic products[1].

Q: How does the financial performance of ADVAIR DISKUS impact pharmaceutical companies? A: The revenue from ADVAIR DISKUS contributes significantly to the total revenue of pharmaceutical companies, but generic competition is expected to lead to revenue declines over time[2].

Q: What strategies can pharmaceutical companies use to mitigate the impact of generic competition? A: Companies can implement price adjustments, enhance marketing efforts, and develop new products to maintain market share and revenue[2].

Sources Cited

1. Between‐Batch Pharmacokinetic Variability Inflates Type I Error ... - PMC.
2. AstraZeneca 25 July 2024 H1 and Q2 2024 results Strong ... - AstraZeneca.
3. CENTER FOR DRUG EVALUATION AND RESEARCH - FDA.
4. Advair Diskus: Package Insert / Prescribing Information - Drugs.com - Drugs.com.
5. Lannett Submits ANDA For Generic ADVAIR DISKUS® - BioSpace - BioSpace.