ADVAIR DISKUS 250/50 Drug Patent Profile

Which patents cover Advair Diskus 250/50, and when can generic versions of Advair Diskus 250/50 launch?

Advair Diskus 250/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in ADVAIR DISKUS 250/50 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 250/50

A generic version of ADVAIR DISKUS 250/50 was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for ADVAIR DISKUS 250/50

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 250/50 at DailyMed

Recent Clinical Trials for ADVAIR DISKUS 250/50

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 250/50 clinical trials

Pharmacology for ADVAIR DISKUS 250/50

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

US Patents and Regulatory Information for ADVAIR DISKUS 250/50

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 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000	AB	RX	Yes	Yes

Expired US Patents for ADVAIR DISKUS 250/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000	5,873,360*PED
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000	7,225,808*PED
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000	4,335,121*PED
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000	5,270,305*PED

EU/EMA Drug Approvals for ADVAIR DISKUS 250/50

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 250/50

See the table below for patents covering ADVAIR DISKUS 250/50 around the world.

Country	Patent Number	Title	Estimated Expiration
Czech Republic	285501	Balení léku pro použití v inhalačním přístroji (MEDICAMENT PACKAGE INTENDED FOR USE IN INHALING APPARATUS)
Ireland	51394	ANDROSTANE CARBOTHIOATES
South Korea	850000969
United Kingdom	2088877	ANDROSTANE 17 CARBOTHIOATES

Supplementary Protection Certificates for ADVAIR DISKUS 250/50

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	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
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

Market Dynamics and Financial Trajectory for ADVAIR DISKUS 250/50

Introduction to ADVAIR DISKUS 250/50

ADVAIR DISKUS 250/50 is a prescription medication used for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) and asthma. It combines an anti-inflammatory medicine (fluticasone propionate) and a long-acting bronchodilator (salmeterol), working together to improve lung function and reduce exacerbations[1][3][4].

Market Position and Competition

ADVAIR DISKUS 250/50 has been a significant player in the respiratory drug market, particularly in the treatment of COPD and asthma. However, the market dynamics have evolved with the introduction of generic versions.

• Generic Competition: The approval of generic versions of ADVAIR DISKUS, such as the one by Hikma Pharmaceuticals, has introduced competition into the market. This has led to price erosion, particularly in the US market, where generic drugs often lead to reduced pricing[2].
• Market Share: Despite the entry of generics, ADVAIR DISKUS remains a prominent brand, though its market share has been impacted. The presence of generics has forced the original manufacturer to adapt pricing strategies to maintain market presence.

Financial Performance

The financial trajectory of ADVAIR DISKUS 250/50 is influenced by several factors, including sales, pricing, and market competition.

• Revenue Trends: The revenue from ADVAIR DISKUS has seen fluctuations due to the introduction of generic competitors. For instance, Hikma Pharmaceuticals' financial reports indicate that while their generics segment, including the generic version of ADVAIR DISKUS, has seen significant margin improvements, the overall revenue from branded versions like ADVAIR DISKUS has been affected by price erosion[2].
• Pricing Erosion: The US market has experienced mid-single digit price erosion in recent years, which has impacted the revenue from ADVAIR DISKUS. This trend is expected to continue as more generic versions enter the market[2].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the financial trajectory of ADVAIR DISKUS.

• Increased Demand: There was some additional demand related to COVID-19, as respiratory conditions became more critical during the pandemic. However, this increased demand was not sufficient to offset the overall impact of generic competition[2].
• Supply Chain and Manufacturing: The pandemic also led to consolidation of manufacturing and distribution facilities, which helped in reducing costs but did not significantly boost revenue.

Regulatory Updates

Regulatory changes have also played a role in the market dynamics of ADVAIR DISKUS.

• Label Updates: The FDA has updated the labels for ICS/LABA combination products, including ADVAIR DISKUS, removing boxed warnings based on safety data reviews. This has helped in maintaining the drug's credibility and market position[5].

Clinical and Safety Profile

The clinical and safety profile of ADVAIR DISKUS is crucial for its market dynamics.

• Efficacy and Safety: ADVAIR DISKUS has been clinically proven to improve lung function and reduce COPD exacerbations. However, it is not indicated for the relief of acute bronchospasm and has associated risks such as pneumonia, particularly in older patients[1][3][4].
• Adverse Reactions: Common adverse reactions include headaches, nausea, and viral respiratory infections. These factors influence patient and prescriber preferences, impacting market dynamics.

Patient and Prescriber Preferences

Patient and prescriber preferences are key drivers of market dynamics.

• Brand Loyalty: Despite the availability of generics, some patients and prescribers may prefer the branded version due to its established reputation and clinical efficacy.
• Cost Considerations: The cost of treatment is a significant factor, with many patients opting for generic versions due to lower costs.

Geographic Performance

The performance of ADVAIR DISKUS varies across different geographic regions.

• US Market: The US market has seen significant price erosion due to generic competition. However, ADVAIR DISKUS remains a major player in this market[2].
• International Markets: In other regions, such as the Middle East and North Africa (MENA), the drug may still maintain a strong market position due to less generic competition and different regulatory environments[2].

Future Outlook

The future outlook for ADVAIR DISKUS 250/50 is influenced by several factors:

• Continued Generic Competition: The entry of more generic versions is expected to continue, leading to further price erosion.
• Innovative Strategies: The original manufacturer may need to adopt innovative strategies such as value-added services, patient support programs, and strategic pricing to maintain market share.
• Regulatory Changes: Any future regulatory changes or updates could impact the market dynamics and financial trajectory of the drug.

Key Takeaways

• ADVAIR DISKUS 250/50 remains a significant player in the respiratory drug market despite generic competition.
• Price erosion due to generics has impacted revenue.
• Regulatory updates and clinical efficacy continue to influence market dynamics.
• Patient and prescriber preferences, along with cost considerations, drive market decisions.
• The future outlook involves continued generic competition and the need for innovative strategies.

Frequently Asked Questions (FAQs)

Q: What is ADVAIR DISKUS 250/50 used for? A: ADVAIR DISKUS 250/50 is used for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) and asthma.

Q: How does ADVAIR DISKUS work? A: ADVAIR DISKUS combines an anti-inflammatory medicine (fluticasone propionate) and a long-acting bronchodilator (salmeterol) to improve lung function and reduce exacerbations.

Q: What are the common adverse reactions associated with ADVAIR DISKUS? A: Common adverse reactions include headaches, nausea, and viral respiratory infections.

Q: Has the introduction of generic versions affected the market for ADVAIR DISKUS? A: Yes, the introduction of generic versions has led to price erosion and impacted the revenue from ADVAIR DISKUS.

Q: What is the future outlook for ADVAIR DISKUS 250/50? A: The future outlook involves continued generic competition, and the original manufacturer may need to adopt innovative strategies to maintain market share.

Cited Sources

1. ADVAIR homepage | ADVAIR (fluticasone propionate and salmeterol)
   • https://www.advair.com
2. Better health. Within reach. Every day. - Hikma Pharmaceuticals
   • https://www.hikma.com/media/ylkpxepl/jpm-conference-presentation-vfinal.pdf
3. CENTER FOR DRUG EVALUATION AND RESEARCH
   • https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021077Orig1s057.pdf
4. Advair Diskus: Package Insert / Prescribing Information - Drugs.com
   • https://www.drugs.com/pro/advair-diskus.html
5. FDA approves US label update on ICS/LABA combinations in asthma based on review of safety data - GSK
   • https://www.gsk.com/en-gb/media/press-releases/fda-approves-us-label-update-on-icslaba-combinations-in-asthma-based-on-review-of-safety-data/