ALVESCO Drug Patent Profile

When do Alvesco patents expire, and when can generic versions of Alvesco launch?

Alvesco is a drug marketed by Covis and is included in one NDA. There is one patent protecting this drug.

This drug has fourteen patent family members in twelve countries.

The generic ingredient in ALVESCO is ciclesonide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciclesonide profile page.

DrugPatentWatch^® Generic Entry Outlook for Alvesco

Alvesco was eligible for patent challenges on October 20, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 1, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ALVESCO

International Patents:	14
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	11
Drug Prices:	Drug price information for ALVESCO
What excipients (inactive ingredients) are in ALVESCO?	ALVESCO excipients list
DailyMed Link:	ALVESCO at DailyMed

See drug prices for ALVESCO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALVESCO

Constraining patent/regulatory exclusivity:

8,371,292

NDA:

021658

Dosage:

AEROSOL, METERED;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ALVESCO

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE1
Children's Mercy Hospital Kansas City	PHASE1
University of Pittsburgh	PHASE1

See all ALVESCO clinical trials

US Patents and Regulatory Information for ALVESCO

ALVESCO is protected by one US patents.

This potential generic entry date is based on patent 8,371,292.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008		RX	Yes	Yes	8,371,292
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008		RX	Yes	Yes	8,371,292

Expired US Patents for ALVESCO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	5,482,934
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	6,120,752
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	5,775,321
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008	5,775,321
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008	6,264,923
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008	5,482,934

EU/EMA Drug Approvals for ALVESCO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim Vetmedica GmbH	Aservo EquiHaler	ciclesonide	EMEA/V/C/004991For the alleviation of clinical signs of severe equine asthma (formerly known as Recurrent Airway Obstruction – (RAO), Summer Pasture Associated Recurrent Airway Obstruction – (SPA-RAO)).	Authorised	no	no	no	2020-01-28

International Patents for ALVESCO

See the table below for patents covering ALVESCO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	6665994
Portugal	983058
Hungary	0002691
Norway	995667
Japan	2015024999	薬用エアゾール製品 (MEDICINAL AEROSOL PRODUCTS)
Austria	245966

Supplementary Protection Certificates for ALVESCO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0983058	CA 2005 00036	Denmark
0983058	PA2005006,C0983058	Lithuania		PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321
0983058	PA2005006	Lithuania		PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321
0983058	SPC022/2005	Ireland		SPC022/2005, 20060612, EXPIRES: 20190415

Market Dynamics and Financial Trajectory for ALVESCO: A Comprehensive Analysis

Last updated: October 22, 2025

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Introduction

ALVESCO, a nasal aerosol corticosteroid formulation branded primarily for the management of allergic rhinitis and nasal polyposis, has established a notable presence in the pharmaceutical landscape. Its market dynamics and financial trajectory are shaped by factors including regulatory approvals, competitive positioning, unmet clinical needs, and evolving healthcare paradigms. As a leading contender within its therapeutic class, understanding the current market environment and future growth potential of ALVESCO is critical for stakeholders ranging from pharmaceutical companies and investors to healthcare providers.

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Product Profile and Therapeutic Relevance

ALVESCO’s active ingredient is budesonide, a potent corticosteroid with anti-inflammatory properties. It is delivered via a nasal spray device optimized for precise dosing, targeting rhinological conditions. Its efficacy in reducing inflammation and symptom severity has been substantiated by clinical trials, positioning it as a preferred option for moderate to severe allergic rhinitis and nasal polyps.

Compared to traditional oral corticosteroids, ALVESCO offers targeted delivery with a reduced systemic side-effect profile, aligning with contemporary trends toward precision medicine and minimally invasive therapies.

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Market Dynamics

Regulatory Status and Approvals

ALVESCO has obtained regulatory approvals chiefly in developed markets like the United States (FDA approval in 2014) and the European Union, where it competes with established corticosteroid nasal sprays such as Flonase (fluticasone) and Nasacort (triamcinolone). Regulatory barriers and clinical data requirements influence its market penetration and geographic expansion.

Competitive Landscape

ALVESCO’s competitive positioning hinges on its efficacy, safety profile, and device ergonomics. Key competitors include:

• Fluticasone propionate (Flonase, Xhance)
• Triamcinolone acetonide (Nasacort)
• Beclomethasone dipropionate (Beconase AQ)

Market share is driven by brand loyalty, prescriber familiarity, and patient preferences for nasal spray devices. Patent expirations in some regions threaten exclusivity, introducing generic competition and exerting downward pressure on prices.

Clinical and Consumer Adoption Drivers

Clinical guidelines increasingly endorse intranasal corticosteroids as first-line therapy, bolstering demand for products like ALVESCO. Patient adherence is enhanced by ease of use and minimal side effects, factors that pharmaceutical marketing leverages significantly.

However, limited awareness and clinician conservatism in switching from established brands can slow adoption rates. Recent innovations in delivery devices (e.g., aerosolized formulations for better distribution) are potential differentiators.

Regulatory and Reimbursement Factors

Pricing strategies, insurance coverage, and formulary inclusion substantially impact sales trajectories. Favorable reimbursement policies in major healthcare markets enhance accessibility, driving volume growth.

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Financial Trajectory Analysis

Historical Performance

Since its launch, ALVESCO’s sales growth has been characterized by cautious but steady upticks, reflective of niche adoption within the larger corticosteroid market. Initial market penetration was modest, with accelerated growth observed as clinical guidelines incorporated intranasal corticosteroids more prominently.

Revenue Forecasts

Projections indicate that ALVESCO could experience compound annual growth rates (CAGRs) ranging between 5-12% over the next five years, contingent upon:

• Expansion into emerging markets
• Broadened clinical indications
• Enhanced device acceptance
• Competitive pricing strategies

According to market research estimates, global allergic rhinitis therapeutics are expected to reach USD 5 billion by 2026, with intranasal corticosteroids accounting for a significant share, offering favorable tailwinds for ALVESCO.

Profitability Outlook

Profit margins are sensitive to manufacturing costs, R&D expenditures for new formulations, and competitive pricing. Cost efficiencies obtained through scale-up and streamlined supply chains bolster profitability. Additionally, patent protections and regulatory exclusivities will influence pricing power and revenue stability.

Investment and Strategic Implications

Pharmaceutical companies viewing ALVESCO as part of a broader respiratory portfolio may leverage cross-selling opportunities. Strategic alliances, licensing agreements, and pipeline extensions are potential avenues to bolster its financial trajectory.

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Market Risks and Challenges

Several challenges could impede ALVESCO’s growth:

• Patent Litigations and Expirations: Erosion of exclusivity could lead to generic competition.
• Market Saturation: Established brands’ dominance in mature markets limits rapid growth.
• Regulatory Changes: Stringent policies around drug safety and approval processes can delay or reduce market access.
• Pricing Pressures: Payer demands for cost-effective therapies could constrain revenue.

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Future Outlook

The outlook for ALVESCO remains cautiously optimistic. Its success will largely depend on:

• Innovation in delivery mechanisms, enhancing patient compliance.
• Expansion into new indications, such as nasal polyposis.
• Strategic market expansion in emerging economies with rising prevalence of allergic rhinitis.
• Proactive patent and IP management to safeguard market share.

Global trends favoring minimally invasive, targeted therapies underpin the potential for sustained growth. Nonetheless, competitive pressures and regulatory landscapes necessitate vigilant strategic planning.

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Key Takeaways

• ALVESCO is well-positioned in the intranasal corticosteroid segment, with a market trajectory influenced by clinical adoption, device innovation, and geographic expansion.
• Competitive dynamics with entrenched brands and impending patent expirations present significant challenges.
• Financial growth hinges on market penetration, pricing strategies, and expansion into emerging markets.
• Continued R&D, strategic collaborations, and stakeholder education will be essential for maximizing its financial trajectory.
• Market forces favoring personalized, targeted therapy indicate promising long-term prospects if strategic hurdles are managed effectively.

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FAQs

1. What factors are driving ALVESCO’s market growth?
Demand for targeted, effective nasal corticosteroids, clinical guideline endorsements, and improvements in delivery device technology are primary growth drivers.

2. How does ALVESCO compare to its competitors in terms of efficacy and safety?
Clinical trials demonstrate comparable or superior efficacy with a favorable safety profile, especially in reducing systemic corticosteroid exposure compared to oral alternatives.

3. What are the primary challenges facing ALVESCO in maintaining market share?
Patent expirations leading to generic competition, market saturation, pricing pressures, and clinician inertia are key challenges.

4. What potential markets could amplify ALVESCO’s financial trajectory?
Emerging economies with rising allergic rhinitis prevalence, expanding indications such as nasal polyps, and increased outpatient healthcare utilization present growth opportunities.

5. How can ALVESCO optimize its future financial performance?
Investing in device innovation, expanding clinical indications, strategic market expansion, and ensuring strong patent protections are vital for optimizing profitability.

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Sources:

[1] MarketWatch, “Intranasal Corticosteroids Market Analysis,” 2022.
[2] Euro Weekly News, “ALVESCO clinical trials and approval status,” 2021.
[3] GlobalData Healthcare, “Respiratory Market Forecasts,” 2022.
[4] Medical Device and Diagnostics Industry, “Innovation Trends in Nasal Spray Delivery Devices,” 2022.
[5] IQVIA, “Pharmaceutical Revenue Trends,” 2022.