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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:	10
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

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
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 2/Phase 3
Covis Pharma S.à.r.l.	Phase 3
Danderyd Hospital	Phase 2

See all ALVESCO clinical trials

US Patents and Regulatory Information for ALVESCO

ALVESCO is protected by one US patents.

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
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008		RX	Yes	Yes

Expired US Patents for ALVESCO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008

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/004991 For 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
Brazil	1100860
Spain	2140943
Austria	245966
Australia	9167991

Supplementary Protection Certificates for ALVESCO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	CA 2005 00036	Denmark
0983058	SPC022/2005	Ireland		SPC022/2005, 20060612, EXPIRES: 20190415

ALVESCO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ALVESCO

Introduction to ALVESCO

ALVESCO, also known as ciclesonide, is a synthetic corticosteroid used primarily for the treatment of persistent asthma and nasal symptoms associated with allergic and non-allergic rhinitis. It is delivered via a metered-dose inhaler for asthma and as nasal sprays (Omnaris and Zetonna) for rhinitis.

Market Overview

The global ciclesonide market, which includes ALVESCO, is driven by the high prevalence of asthma and allergy rhinitis. According to the Global Asthma Report, asthma affects approximately 339 million people worldwide, and the prevalence is rising, especially in low- and middle-income countries[3].

Key Market Drivers

• High Prevalence of Asthma and Allergy Rhinitis: The widespread occurrence of these conditions, particularly in regions like North America, Europe, and parts of Asia, significantly drives the demand for ciclesonide-based medications[3][5].
• Increasing Medication Launches: New product launches and approvals, such as the FDA approval for Zetonna in 2012, have expanded the market reach and accessibility of ciclesonide products[3].
• Untapped Markets: There are opportunities for market penetration in regions where asthma and allergy rhinitis are prevalent but the availability of ciclesonide is limited, such as certain countries in the Asia-Pacific region[3].

Market Growth Projections

The ciclesonide market is expected to grow at a CAGR of 2.1% from 2022 to 2027, reaching a market size of approximately $671.7 million by 2027. This growth is attributed to the increasing application of ciclesonide to prevent symptoms of asthma and allergic rhinitis[5].

Geographical Market Share

North America holds the largest market share for ciclesonide, driven by the high prevalence of asthma and allergy rhinitis in the region. The Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period due to increasing awareness and accessibility of these medications[5].

Financial Performance of ALVESCO

Historical Sales Data

In 2017, the combined product sales of ALVESCO, Omnaris, and Zetonna recorded by AstraZeneca were $106 million. This figure indicates the significant revenue generated by these products before the divestment to Covis Pharma[1].

Divestment and Ownership

In November 2018, AstraZeneca divested its rights to ALVESCO, Omnaris, and Zetonna to Covis Pharma. This agreement included the rights to these medicines outside the US and US royalties. Covis Pharma, which already commercialized these products in the US, became the global owner upon the transaction's closing[1].

Impact on AstraZeneca’s Financials

The divestment was part of AstraZeneca's strategy to allocate resources to innovative new medicines. This move allowed AstraZeneca to focus on other strategic areas, contributing to its overall financial growth. For instance, AstraZeneca's total revenue increased by 41% in 2021, driven by growth in various strategic areas and the acquisition of Alexion[4].

Challenges and Opportunities

Generic Competition

The expiry of patents for branded ciclesonide products, such as Omnaris and ALVESCO, in October 2017, has led to the entry of generic manufacturers. This competition is expected to restrain market growth in terms of revenue as generic products are generally priced lower[3].

Alternative Medications

The availability of alternative medications that provide superior treatment for asthma and allergy rhinitis can impede the acceptance and growth of ciclesonide-based products. However, ciclesonide's unique properties, such as lower active steroids until the medication reaches the lungs, continue to make it a viable option[5].

Safety Concerns

Potential risks such as pneumonia and other respiratory infections among children using inhaled corticosteroids, including ciclesonide, can also impact market growth. However, the overall safety profile of ciclesonide, especially when used as directed, remains a positive factor[3].

End-User Segmentation

The ciclesonide market is segmented into adults and children. The adults segment holds the largest market share due to the increasing application of ciclesonide to prevent asthma attacks in adults. The children segment is expected to grow rapidly due to the safe and effective use of ciclesonide nasal sprays for perennial allergic rhinitis and asthma in children aged 12 and above[5].

Conclusion

The market dynamics for ALVESCO and other ciclesonide-based products are influenced by the high prevalence of asthma and allergy rhinitis, increasing medication launches, and the need to penetrate untapped markets. Despite challenges from generic competition and alternative medications, the ciclesonide market is projected to grow steadily.

Key Takeaways

• High prevalence of asthma and allergy rhinitis drives demand for ciclesonide.
• North America dominates the ciclesonide market, with the Asia-Pacific region showing the fastest growth.
• Generic competition and alternative medications pose challenges.
• The divestment of ALVESCO and related products to Covis Pharma aligns with AstraZeneca’s strategic objectives.
• The market is expected to grow at a CAGR of 2.1% from 2022 to 2027.

Frequently Asked Questions (FAQs)

1. What is ALVESCO used for?

ALVESCO (ciclesonide) is used for the treatment of persistent asthma and nasal symptoms associated with allergic and non-allergic rhinitis.

2. Who currently owns the rights to ALVESCO?

The rights to ALVESCO, along with Omnaris and Zetonna, were divested to Covis Pharma by AstraZeneca in November 2018.

3. What are the key drivers of the ciclesonide market?

The key drivers include the high prevalence of asthma and allergy rhinitis, increasing medication launches, and the need to penetrate untapped markets.

4. How is the ciclesonide market segmented?

The market is segmented by end-user into adults and children, and geographically into regions such as North America, Europe, Asia-Pacific, and others.

5. What challenges does the ciclesonide market face?

The market faces challenges from generic competition, alternative medications, and potential safety concerns related to inhaled corticosteroids.

Cited Sources:

1. AstraZeneca - Divestment of rights to Alvesco, Omnaris and Zetonna to Covis Pharma
2. Alvotech - Financial Results for the First Nine Months of 2024
3. Coherent Market Insights - Ciclesonide Market Size, Trends And Forecast To 2026
4. AstraZeneca - Full year and Q4 2021 results
5. IndustryARC - Ciclesonide Market Size Report, 2022-2027