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ZETONNA Drug Patent Profile

Which patents cover Zetonna, and what generic alternatives are available?

Zetonna 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 ZETONNA 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 Zetonna

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 ZETONNA

International Patents:	14
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	1
Patent Applications:	4,217
Drug Prices:	Drug price information for ZETONNA
What excipients (inactive ingredients) are in ZETONNA?	ZETONNA excipients list
DailyMed Link:	ZETONNA at DailyMed

See drug prices for ZETONNA

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

NDA:

202129

Dosage:

AEROSOL, METERED;NASAL

^*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 ZETONNA

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

Sponsor	Phase
Sunovion	Phase 4

See all ZETONNA clinical trials

US Patents and Regulatory Information for ZETONNA

ZETONNA 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	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012		DISCN	Yes	No

Expired US Patents for ZETONNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012

EU/EMA Drug Approvals for ZETONNA

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 ZETONNA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	1100860
Australia	694606
Poland	191523
Australia	726835

Supplementary Protection Certificates for ZETONNA

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

ZETONNA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zetonna (Ciclesonide)

Introduction

Zetonna, a nasal aerosol formulation of ciclesonide, is a medication used for the treatment of allergic rhinitis. To understand its market dynamics and financial trajectory, it is essential to delve into the prevalence of the conditions it treats, market trends, and the strategic moves of the companies involved.

Prevalence of Allergic Rhinitis and Asthma

The high prevalence of allergic rhinitis and asthma is a significant driver for the demand of ciclesonide-based medications like Zetonna. According to the Global Asthma Report, asthma affects approximately 339 million people worldwide, and allergic rhinitis prevalence ranges from 15% to 25% among children, adolescents, and young adults in various regions[1].

Market Size and Growth

The global ciclesonide market, which includes Zetonna, was valued at US$ 565.4 million in 2018 and is expected to grow at a CAGR of 1.9% over the forecast period. The high prevalence of allergy rhinitis and asthma, particularly in regions like North America, is anticipated to drive this growth[1].

Regional Dominance

North America holds a dominant position in the global ciclesonide market, largely due to the high prevalence of allergy rhinitis and asthma in this region. The launch of Zetonna in the U.S. market in 2012, following FDA approval, has been a significant factor in this regional dominance[1].

Key Players and Market Strategies

AstraZeneca's Role

AstraZeneca was one of the key players in the ciclesonide market, including the rights to Zetonna. However, in 2018, AstraZeneca divested its rights to Zetonna, along with Alvesco and Omnaris, to Covis Pharma. This move was part of AstraZeneca's strategy to focus on developing innovative new medicines and address unmet patient needs[4][5].

Covis Pharma's Acquisition

Covis Pharma acquired the rights to Zetonna, Alvesco, and Omnaris for $350 million, plus conditional sales-related payments of up to $21 million over four years starting from 2019. This acquisition did not involve the transfer of any AstraZeneca employees or facilities. Covis Pharma, with its strong marketing capabilities, continues to commercialize these drugs globally[4][5].

Financial Impact of the Divestment

The divestment of Zetonna and other ciclesonide-based drugs to Covis Pharma resulted in a one-time payment of $350 million to AstraZeneca, recognized as Other Operating Income in their financial statements. This transaction did not affect AstraZeneca's financial guidance for 2018 but aligned with their strategy of reallocating resources to more innovative and high-potential areas[4][5].

Sales Performance

In 2017, the combined sales of Alvesco, Omnaris, and Zetonna were $106 million. While specific sales figures for Zetonna alone are not provided, this combined revenue indicates a significant market presence for these ciclesonide-based medications[4][5].

Competitive Landscape

The ciclesonide market is competitive, with other key players including Cipla Limited, Sun Pharmaceutical Industries Ltd., and Apotex Inc. The market dynamics are influenced by the launch of new products, generic competition, and regulatory approvals[1].

Future Outlook

The future outlook for Zetonna and the broader ciclesonide market is positive, driven by the increasing prevalence of allergic rhinitis and asthma. However, the market will also face challenges such as generic competition and the need for continuous innovation to maintain market share.

Regulatory Environment

Regulatory approvals and changes in healthcare policies can significantly impact the market trajectory of Zetonna. For instance, the FDA approval for Zetonna in 2012 was a crucial milestone for its market entry in the U.S.[1].

Patient Benefits and Market Sustainability

The agreement between AstraZeneca and Covis Pharma ensures that patients will continue to benefit from these medications. Covis Pharma's strong marketing capabilities and global reach are expected to sustain and potentially grow the market for Zetonna and other ciclesonide-based drugs[4][5].

Key Takeaways

• High Prevalence of Allergic Rhinitis and Asthma: Drives demand for ciclesonide-based medications like Zetonna.
• Regional Dominance: North America is a key market due to high disease prevalence.
• Strategic Divestment: AstraZeneca's divestment to Covis Pharma aligns with their innovation-focused strategy.
• Financial Impact: One-time payment of $350 million to AstraZeneca and ongoing sales-related payments.
• Competitive Landscape: Market is competitive with multiple key players.
• Future Outlook: Positive due to increasing disease prevalence, but faces generic competition and regulatory challenges.

FAQs

What is Zetonna used for?

Zetonna is a nasal aerosol formulation of ciclesonide used for the treatment of allergic rhinitis.

Who acquired the rights to Zetonna from AstraZeneca?

Covis Pharma acquired the rights to Zetonna, along with Alvesco and Omnaris, from AstraZeneca in 2018.

What was the financial consideration for the acquisition of Zetonna?

Covis Pharma paid AstraZeneca $350 million plus conditional sales-related payments of up to $21 million over four years starting from 2019.

How does the prevalence of allergic rhinitis and asthma impact the market for Zetonna?

The high prevalence of allergic rhinitis and asthma significantly drives the demand for ciclesonide-based medications like Zetonna.

What is the current market size and growth rate for ciclesonide-based medications?

The global ciclesonide market was valued at US$ 565.4 million in 2018 and is expected to grow at a CAGR of 1.9% over the forecast period.

Sources

1. Coherent Market Insights: Ciclesonide Market Size, Trends And Forecast To 2026
2. AstraZeneca: Year-to-date and Q3 2020 results
3. Sumitomo Pharma: Innovation today, healthier tomorrows - Annual Report 2016
4. AstraZeneca: Divestment of rights to Alvesco, Omnaris and Zetonna to Covis Pharma
5. BioSpace: AstraZeneca Unloads Three Asthma and Rhinitis Drugs to Covis Pharma for $350 Million