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OMNARIS Drug Patent Profile

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

Omnaris is a drug marketed by Covis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fourteen patent family members in twelve countries.

The generic ingredient in OMNARIS 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 Omnaris

Omnaris 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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for OMNARIS

International Patents:	14
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	8
Patent Applications:	4,217
Drug Prices:	Drug price information for OMNARIS
What excipients (inactive ingredients) are in OMNARIS?	OMNARIS excipients list
DailyMed Link:	OMNARIS at DailyMed

See drug prices for OMNARIS

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

NDA:

022004

Dosage:

SPRAY, 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 OMNARIS

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
Takeda	Phase 3
AstraZeneca	Phase 3

See all OMNARIS clinical trials

Paragraph IV (Patent) Challenges for OMNARIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMNARIS	Nasal Spray	ciclesonide	50 mcg	022004	1	2012-02-13

US Patents and Regulatory Information for OMNARIS

OMNARIS 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	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006		RX	Yes	Yes

Expired US Patents for OMNARIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006

EU/EMA Drug Approvals for OMNARIS

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 OMNARIS

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

Country	Patent Number	Title	Estimated Expiration
Australia	2004271744	Use of ciclesonide for the treatment of respiratory diseases
New Zealand	501950	Medicinal compositions for application to mucosa
Colombia	5251406	UNA COMPOSICION FARMACEUTICA ACUOSA EN FORMA DE DISPERSION QUE CONTIENE CICLESONIDA E HIDROXIPROPILMETILCELULOSA QUE PRESENTA ESTABILIDAD MEJORADA DURANTE SU PRODUCCION
Norway	20021866
World Intellectual Property Organization (WIPO)	0128562
Japan	2003512329

OMNARIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omnaris

Introduction to Omnaris

Omnaris, along with its counterparts Alvesco and Zetonna, is a medication developed by AstraZeneca, utilizing the active ingredient ciclesonide, a synthetic corticosteroid. Omnaris is specifically designed as a nasal spray to treat nasal symptoms associated with seasonal allergic and allergic/non-allergic perennial rhinitis[1][3].

Market Context

The allergic rhinitis drugs market, within which Omnaris operates, is projected to grow from USD 1.90 billion in 2024 to USD 2.74 billion by 2034, at a CAGR of 3.8%. This growth is driven by increasing awareness about allergic reactions, the availability of various treatment options, and the rising incidence of allergic rhinitis due to factors such as increased tobacco usage[4].

Divestment and Ownership

In 2018, AstraZeneca entered into an agreement with Covis Pharma to divest the rights to Omnaris, along with Alvesco and Zetonna, for $350 million plus conditional sales-related payments of up to $21 million over four years. This deal included the rights for markets outside the US and US royalties, with Covis Pharma already commercializing these drugs in the US. This strategic move aligns with AstraZeneca's goal to focus resources on developing innovative new medicines to address unmet patient needs[1][3].

Financial Considerations

The transaction with Covis Pharma was significant for AstraZeneca's financial strategy. Here are some key financial points:

• Initial Payment: Covis Pharma paid AstraZeneca $350 million upon closing the deal[1][3].
• Conditional Payments: Additional payments of up to $21 million were agreed upon, conditional on sales performance over four years starting from 2019[1][3].
• Revenue Recognition: Since AstraZeneca would not maintain a significant ongoing interest in the medicines, the payments were recognized as Other Operating Income in the company’s financial statements[1][3].
• Historical Sales: In 2017, the combined sales of Alvesco, Omnaris, and Zetonna were $106 million[1][3].

Market Impact

The divestment of Omnaris and its related drugs has several implications for the market:

• Continued Patient Access: The agreement ensures that patients will continue to benefit from these medications, as Covis Pharma has strong capabilities in marketing medicines globally[1][3].
• Competitive Landscape: The allergic rhinitis drugs market is competitive, with prominent players including Ebastel, Nasacort, Grazax, Zyrtec, and others. The transfer of rights to Covis Pharma does not significantly alter the competitive dynamics but ensures continued market presence and potentially enhanced marketing efforts[4].

Pricing and Accessibility

The cost of Omnaris can vary, but it is generally around $320 for a supply of 12.5 grams, depending on the pharmacy. This pricing is for cash-paying customers and does not reflect prices with insurance plans[5].

Strategic Objectives of AstraZeneca

AstraZeneca's decision to divest Omnaris and other related drugs is part of a broader strategy:

• Focus on Innovation: By divesting older medicines, AstraZeneca aims to allocate resources more effectively towards developing innovative new medicines to address unmet patient needs[1][3].
• Financial Health: The divestitures, including the one with Covis Pharma, help AstraZeneca improve its financial health by generating significant cash inflows and reducing debt. This aligns with CEO Pascal Soriot’s goals to drive growth, improve profitability, and reduce debt[2].

Industry Expert Insights

Mark Mallon, Executive Vice President of Global Product and Portfolio Strategy at AstraZeneca, emphasized the strategic importance of divesting parts of their portfolio to focus on innovative medicines. Michael Porter, CEO of Covis Pharma, highlighted the significance of these medicines in the respiratory and allergy therapeutic area and the company's commitment to extending its reach globally[1].

Future Outlook

The future outlook for Omnaris, now under Covis Pharma, is promising given the growing demand for allergic rhinitis treatments. Here are some key points:

• Market Growth: The allergic rhinitis drugs market is expected to grow, driven by increasing awareness and the availability of effective treatments[4].
• Competitive Positioning: Covis Pharma's strong marketing capabilities and global reach are likely to maintain or enhance the market position of Omnaris and related drugs[1][3].

Key Takeaways

• Divestment Strategy: AstraZeneca's divestment of Omnaris and related drugs to Covis Pharma is part of a broader strategy to focus on innovative medicines and improve financial health.
• Financial Impact: The deal generated $350 million plus conditional payments for AstraZeneca, recognized as Other Operating Income.
• Market Presence: Covis Pharma's acquisition ensures continued patient access and potentially enhanced marketing efforts.
• Market Growth: The allergic rhinitis drugs market is projected to grow at a CAGR of 3.8% from 2025 to 2034.

FAQs

Q: What is the primary use of Omnaris? A: Omnaris is used as a nasal spray to treat nasal symptoms associated with seasonal allergic and allergic/non-allergic perennial rhinitis.

Q: Who acquired the rights to Omnaris from AstraZeneca? A: Covis Pharma acquired the rights to Omnaris, along with Alvesco and Zetonna, from AstraZeneca in 2018.

Q: What was the financial consideration for the divestment of Omnaris? A: Covis Pharma paid AstraZeneca $350 million upon closing, plus conditional sales-related payments of up to $21 million over four years.

Q: How does the divestment of Omnaris align with AstraZeneca's strategy? A: The divestment allows AstraZeneca to focus resources on developing innovative new medicines to address unmet patient needs.

Q: What is the projected growth rate of the allergic rhinitis drugs market? A: The allergic rhinitis drugs market is projected to grow at a CAGR of 3.8% from 2025 to 2034.

Sources

1. AstraZeneca Press Release: Divestment of rights to Alvesco, Omnaris and Zetonna to Covis Pharma[1].
2. FiercePharma: AstraZeneca offloads RSV drug to Sobi for $1.5B, its largest divestiture in the last five years[2].
3. BioSpace: AstraZeneca Unloads Three Asthma and Rhinitis Drugs to Covis Pharma for $350 Million[3].
4. Vantage Market Research: Future of Allergic Rhinitis Drugs Market: Size & Forecast 2032[4].
5. Drugs.com: Omnaris Prices, Coupons, Copay Cards & Patient Assistance[5].