Details for Patent: 8,371,292

Which drugs does patent 8,371,292 protect, and when does it expire?

Patent 8,371,292 protects ALVESCO, ZETONNA, and OMNARIS, and is included in three NDAs.

This patent has fourteen patent family members in twelve countries.

Summary for Patent: 8,371,292

Title:	Use of ciclesonide for the treatment of respiratory diseases
Abstract:	The invention relates to new method of treatment of respiratory diseases, in particular the treatment of asthmatic children.
Inventor(s):	Bethke; Thomas (Constance, DE), Engelstaetter; Renate (Allensbach, DE), Wurst; Wilhelm (Constance, DE)
Assignee:	Nycomed GmbH (Constance, DE)
Application Number:	10/571,311
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form; Delivery;

Detailed Analysis of the Scope and Claims of United States Patent 8,371,292

Overview of the Patent

United States Patent 8,371,292, titled "Use of ciclesonide for the treatment of respiratory diseases," is a significant patent in the pharmaceutical industry, particularly in the treatment of respiratory conditions. Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.

Inventors and Assignees

The patent was invented by Thomas Bethke, Renate Engelstaetter, and Wilhelm Wurst, and it is assigned to Nycomed GmbH, which is now part of the Covis Pharma group[4][5].

Publication and Issue Dates

The patent was issued on February 12, 2013, and its application number is US10/571,311[4][5].

Scope of the Patent

Respiratory Diseases Treatment

The patent focuses on a new method of treating respiratory diseases, with a particular emphasis on the treatment of asthma, especially in children. It covers the use of ciclesonide, a glucocorticoid, in various formulations for the treatment of respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), allergic rhinitis, and other related diseases[4].

Formulations and Administration

The patent describes various formulations of ciclesonide, including aerosol products, powders, and nasal drops. It also details the use of different propellants, cosolvents, and surface-active agents in these formulations. The methods of administration include inhalation and nasal spray, which are critical for the effective delivery of the drug to the respiratory tract[4].

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims are focused on the specific methods of treatment using ciclesonide, the compositions of the drug, and the dosages. For example, one of the claims describes the use of ciclesonide for treating asthma in children, specifying the dose and the formulation of the drug[4].

Dependent Claims

The dependent claims further elaborate on the independent claims by specifying additional details such as the type of propellants used, the concentration of the active ingredient, and the method of administration. These claims help to narrow down the scope and ensure that the patent covers a wide range of potential applications while maintaining specificity[4].

Patent Landscape

Patent Expiration

The patent is set to expire on February 1, 2028. This expiration date is crucial as it marks the end of the exclusive rights granted to the patent holder, allowing for the potential entry of generic versions of the drug into the market[2][5].

Legal Activities and Challenges

The patent has been subject to various legal activities, including maintenance fee payments, certificate of correction, and petition decisions. These activities are important as they can affect the patent's validity and expiration date. For instance, any successful opposition or litigation could potentially shorten the patent's life, while term extensions or amendments could prolong it[2].

International Protection

While the focus here is on the U.S. patent, it is important to note that ciclesonide and its formulations are protected by patents in multiple countries. Understanding the global patent landscape is crucial for strategizing market entry, especially for generic manufacturers looking to enter markets with weaker patent protection[2].

Impact on Generic Launch

As of now, there is no therapeutically equivalent generic version of Alvesco (the brand name for ciclesonide) available in the United States. The expiration of this patent in 2028 is expected to pave the way for generic versions, provided there are no further extensions or legal challenges that could delay this process[5].

Patent Scope and Quality

The scope of this patent, like many others, is a subject of debate in terms of patent quality. The length and clarity of patent claims are critical factors. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process, which could imply that this patent's claims have been carefully crafted to ensure validity and enforceability[3].

Conclusion

United States Patent 8,371,292 is a significant patent in the treatment of respiratory diseases, particularly asthma. Its scope covers a range of formulations and methods of administration for ciclesonide. The patent's expiration in 2028 will be a key milestone, potentially opening the door for generic versions of the drug. Understanding the patent landscape, including legal activities and international protections, is essential for both the patent holder and potential generic manufacturers.

Key Takeaways

• Patent Scope: Covers the use of ciclesonide for treating respiratory diseases, including asthma and allergic rhinitis.
• Formulations: Includes aerosol products, powders, and nasal drops.
• Expiration Date: February 1, 2028.
• Legal Activities: Subject to various legal activities that could affect its validity and expiration.
• International Protection: Protected by patents in multiple countries.
• Generic Launch: Expected to allow generic versions after the patent expires.

FAQs

Q: What is the primary use of ciclesonide as described in the patent? A: The primary use is for the treatment of respiratory diseases, particularly asthma, especially in children.

Q: What are the different formulations of ciclesonide covered by the patent? A: The patent covers aerosol products, powders, and nasal drops.

Q: When is the patent set to expire? A: The patent is set to expire on February 1, 2028.

Q: Are there any generic versions of Alvesco available in the U.S.? A: No, there are currently no therapeutically equivalent generic versions of Alvesco available in the United States.

Q: How do legal activities affect the patent's expiration date? A: Legal activities such as term extensions, amendments, or successful oppositions can affect the patent's expiration date, potentially shortening or prolonging its life.

Cited Sources

1. DrugBank: Ciclesonide: Uses, Interactions, Mechanism of Action.
2. Pharsight: Alvesco patent expiration.
3. Hoover Institution: Patent Claims and Patent Scope.
4. Google Patents: Use of ciclesonide for the treatment of respiratory diseases.
5. Drugs.com: Generic Alvesco Availability.

Drugs Protected by US Patent 8,371,292

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008		RX	Yes	Yes						MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A RESPIRATORY DISEASE IN A CHILD
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008		RX	Yes	Yes						MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A RESPIRATORY DISEASE IN A CHILD
Covis	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012		DISCN	Yes	No						TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHODS FOR TREATING A RESPIRATORY DISEASE IN A CHILD
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006		RX	Yes	Yes						TREATMENT OF NASAL SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER. TREATMENT OF NASAL SYMPTOMS ASSOCIATED W PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER

Foreign Priority and PCT Information for Patent: 8,371,292

PCT Information
PCT Filed	September 15, 2004	PCT Application Number:	PCT/EP2004/052172
PCT Publication Date:	March 24, 2005	PCT Publication Number:	WO2005/025578

International Family Members for US Patent 8,371,292

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004271744
Canada	2538419
Cyprus	1117371
Denmark	1670482
European Patent Office	1670482
Spain	2452691