Details for Patent: 6,656,935

Which drugs does patent 6,656,935 protect, and when does it expire?

Patent 6,656,935 protects STENDRA and is included in one NDA.

This patent has forty-one patent family members in twenty-five countries.

Summary for Patent: 6,656,935

Title:	Aromatic nitrogen-containing 6-membered cyclic compounds
Abstract:	An aromatic nitrogen-containing 6-membered cyclic compound of the formula (I): ##STR1## wherein Ring A is a substituted or unsubstituted nitrogen-containing heterocyclic group; R.sup.1 is a substituted or unsubstituted lower alkyl group, --NH--Q--R.sup.3 (R.sup.3 is a substituted or unsubstituted nitrogen containing heterocyclic group, and Q is a lower alkylene group or a single bond), or --NH--R.sup.4 (R.sup.4 is a substituted or unsubstituted cycloalkyl group); R.sup.2 is a substituted or unsubstituted aryl group; one of Y and Z is .dbd.CH--, and the other is .dbd.N--, or a pharmaceutically acceptable salt thereof, these compounds exhibiting excellent selective PDE V inhibitory activities, and hence, being useful in the prophylaxis or treatment of penile erectile dysfunction, etc.
Inventor(s):	Yamada; Koichiro (Saitama-ken, JP), Matsuki; Kenji (Saitama-ken, JP), Omori; Kenji (Saitama, JP), Kikkawa; Kohei (Kawaguchi, JP)
Assignee:	Tanabe Seiyaku Co., Ltd. (Osaka, JP)
Application Number:	09/925,892
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,656,935
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

United States Patent 6,656,935: A Detailed Analysis of Scope and Claims

Overview of the Patent

The United States Patent 6,656,935, titled "Aromatic nitrogen-containing 6-membered cyclic compounds," is a patent that covers a specific class of chemical compounds. These compounds are designed to inhibit phosphodiesterase V (PDE V), an enzyme implicated in erectile dysfunction.

Patent Scope

The scope of this patent is defined by the claims, which outline the specific characteristics and uses of the aromatic nitrogen-containing 6-membered cyclic compounds.

Chemical Structure

The patent describes compounds that are aromatic and contain a 6-membered cyclic ring with nitrogen. These compounds can be substituted with various groups such as alkyl, aryl, cycloalkyl, and alkylene groups[4].

Therapeutic Use

The primary therapeutic use of these compounds is in the treatment of erectile dysfunction (ED) and other related conditions like impotence. The compounds act by inhibiting the PDE V enzyme, which is a key regulator in the erectile process[4].

Pharmaceutical Compositions

The patent also covers pharmaceutical compositions that include these compounds as active ingredients, along with drug carriers and solvents. These compositions are designed for various administration routes, ensuring the effective delivery of the active compounds[4].

Claims

The patent includes 22 claims that delineate the specific aspects of the invention.

Independent Claims

The independent claims define the core of the invention, including the chemical structure of the compounds and their therapeutic applications. For example, Claim 1 describes the general structure of the aromatic nitrogen-containing 6-membered cyclic compounds[5].

Dependent Claims

The dependent claims further specify the substitutions, modifications, and uses of the compounds. These claims provide a detailed breakdown of the various chemical groups that can be attached to the core structure and the methods of treatment using these compounds[5].

Patent Landscape

Patent Expiration

The patent is set to expire on April 27, 2025. This expiration date marks the end of the exclusive rights granted to the patent holder to manufacture, use, and sell the invention[2].

Exclusivity

In addition to the patent, the FDA has granted exclusivity rights that extend beyond the patent expiration date. The exclusivity period, which includes revisions to the labeling to add the results of a clinical study, expires on October 18, 2025[2].

Generic Availability

A generic version of the drug, known as Stendra, has been approved by the FDA, but its commercial availability is not guaranteed immediately. This approval sets the stage for potential generic competition once the patent and exclusivity periods end[2].

Metrics for Measuring Patent Scope

Research on patent scope suggests that metrics such as independent claim length and independent claim count can be used to measure the breadth of a patent. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].

Impact on Innovation

The patent's scope and claims can influence innovation in the field. By defining a clear and specific area of protection, the patent encourages further research and development within the boundaries set by the claims. However, overly broad patents can lead to increased licensing and litigation costs, potentially diminishing innovation incentives[3].

Key Components and Groups

The patent highlights several key chemical groups and components:

• Heterocyclic Group: The core structure includes a heterocyclic group containing nitrogen.
• Alkyl and Aryl Groups: These groups can be substituted onto the core structure.
• Cycloalkyl and Alkylene Groups: These are additional substituents that can modify the compound.
• Salts and Pharmaceutical Compositions: The patent covers various salts and pharmaceutical compositions of these compounds[4].

Methods and Processes

The patent describes various methods related to the synthesis and use of these compounds, including chemical reactions and the use of solvents. The methods for treatment, including prophylaxis, are also outlined[4].

Conclusion

The United States Patent 6,656,935 is a comprehensive patent that covers a specific class of aromatic nitrogen-containing 6-membered cyclic compounds. The patent's scope is defined by its claims, which detail the chemical structure, therapeutic use, and pharmaceutical compositions of these compounds. With its expiration and exclusivity dates approaching, the landscape for generic competition is set to change.

Key Takeaways

• Chemical Structure: The patent covers aromatic nitrogen-containing 6-membered cyclic compounds.
• Therapeutic Use: Primarily for treating erectile dysfunction.
• Patent Expiration: April 27, 2025.
• Exclusivity: Expires on October 18, 2025.
• Generic Availability: Approved but not necessarily commercially available immediately.
• Metrics for Scope: Independent claim length and count are important metrics.

FAQs

What is the primary therapeutic use of the compounds described in US Patent 6,656,935?

The primary therapeutic use is in the treatment of erectile dysfunction (ED) and other related conditions like impotence.

When does the patent expire?

The patent is set to expire on April 27, 2025.

What is the significance of FDA exclusivity in this context?

FDA exclusivity grants the manufacturer sole marketing rights, which can run concurrently with the patent and extend beyond its expiration date.

How are the compounds synthesized according to the patent?

The patent describes various chemical reactions and the use of solvents in the synthesis of these compounds.

What are the key chemical groups mentioned in the patent?

The key groups include heterocyclic, alkyl, aryl, cycloalkyl, and alkylene groups.

Sources

1. US6656935B2 - Aromatic nitrogen-containing 6-membered cyclic compounds - Google Patents
2. Generic Stendra Availability - Drugs.com
3. Patent Claims and Patent Scope - SSRN
4. US6656935B2 - Aromatic nitrogen-containing 6-membered cyclic compounds - Google Patents
5. United States Patent 6,656,935 - Google APIs Storage

Drugs Protected by US Patent 6,656,935

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-001	Apr 27, 2012	AB	RX	Yes	No	6,656,935		Y	Y		TREATMENT OF ERECTILE DYSFUNCTION
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	AB	RX	Yes	No	6,656,935		Y	Y		TREATMENT OF ERECTILE DYSFUNCTION
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	AB	RX	Yes	Yes	6,656,935		Y	Y		TREATMENT OF ERECTILE DYSFUNCTION

Foreign Priority and PCT Information for Patent: 6,656,935

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	11-261852	Sep 16, 1999
Japan	2000-130371	Apr 28, 2000

International Family Members for US Patent 6,656,935

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1219609		92249	Luxembourg
European Patent Office	1219609		CA 2013 00040	Denmark
European Patent Office	1219609		C300618	Netherlands