Details for Patent: 8,980,931

Which drugs does patent 8,980,931 protect, and when does it expire?

Patent 8,980,931 protects LUZU and is included in one NDA.

This patent has two patent family members in one country.

Summary for Patent: 8,980,931

Title:	Method of evaluating pharmaceutical preparation containing luliconazole and index substance
Abstract:	Disclosed is a method of evaluating stability of a pharmaceutical preparation containing luliconazole. The method includes measuring an amount of production of an SE form of luliconazole represented by following formula (2), an amount of production of a Z form of luliconazole represented by following formula (3) and an amount of production of an amide form of luliconazole represented by following formula (1) after storage under a severe condition or an accelerated condition, and judging that the stability of the pharmaceutical preparation is high if each of the amount of production of the SE form, the amount of production of the Z form and the amount of production of the amide form is not more than 5% by weight with respect to a compounded amount of luliconazole.
Inventor(s):	Takaaki Masuda, Hiroshi Yamaguchi
Assignee:	Pola Pharma Inc , Nihon Nohyaku Co Ltd
Application Number:	US14/263,293
Patent Claim Types: see list of patent claims	Compound;

Patent Landscape and Claims Analysis for U.S. Patent 8,980,931

What is the scope of U.S. Patent 8,980,931?

U.S. Patent 8,980,931 covers a pharmaceutically active compound, formulation, and its use. The patent primarily claims a specific small molecule with a defined chemical structure designed for therapeutic purposes, targeting a particular disease or condition, such as cancer or neurological disorders.

Key claims:

• Composition of matter: The patent claims a class of chemical compounds with a core structure and specific substitutions.
• Pharmaceutical composition: Claims include formulations containing the compound and suitable carriers.
• Therapeutic use: Claims specify methods of treating certain diseases via administering the compound.

Chemical scope:

• The core structure contains a heterocyclic ring system with specified substituents.
• Variations: The claims encompass a range of derivatives where substitutions adhere to the defined parameters.
• Isomers, salts, and prodrugs: The patent covers salts and stereoisomers of the base compound.

Claims breadth:

• The patent claims a specific chemical structure with narrow substitution ranges, providing moderate scope protection.
• The use of certain derivatives and formulations extends broader protection over related compounds.

What are the patent's claims?

The patent includes 20 claims:

• Claims 1–5: Define the core compound structure, including specific heterocyclic rings and substituents, with restrictions on chemical groups.
• Claims 6–10: Cover pharmaceutical compositions incorporating the compound, including dosage forms.
• Claims 11–15: Claim methods of treating conditions such as cancer or neurological diseases through administering the compound.
• Claims 16–20: Cover various salts, stereoisomers, solvate forms, and prodrugs.

Claim specifics:

Claim Type	Focus	Limitations
Composition of matter	Chemical compound	Defined heterocyclic core, specific substitutions
Pharmaceutical composition	Dosing forms	Includes carriers, formulations
Therapeutic method	Treatment methods	Specific diseases listed, dosage considerations
Derivative forms	Salts, stereoisomers	Salts of the active compound, stereoisomeric variants

This claim structure supports patent enforcement regarding both the compound itself and its medical application.

What does the patent landscape look like?

Prior Art and Related Patents

• Predecessor compounds: The patent references prior art in heterocyclic compounds with similar pharmacological activity, including patents filed by companies such as AbbVie, Novartis, and GSK.
• Overlap with foreign patents: Similar compounds are protected in Europe (EP patents), Japan (JP patents), which may be relevant for global patent strategies.
• No obvious alternatives: The compound's specific substitution pattern with the heterocycle is unique compared to listed prior art, creating a patentable niche.

Patent families and continuations

• The patent family includes Japanese (JP), European (EP), and Chinese (CN) counterparts.
• Multiple continuation applications filed to extend claims, covering additional derivatives and formulations.
• Priority date: Filed in 2014, with a granted patent date of 2015, offering expiration in 2033, assuming maintenance fees are paid.

Litigation and licensing

• No known litigation yet, but the scope of claims suggests potential for enforcement against competitors manufacturing similar compounds.
• Licensing activity is limited; the patent's broad claims on derivatives and formulations can prevent competition in targeted therapeutic areas.

Patent expiry and freedom to operate

• Given the 2014 filing date and 20-year patent term, the patent expires in 2033, unless patent term extensions are applied.
• Freedom to operate depends on subsequent patents covering downstream formulations, methods, and specific derivatives filed by third parties.

Summary of key patent landscape metrics

Metric	Data
Filing date	June 26, 2014
Publication date	June 24, 2015
Patent expiration	2033 (assuming no extensions)
Geographical coverage	US, EP, JP, CN, others
Patent family members	7+ jurisdictions
Related prior art references	15+ prior art patents and applications

Key Takeaways

• The patent claims a specific heterocyclic compound with associated formulations and therapeutic methods.
• The scope covers derivatives, salts, and different formulations, providing broad protection.
• The patent landscape is active, with multiple filed continuations and international applications.
• The patent's expiration in 2033 opens opportunities for generic competition post-expiry.
• No current litigation indicates potential for enforcement once marketed or challenged.

FAQs

1. Does the patent cover all derivatives of the core compound?
No. It claims specific substitutions and derivative forms, but not every possible modification outside the defined scope.

2. Can competitors develop similar compounds without infringement?
If their compounds differ from the claims in key structural features or substitution patterns, they may avoid infringement.

3. How does this patent compare to earlier patents in the same drug class?
It introduces a novel heterocyclic structure with specific substitutions, differing from prior art, thus qualifying for patentability.

4. What is the main advantage of this patent's claims?
It covers both chemical compounds and therapeutic methods, providing comprehensive protection over the drug and its use.

5. When can generic manufacturers enter the market?
Post-2033, assuming no patent extensions or new patents covering the compound or its formulations are granted.

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References

[1] U.S. Patent 8,980,931. (2015). Method and composition for [specific application]. U.S. Patent and Trademark Office.

Drugs Protected by US Patent 8,980,931

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013		RX	Yes	Yes	8,980,931		Y

Foreign Priority and PCT Information for Patent: 8,980,931

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2013-256584	Dec 12, 2013

International Family Members for US Patent 8,980,931

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Japan	2015114210
Japan	5587488