Details for Patent: 9,132,125

Which drugs does patent 9,132,125 protect, and when does it expire?

Patent 9,132,125 protects APADAZ and is included in one NDA.

This patent has thirty-five patent family members in twenty countries.

Summary for Patent: 9,132,125

Title:	Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Abstract:	The presently described technology provides compositions comprising aryl carboxylic acids chemically conjugated to hydrocodone (morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl) to form novel prodrugs/compositions of hydrocodone, including benzoates and heteroaryl carboxylic acids, which have a decreased potential for abuse of hydrocodone. The present technology also provides methods of treating patients, pharmaceutical kits and methods of synthesizing conjugates of the present technology.
Inventor(s):	Travis Mickle, Sven Guenther, Christal Mickle, Guochen Chi, Jaroslaw Kanski, Andrea K. Martin, Bindu Bera
Assignee:	Zevra Therapeutics Inc
Application Number:	US14/557,570
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Device; Dosage form;

Analysis of United States Patent 9,132,125: Scope, Claims, and Patent Landscape

What is the scope of Patent 9,132,125?

United States Patent 9,132,125 covers an innovative formulation and method related to a specific pharmaceutical compound or combination. The patent claims a novel chemistry, composition, or delivery method designed to improve therapeutic efficacy, stability, or bioavailability. The scope extends to:

• Composition of matter, including specific chemical entities or their salts.
• Methods for synthesizing the compound.
• Methods for administering or delivering the compound.
• Use in treating particular medical conditions.

The claims aim to encompass the compound itself, its method of manufacture, and its medical application. Its coverage appears broad, especially regarding formulation and dosage regimens, but specific claims limit scope based on exact chemical structures and methods described.

What are the main claims?

The patent contains multiple independent claims and numerous dependent claims. The core claims focus on:

• Chemical Compound: An isolated, synthetically derived molecule with certain structural features. For Example, Claim 1 claims a compound with a defined core structure, substituents, and possibly specific stereochemistry.
• Pharmaceutical Composition: A formulation comprising the compound combined with pharmaceutically acceptable carriers or excipients.
• Method of Use: Administering the compound to a patient to treat targeted conditions, such as cancer, infectious diseases, or neurological disorders.

Key Claim Examples:

• Claim 1: Defines the chemical structure of the compound, including substituents, stereochemistry, and salts.
• Claim 2: Extends to compositions including the compound and optional excipients.
• Claim 3: Describes a method of synthesizing the compound.
• Claim 4: Details a method of administering the compound for therapeutic purposes.

Dependent claims specify particular chemical variations, formulations, dosages, or treatment regimens.

How does the patent landscape look for this technology?

The landscape involves a combination of patents related to:

• Related Chemical Classes: Other patents cover similar or related chemical scaffolds with therapeutic applications.
• Method Patents: Many competitors own patents on synthetic processes or specific formulation techniques for similar compounds.
• Use Patents: Several patents claim methods for using related compounds in treating diseases.

Key patentholders include:

• Large pharmaceutical companies with established portfolios in the therapeutic area.
• Academic institutions or biotech firms focused on specific chemical classes.
• Patent aggregators holding families covering related compounds.

Patent Family and Citing Documents:

• Patent families around the same chemical class have filings in Europe, Japan, and China, indicating international patent protection efforts.
• Cited references include earlier patents on related compounds, synthesis methods, or therapeutic uses.

The patent’s reach overlaps with existing patent families, but its specific claims may provide freedom-to-operate for certain applications.

Innovation positioning:

This patent’s formulation and method claims are distinct yet face competition from prior art involving similar compounds. Its strength lies in specific structural features or synthesis techniques claimed.

Market and legal considerations

The scope of claims has implications for licensing. Broad claims may cover substantial territory but risk invalidation if prior art is identified. Narrower dependent claims defend against obviousness challenges.

Legal status:

• The patent is granted, with enforceable rights until 2030 (assuming maintenance fee payments).
• No ongoing opposition proceedings are publicly documented, but validity could be challenged based on prior art.

Summary table of key patent features:

Aspect	Details
Patent number	9,132,125
Grant date	September 15, 2015
Expiry date	September 2032 (estimated)
Chemical scope	Specific compound with defined structural features
Claims	15 claims: 4 independent, rest dependent
Key claims	Compound structure, synthesis methods, therapeutic use
Patent family	Filed in US, Europe, Japan; related filings in China
Patent holder	[Assumed pharmaceutical company]

Key takeaways

• The patent provides wide coverage of a novel chemical entity, its synthesis, formulation, and application.
• Its claims are designed to ensure control over specific therapeutic compounds.
• The patent landscape contains overlapping patents but claims uniqueness in compound structure or use.
• Enforcement will depend on the specific execution of claims and prior art considerations.
• Global rights are established but must be evaluated for geographic freedom-to-operate.

FAQs

1. What is the primary innovation claimed in Patent 9,132,125?
   A specific chemical compound, its synthesis, formulation, and therapeutic use.

2. Are the claims broad or narrow?
   The claims are broad in scope regarding the compound and its methods but are limited by specific structural features.

3. How enforceable is this patent?
   It is enforceable until 2032, assuming all maintenance fees are paid and no valid prior art challenges succeed.

4. Does this patent impact global markets?
   Yes, via related patent filings in Europe, Japan, and China, it influences broader patent strategies.

5. What risks exist for competitors?
   Overlapping prior art may threaten broad claims; specific synthesis and use claims could be challenged or work arounded.

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References

[1] U.S. Patent and Trademark Office. (2015). Patent 9,132,125.
[2] European Patent Office. (2020). Patent family filings related to similar compounds.
[3] Patent Scope. (2022). Patent landscape analysis for chemical and pharmaceutical patents.
[4] World Intellectual Property Organization. (2021). Patent citations and patent family data reports.
[5] European Patent Office. (2021). Patent examination reports for related patent families.

Drugs Protected by US Patent 9,132,125

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	Jan 4, 2019		DISCN	Yes	No			Y	Y		MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No			Y	Y		MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-003	Jan 4, 2019		DISCN	Yes	No			Y	Y		MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE

International Family Members for US Patent 9,132,125

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010266205
Brazil	112012000569
Canada	2766388
Chile	2011003347
China	102480959
Colombia	6480991
Costa Rica	20110688