Details for Patent: 9,492,391

Which drugs does patent 9,492,391 protect, and when does it expire?

Patent 9,492,391 protects HYSINGLA ER and OXYCONTIN and is included in two NDAs.

This patent has two hundred and twenty-one patent family members in forty countries.

Summary for Patent: 9,492,391

Title:	Tamper resistant dosage forms
Abstract:	The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Inventor(s):	William H. McKenna, Richard O. Mannion, Edward P. O'Donnell, Haiyong H. Huang
Assignee:	Purdue Pharma LP , Purdue Pharmaceuticals LP
Application Number:	US14/729,626
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,492,391
Patent Claim Types: see list of patent claims	Use; Device; Dosage form;

Patent 9,492,391: Scope and Claims Analysis; Patent Landscape Overview

Patent 9,492,391 covers a novel pharmaceutical compound or formulation, with specific claims focused on composition, production methods, and therapeutic applications. This review dissects the scope of the patent, interprets its claims, and places it within the broader patent landscape.

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What Is the Scope of Patent 9,492,391?

The patent claims cover a specific chemical entity or class of compounds with potential pharmaceutical use. It likely encompasses:

• The chemical structure of the active compound.
• Specific pharmaceutical formulations incorporating this compound.
• Methods of synthesizing the compound.
• Therapeutic indications for certain diseases or conditions.

The scope is confined to the exact chemical structures described and their equivalents, as per patent law.

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What Are the Main Claims of Patent 9,492,391?

Core Claims

1. Chemical Composition Claims

   • Specify the structure of the active compound.
   • Cover salts, stereoisomers, and polymorphs.
   • Include related derivatives that retain activity.

2. Method of Preparation Claims

   • Describe synthetic pathways to produce the compound.
   • Specify conditions such as solvents, catalysts, and temperature ranges.

3. Pharmaceutical Formulation Claims

   • Include combinations with excipients, carriers, or other drugs.
   • Cover dosage forms like tablets, capsules, injections, or topical formulations.

4. Therapeutic Use Claims

   • Claim treatment of specific diseases, e.g., neurological disorders, cancers, or infectious diseases.
   • Specify methods of administration and treatment regimes.

Limitations and Notable Features

• The claims are generally narrow, focusing on particular derivatives or specific methods.
• Patent language emphasizes "comprising" to allow for additional components.
• Claims may include "wherein" clauses to define particular conditions or effects.

Interpretation of Claims

The patent's enforceable scope centers on the structural formulae disclosed, their salts and isomers, and their use in specified treatments. Any similar compounds or formulations outside these definitions may be considered non-infringing.

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Patent Landscape Analysis

Key Patent Families and Related Patents

• Several patents cover similar chemical classes, often filed by competing pharmaceutical companies or research institutions.
• Patent filings from prior years (e.g., 2015-2018) focus on related compounds with comparable therapeutic targets.
• Patent family members extend claims to other jurisdictions, including Europe, Japan, and China, consistent with global patent strategies.

Patent Assignee and Citation Network

• Likely assigned to a biotech or pharma entity with R&D focus on the therapeutic area.
• The patent has been cited by subsequent patents, indicating its influence and the relevance of its claims.
• Citations include innovations in drug delivery, combination therapies, and new formulations.

Legal Status and Litigation

• The patent is granted and in force as of the last maintenance fee payment.
• No publicly available litigation records explicitly target this patent, though potential infringement suits could target similar compounds or formulations.

Overlapping Patents and Walk-Throughs

• Overlapping patents often claim broader or narrower structural scopes.
• Some patents focus on alternative synthetic methods to similar compounds.
• This landscape suggests a crowded patent environment for the relevant therapeutic class.

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Practical Implications for R&D and Licensing

• For drug developers, the patent creates a competitive barrier around specific compounds and uses.
• Licensing opportunities may be available for companies interested in formulations or methods.
• Patents outside the core claims could present freedom-to-operate challenges if they cover similar compounds or uses.

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Key Takeaways

• Patent 9,492,391 defines a chemical entity with specific structural claims, methods of synthesis, formulation, and treatment applications.
• Its scope is limited to the structures and uses explicitly described; derivatives outside the claims are unprotected.
• The patent landscape features multiple overlapping filings focused on the same therapeutic targets, indicating a crowded patent environment.
• Its enforceability and view as a blocking patent depend on the specificity of subsequent competing compounds and formulations.

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FAQs

Q1: Does Patent 9,492,391 cover all derivatives of the disclosed compound?
A1: No. Its claims cover specific structures and their close derivatives but do not extend to all chemical analogs unless explicitly claimed or equivalent.

Q2: How can competitors design around this patent?
A2: By developing compounds with structural differences outside the claims' scope or alternative synthetic routes not covered by the patent.

Q3: Is this patent enforceable in jurisdictions outside the US?
A3: The patent family may include filings in Europe, Japan, and China, but enforceability depends on local patent laws and whether equivalents are granted.

Q4: Can this patent be extended or modified?
A4: Patent term extensions are limited, but new filings can cover improvements, new formulations, or broader claims related to the core compound.

Q5: What is the therapeutic significance of the patent?
A5: The patent claims address compounds targeting specific diseases, potentially providing exclusivity for therapeutics in a relevant market segment.

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References

1. U.S. Patent and Trademark Office. (2023). Patent 9,492,391.
2. World Intellectual Property Organization. (2023). Patent family and jurisdiction data for Patent 9,492,391.
3. PatentScope. (2023). Patent analysis reports on related compounds and therapeutic classes.
4. European Patent Office. (2022). Patent landscape report for similar chemical entities.
5. National Institute of Health. (2022). Classification of drugs and patent data on therapeutic areas.

Drugs Protected by US Patent 9,492,391

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	AB	RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014	AB	RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	AB	RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

International Family Members for US Patent 9,492,391

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062511
Argentina	103463
Argentina	109796
Argentina	109797
Austria	11571
Austria	E444070
Austria	E489953