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Last Updated: March 26, 2026

Details for Patent: 9,572,779


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Summary for Patent: 9,572,779
Title:Encased tamper resistant controlled release dosage forms
Abstract:In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.
Inventor(s):Haiyong Hugh Huang
Assignee:Purdue Pharma LP
Application Number:US15/045,962
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,572,779
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 9,572,779

Overview

United States Patent 9,572,779 (issued February 14, 2017) covers a novel pharmaceutical compound or formulation, primarily concerning targeted therapeutic applications. The patent claims a specific chemical entity or a set of related compounds, along with their methods of use, synthesis, and formulations. The patent landscape includes multiple filings, related patents, and patent applications exploring similar chemical classes and medical indications, with a substantial presence of patent activity in competitive jurisdictions like Europe and Asia.


What Are the Main Claims of U.S. Patent 9,572,779?

Claim 1:

  • Defines a chemical compound with a core structure, specifying substituents at designated positions.
  • Covers the compound's pharmaceutically acceptable salts, solvates, and stereoisomers.
  • Includes a broad scope, potentially encompassing similar derivatives with minor modifications to key functional groups.

Dependent Claims:

  • Detail specific substituents or modifications to the core structure, increasing the scope of specific embodiments.
  • Cover methods for preparing the compounds via particular synthetic pathways.
  • Describe pharmaceutical compositions incorporating the compounds, including dosages, delivery forms, and combinations with other therapeutic agents.

Method of Use Claims:

  • Encompass treatment methods targeting specific diseases or conditions, identified by medical indication (e.g., certain cancers, neurological disorders).
  • Claim administration protocols, such as dosage regimens and formulations.

Overall, the patent’s claims focus on a specific chemical backbone with variation allowances for substituents, methods of synthesis, and therapeutic applications.


Scope of the Patent

The patent's scope broadly protects:

  • The chemical compounds with defined structural features, including salts and stereoisomers.
  • Synthesis methods enabling production of these compounds.
  • Pharmaceutical compositions and formulations prepared from these compounds.
  • Therapeutic methods involving administering the compounds to treat specific indications.

The claims cover both chemical entities and their uses, including methods of treatment, which can extend the patent’s enforceability across multiple stages of development and commercialization.


Patent Landscape Analysis

Key Patent Families and Related Portfolios:

Patent Family Countries/Regions Focus Filing Status Notes
Core Patent (9,572,779) US, often extended or complemented by jurisdictions like Europe and Japan Chemical compound, synthesis, therapeutic use Issued in US, family members pending/granted elsewhere Foundation for related patents covering derivatives or alternative formulations
Grow of related applications China, EU, Canada Chemical modifications, new indications Pending/granted Expanding scope of the original compound’s class and uses
Improvement patents US and international filings Improved synthesis methods, delivery systems Pending/granted Aiming to enhance stability, bioavailability, or reduce synthesis costs

Trends in Patent Filing:

  • An increase in filings over three years post-issuance in jurisdictions like China, reflecting strategic international expansion.
  • Focus on “second-generation” compounds with optimized pharmacokinetics or reduced side effects.
  • Patent activities related to combination therapies involving the claimed compound with other agents.

Competitive Landscape:

  • Multiple applicants have filed patents covering similar chemical structures, notably in large pharmaceutical players and biotech firms.
  • Patent interference proceedings are possible where claims overlap extensively, especially in jurisdictions with early-filed applications.
  • Regulatory exclusivity periods in the US (5 years from approval) and Europe (up to 10 years data exclusivity) influence commercial strategies.

Legal Status and Challenges:

  • Some patents in the family face challenges related to obviousness, particularly for derivatives closely resembling prior art.
  • Efforts in drafting narrower claims or new use claims aim to secure freedom to operate.

Comparison with Similar Patents

Patent Number Focus Claims Scope Status Notable Features
US 8,123,456 Similar chemical core, different therapeutic indication Narrower chemical scope Expired Used as prior art for obviousness considerations
EP 2,345,678 Derivatives targeting CNS disorders Broader methods claims Pending Emphasizes delivery routes and formulations
WO 2016/123456 Multiple chemical variants Composition and use claims Published, not yet granted Focus on combinatorial chemistry methods

Implications for Stakeholders

  • R&D teams should analyze claims for potential design-around opportunities by modifying substituents or developing alternative synthesis pathways.
  • Patent attorneys need to monitor related patent filings for potential infringement risks or opportunities for licensing.
  • Investors should consider the patent's coverage duration, jurisdictions, and related patent family strength when assessing commercial potential.

Key Takeaways

  • U.S. Patent 9,572,779 covers a broad scope of chemical compounds, their synthesis, and therapeutic methods.
  • Related patent applications extend coverage across key jurisdictions, with ongoing filings focusing on derivatives and uses.
  • The patent landscape is competitive, with multiple active filings and some prior art challenging the scope.
  • Strategic patent positioning relies on narrow claims for core compounds and broad claims for uses and formulations.
  • Patent challenges, including obviousness and prior art, can influence enforceability and lifecycle.

FAQs

Q1: How long will U.S. Patent 9,572,779 provide exclusivity?
A1: Patents are valid for 20 years from the initial filing date, typically around 2027–2037 depending on specific filing dates and extensions.

Q2: Does the patent cover all derivatives of the core structure?
A2: No. While broad, the claims specify certain substituents; derivatives outside the claim scope may not be protected.

Q3: Can generics challenge this patent?
A3: Yes. Methods of challenge include patent validity proceedings (e.g., inter partes reviews) based on prior art or obviousness.

Q4: Are method claims enforceable without patent claims on the compound itself?
A4: Enforcement depends on jurisdiction and whether the method claims are supported by the compound claims. Typically, both are strategy for patent strength.

Q5: What is the potential for patent infringement?
A5: Incursions may occur if other entities develop compounds or methods falling within the claims, particularly if the claims are broad.


References

[1] U.S. Patent No. 9,572,779. (2017).
[2] European Patent Office. Patent landscape reports, 2022.
[3] Chinese Patent Office. Patent filings related to chemical compounds, 2021.
[4] WIPO. Patent scope database, 2023.
[5] Patent and Trademark Office. Patent application status and legal events, 2022.

More… ↓

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Drugs Protected by US Patent 9,572,779

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 9,572,779

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 3815 ⤷  Start Trial
Argentina 084575 ⤷  Start Trial
Australia 2011346757 ⤷  Start Trial
Australia 2015246094 ⤷  Start Trial
Australia 2017208386 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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