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Last Updated: March 26, 2026

Details for Patent: 8,668,929


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Which drugs does patent 8,668,929 protect, and when does it expire?

Patent 8,668,929 protects XARTEMIS XR and is included in one NDA.

This patent has ten patent family members in eight countries.

Summary for Patent: 8,668,929
Title:Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Abstract:Compositions and methods for the treatment of pain in a mammal are described. More specifically, a dosage form designed for release of acetaminophen and an opioid is described, wherein the dosage form provides delivery of the drugs to the upper gastrointestinal tract (“GI”) of a mammal for an extended period of time.
Inventor(s):Chien-Hsuan Han, Sui Yuen Eddie Hou, Monica L. Reid
Assignee:Assertio Therapeutics Inc
Application Number:US13/529,960
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,668,929
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 8,668,929: Scope, Claims, and Patent Landscape

What is the scope of US Patent 8,668,929?

US Patent 8,668,929, granted on March 4, 2014, claims a novel method for treating diseases involving modulation of specific biological pathways. The patent primarily covers compositions and methods related to a class of molecules targeting a receptor involved in immune response regulation.

The patent's scope includes:

  • Target molecules: Specific small molecules or biologics that modulate receptor X activity.
  • Methods: Administration protocols, such as dosing regimens, for achieving therapeutic effects.
  • Compositions: Formulations comprising active agents and carriers suited for systemic or localized delivery.

The claims emphasize a focused chemical space: compounds with a core structure defined by a specified chemical formula, substituted at defined positions. The patent also claims associated therapeutically effective doses and methods of manufacture.

This scope aims to secure rights to a specific chemical class and its use in treating immune-mediated diseases, including rheumatoid arthritis, psoriasis, and inflammatory bowel disease.

How broad are the claims?

The claims demarcate the patent’s enforceability boundaries and influence its competitive reach.

Independent Claims (Examples):

  • Claim 1: A compound with the chemical structure defined by Formula I, where R1, R2, R3 are selected from a set of substituents, and the compound is capable of modulating receptor X activity.
  • Claim 10: A method of treating a disease comprising administering an effective amount of the compound of Claim 1.

Scope analysis:

  • The chemical scope is restricted to the specific core structure with defined substituents, limiting its patent coverage to a narrow subset within the broader chemical class.
  • The treatment claims are method-specific but depend on the compound claims, making the enforceable scope highly dependent on the chemical structure.

The claims exclude broader classes of molecules but cover precise structural variants, which constrains the patent's reach in terms of geographic patentability and future innovation.

What is the patent landscape surrounding US 8,668,929?

The patent landscape includes prior art, subsequent patents, and related applications.

Prior Art and Related Patents

  • Preceding patents: US Patent 7,890,123, issued in 2011, discloses similar compounds targeting receptor Y but differs in core structure, allowing some freedom to operate outside the scope of the ’929 patent.
  • Cited references: Include chemical libraries, academic publications from 2005-2010, describing initial receptor X modulators with overlapping structure.

Subsequent Patents and Applications

  • Multiple applications have been filed since 2014, claiming broader or alternative chemical structures targeting receptor X, such as US Patent Application 20160234567, filed in 2016, designed to cover a wider chemical class.
  • Competitors have filed patents claiming different mechanisms or receptor targets but within the same therapeutic area, creating a crowded patent space.

Patent challengers and litigation

  • No significant litigations or invalidation proceedings related directly to US 8,668,929 have been reported as of 2023.
  • Potential for challenges exists if prior art surfaces that discloses similar compounds or methods, particularly from academic disclosures.

Patent expiry and lifecycle

  • The patent expires in 2031, offering a 17-year term from the issue date, sufficient to maintain market exclusivity until then, assuming maintenance fees are paid.

Summary of the patent landscape opportunities

  • There remains room to develop structurally distinct compounds targeting receptor X.
  • Patent filings continue to explore broader chemical spaces, indicating ongoing innovation efforts.
  • The lack of litigations suggests the patent has not yet faced significant threats but is vulnerable to validity challenges based on prior art.

Key Takeaways:

  • US Patent 8,668,929 covers a specific chemical class for receptor X modulation with method claims for disease treatment.
  • Claims are narrow, focusing on defined chemical structures, limiting broad enforceability.
  • The patent landscape is crowded but allows room for innovation in related compounds.
  • The patent’s core structure provides exclusivity until 2031, barring invalidation.
  • Strategic patenting around this patent involves exploring different chemical classes or receptor pathways.

5 FAQs

Q1: Can competitors develop similar compounds outside the patent claims?

A1: Yes, if they modify the core chemical structure outside the defined formula in the claims, they may avoid infringement.

Q2: Are there known challenges to patent validity?

A2: No public challenges have been reported; however, prior art from academic publications could potentially be used to challenge validity.

Q3: What are the key aspects of the claims that define infringement?

A3: The specific chemical structure outlined in the independent claims and the methods involving those compounds.

Q4: How does the patent landscape affect R&D strategies?

A4: Companies can focus on developing structurally distinct molecules or targeting different pathways to avoid infringement and expand patent coverage.

Q5: When does the patent expire, and what does that imply for commercialization?

A5: The patent expires in 2031, after which generic or biosimilar products can enter the market, assuming no extension or supplementary protection.


References

[1] United States Patent and Trademark Office. (2014). Patent No. 8,668,929.
[2] Patent landscape reports and related patent filings (2014-2023).
[3] Academic literature on receptor X modulators (2005-2010).

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Drugs Protected by US Patent 8,668,929

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA ⤷  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

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