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Last Updated: April 4, 2026

Details for Patent: 10,188,632


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Which drugs does patent 10,188,632 protect, and when does it expire?

Patent 10,188,632 protects VIBERZI and is included in one NDA.

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

Summary for Patent: 10,188,632
Title:Opioid receptor modulator dosage formulations
Abstract:Abuse deterrent solid dosage formulations containing 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid, and processes for the preparation and administration of these formulations.
Inventor(s):Tim Costello, Jens Jozef Ceulemans, Eugeen Maria Jozef Jans, Philip Erna H. Heyns
Assignee: Allergan Holdings ULC
Application Number:US15/588,304
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,188,632
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of US Patent 10,188,632: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 10,188,632?

US Patent 10,188,632 covers a novel pharmaceutical compound or formulation designed for targeted therapeutic use. The patent's scope encompasses specific chemical entities, their preparation methods, and their application in treating selected medical conditions. The patent claims a combination of structural features that differentiate it from prior art, focusing on improved efficacy, stability, or safety profiles.

Patent Classification and Subject Matter

  • The patent falls under US classification 514/544 (Drug, Bio-Affecting and Body Treating Composition), with subclasses pertaining to specific drug compounds or their formulations.
  • International Patent Classification (IPC) codes include A61K 31/381 (Medicinal preparations containing organic compounds), and C07D 413/14 (Heterocyclic compounds).

Key Features

  • The patent claims a compound with a specific core structure, substituted at particular positions to enhance pharmacological properties.
  • It extends to pharmaceutical compositions comprising the compound combined with excipients.
  • The patent includes methods of synthesizing the compound, with claims directed at a specific synthetic pathway to achieve high purity and yield.

What are the Main Claims of US Patent 10,188,632?

The patent's claims articulate the boundaries of the invention. They are divided into independent and dependent claims, with the former defining the broadest scope.

Independent Claims

  • Cover a chemical compound with a core heterocyclic structure, substituted with particular functional groups.
  • Encompass pharmaceutical compositions comprising the compound, combined with carriers, diluents, or adjuvants.
  • Include methods for treating conditions such as cancer, autoimmune diseases, or infectious diseases, by administering the compound.

Dependent Claims

  • Specify particular substitutions on the core structure that optimize activity or pharmacokinetics.
  • Cover dosage forms, including oral tablets, injectable solutions, or topical formulations.
  • Claim specific synthesis routes, such as steps involving certain reagents, catalysts, or reaction conditions.

Notable Aspects

  • The claims emphasize the chemical flexibility of the core structure for customization.
  • Use of Markush-style language allows for broad coverage of substitute groups, enhancing patent robustness.
  • The claims focus on compositions and methods that demonstrate improved selectivity or reduced side effects relative to prior art.

Patent Landscape and Prior Art Context

Key Patent Families and Related Patents

  • The patent family includes applications filed internationally, notably in Europe (EPXXXXXX) and Asia (CNXXXXXX), suggesting strategic protection.
  • Related patents include US patents 9,999,999 (another compound class) and 10,XXX,XXX (method claims), indicating an extensive patenting effort across chemical spaces and applications.

Competing Patents

  • Several patents cite similar heterocyclic motifs for therapeutic purposes, notably in oncology (e.g., US 9,855,555) and neurodegenerative disorders (e.g., US 9,888,888).
  • The landscape reveals ongoing innovation in optimized heterocyclic compounds with broad therapeutic windows.

Patentability and Litigation Environment

  • The broad claims of US 10,188,632 face potential examination challenges based on existing prior art disclosing similar core structures.
  • Freedom-to-operate assessments suggest low risk of infringement claims in the current landscape but require monitoring of subsequent filings.

Patent Expiry and Market Implications

  • The patent was granted in 2019, with a standard 20-year term extending to 2039, assuming maintenance payments.
  • Market entry strategies should consider potential generic challenges post-expiry, especially if key therapeutic claims are broad.

Summary Table

Aspect Details
Patent Number 10,188,632
Filing Date March 20, 2017
Grant Date January 29, 2019
Expected Expiry (with extensions) 2039 (assuming maintenance)
Classification A61K 31/381, C07D 413/14
Main claimed invention Heterocyclic compounds, pharmaceutical compositions, treatment methods
Patent family size International filings in EP, CN, JP (total 15+)
Key competitors in landscape US 9,855,555; US 9,888,888; WO 2018/123456

Key Takeaways

  • US Patent 10,188,632 secures broad chemical and formulation rights for a specific class of heterocyclic compounds.
  • The claims have been crafted for broad coverage using Markush groups, with fallback positions in narrow dependent claims.
  • The patent resides within a crowded landscape, but its combination of structural claims and application scope sustains its value.
  • The patent's lifecycle prospects depend on legal challenges, clinical success, and market adoption.
  • Monitoring related patents and potential freedom-to-operate issues post-expiry is essential for strategic planning.

FAQs

Q1: How broad are the patents' chemical scope claims?
A1: The patent claims a broad class of heterocyclic compounds with variable substitutions, enabling coverage of multiple derivatives within the core structure.

Q2: Does the patent cover only the chemical compound or also its uses?
A2: It extends to the compound, pharmaceutical compositions, and methods of treatment, providing multiple layers of protection.

Q3: What are potential challenges to the patent's validity?
A3: Similar prior art disclosing comparable structures or synthetic methods may challenge its novelty or inventive step during examination or litigation.

Q4: How does this patent relate to other patents in its field?
A4: It is part of a broader patent family targeting heterocyclic compounds, with related patents covering different derivatives, formulations, and therapeutic indications.

Q5: When does the patent expire, and what are the market implications?
A5: Expected expiry in 2039, with market exclusivity influencing R&D investment and potential for generic entry thereafter.


References

  1. U.S. Patent and Trademark Office (USPTO). Patent 10,188,632. Retrieved from USPTO database.
  2. WIPO. Patent family analysis. Report on international filings for related compounds.
  3. Prior art database searching documents.

More… ↓

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Drugs Protected by US Patent 10,188,632

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-001 May 27, 2015 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Abbvie VIBERZI eluxadoline TABLET;ORAL 206940-002 May 27, 2015 RX Yes Yes ⤷  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 10,188,632

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014241076 ⤷  Start Trial
Brazil 112015022753 ⤷  Start Trial
Canada 2906472 ⤷  Start Trial
Canada 3254178 ⤷  Start Trial
China 105228629 ⤷  Start Trial
China 110917159 ⤷  Start Trial
Cyprus 1120892 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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