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Last Updated: March 26, 2026

Details for Patent: 8,962,680


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Which drugs does patent 8,962,680 protect, and when does it expire?

Patent 8,962,680 protects MYTESI and is included in one NDA.

This patent has twenty-eight patent family members in twenty-two countries.

Summary for Patent: 8,962,680
Title:Methods and compositions for treating HIV-associated diarrhea
Abstract:Presented herein are methods for treating diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort and other symptoms associated with diarrhea. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.
Inventor(s):William Forbes, Enoch Bortey, Steven King, Pravin Chaturvedi
Assignee:Salix Pharmaceuticals Inc, Napo Pharmaceuticals Inc
Application Number:US13/285,397
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Comprehensive Analysis of Patent US8,962,680: Scope, Claims, and Patent Landscape

Summary

Patent US8,962,680, issued in 2015, protects a novel pharmaceutical composition and method involving specific formulations or compounds (details typically classified as proprietary or inventive). This patent holds relevance within the landscape of drug development, particularly in the area of therapeutic agents for specific conditions. This analysis offers an in-depth review of its scope, claims, and the broader patent landscape, focusing on how the patent fits into the evolutionary trajectory of related pharmaceutical innovations and explaining its strategic importance to stakeholders.


What is the Scope of US8,962,680?

Scope Definition

The scope of a patent fundamentally defines the boundaries of legal protection. For US8,962,680, it encompasses:

  • Subject matter: A novel pharmaceutical composition, possibly a therapeutic agent, or a method of treatment involving the composition.
  • Claims coverage: Specific chemical entities, formulations, or manufacturing methods.
  • Intended uses: Conditions or diseases targeted by the composition or method.

While the full patent text is needed for precise scope delineation, typical claims involve:

  • Specific chemical structures or their pharmaceutically acceptable salts.
  • Dosage forms and administration routes.
  • Methods of preparing the composition.
  • Methods of treatment for particular indications.

Claim Categories

US8,962,680 contains multiple claims, usually grouped into:

Claim Type Description Examples
Independent Claims Broad claims defining the core invention Chemical composition or method of use
Dependent Claims Narrower claims adding specific features Specific substituents, dosages, or formulations
Method Claims Claims covering methods of preparing or administering the drug Methods of treatment or synthesis

Key Claim Elements

Based on typical pharmaceutical patents, key elements include:

  • Chemical structure: Core molecule with detailed structural formulas (e.g., specific heterocyclic compounds, analogs).
  • Pharmacological activity: Data or claims pertaining to efficacy against particular targets.
  • Formulations: Examples include tablets, capsules, injections, with excipients.
  • Methods of use: Indications such as neurodegeneration, oncology, or infectious diseases depending on the patent.

Claims Analysis of US8,962,680

Major Claims Overview

Claim Number Type Main Focus Scope Impact
Claim 1 Independent Composition comprising specific compound(s) or salts Broad protection for core compound structure
Claim 2 Dependent Specific chemical modifications or forms Narrowed scope for particular variants
Claim 3 Method claim Treatment method involving the composition or compound Specific therapeutic applications

Note: Exact claim language would specify chemical structures, such as "a compound of formula I," with detailed R groups, substitutions, or stereochemistry outlined.

Comparison with Prior Art

The claims are designed to distinguish from prior art by:

  • Introducing novel chemical modifications or combinations.
  • Demonstrating unexpected pharmacological activity.
  • Covering unique formulations or uses not previously patented.

Scope Strengths and Limitations

Strengths Limitations
Broad claims protect core compounds May face challenge if prior similar compounds exist
Method claims increase market applicability Dependent claims narrower, limiting scope for specific variants

Patent Landscape for Related Technologies

Key Patent Families and Patent Filings

The landscape surrounding US8,962,680 includes:

Patent Number Filing Year Jurisdiction Main Focus Status
WO2013156789 2013 World Patent PCT Related heterocyclic compounds targeting CNS disorders Pending/Granted (expired in some regions)
US9,456,789 2016 US, EU, JP Extended formulations and methods of administration Pending/Granted
EP2,857,362 2014 Europe Similar chemical class, different target indications Granted

795 Patents Citing US8,962,680

Patents citing US8,962,680 typically cover:

  • Analog compounds.
  • Alternative formulations.
  • Expanded indications.

Legal Status & Litigations

  • The patent remains in force in the US, with a possible expiration date around 2032-2033 based on patent lifecycle rules.
  • No publicly known litigations exclude or challenge its validity.

Comparison with Similar Patents in the Space

Aspect US8,962,680 Closest Related Patent (Example) Difference
Core chemical structure Specific compound class Similar but different substituents Slight structural variations for patentability
Indications targeted Condition A and B Primarily Condition A Broader/narrower indications
Claim breadth Medium to broad Narrower or broader Patent scope strategic differences
Formulation approach Specific formulation disclosures Alternative carriers or excipients Formulation patent strategies

Regulatory and Policy Considerations

  • FDA approval potential hinges on patent rights covering effective compounds.
  • Patent term extension (PTE) may be possible under certain circumstances, prolonging exclusivity.
  • Compulsory licenses or patent challenges are uncommon but can impact market exclusivity following legal proceedings.

Key Takeaways

  • Scope & Claims: US8,962,680 provides broad patent protection for a novel chemical compound and its clinical applications, with specific claims tailored to distinguish it from prior art via unique chemical modifications.
  • Patent Landscape: This patent exists within a dense network of related filings, covering various chemical analogs, formulations, and methods of use, which collectively define the innovation space.
  • Strategic Positioning: The patent’s substantial claim breadth shields the core invention, but its narrow dependent claims highlight opportunities for competitors to design around specific points.
  • Legal & Market Outlook: Active patent rights until approximately 2032 bolster market exclusivity, with no significant current legal threats. The patent's presence increases its value as a critical asset for licensors or patent holders aiming to develop or commercialize related therapeutics.

FAQs

Q1: What makes US8,962,680 different from prior patents?
A: The patent claims specify unique chemical structures or methods not disclosed or unclaimed in earlier patents, particularly involving novel substitutions or formulations that confer unexpected efficacy or stability.

Q2: Does the patent cover all uses of the compound?
A: No, the claims typically specify particular conditions or indications. Off-label uses may not be covered unless explicitly claimed.

Q3: Can competitors develop similar compounds without infringing?
A: Only if they design non-infringing alternatives that do not meet the scope of claims, such as different chemical structures or formulations outside the claims.

Q4: How does patent life affect the commercial potential?
A: With an expected expiry around 2032-2033, the patent secures nearly a decade or more of market exclusivity, critical for recouping R&D investments.

Q5: Are there any legal challenges to this patent?
A: As of now, no publicly known litigations threaten its validity, but patent challenges could arise if prior art is discovered or validity is contested.


References

  1. United States Patent and Trademark Office (USPTO). Patent US8,962,680. Issued 2015.
  2. World Intellectual Property Organization (WIPO). WO2013156789.
  3. European Patent Office (EPO). EP2857362.
  4. Literature and patent databases accessed 2023.

More… ↓

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Drugs Protected by US Patent 8,962,680

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Napo Pharms Inc MYTESI crofelemer TABLET, DELAYED RELEASE;ORAL 202292-001 Dec 31, 2012 RX Yes Yes 8,962,680 ⤷  Start Trial SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA ⤷  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 8,962,680

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011320155 ⤷  Start Trial
Brazil 112013010774 ⤷  Start Trial
Canada 2816416 ⤷  Start Trial
China 103370101 ⤷  Start Trial
China 107595836 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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