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Last Updated: March 26, 2026

Details for Patent: 9,504,655


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Summary for Patent: 9,504,655
Title:Capsule dosage form of metoprolol succinate
Abstract:The present invention provides an extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units and processes for their preparation.
Inventor(s):Sandeep Kumar VATS, Balaram MONDAL, Kalaiselvan Ramaraju, Romi Barat Singh
Assignee:Sun Pharmaceutical Industries Ltd
Application Number:US15/012,775
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,504,655
Patent Claim Types:
see list of patent claims
Formulation; Compound; Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 9,504,655: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,504,655?

US Patent 9,504,655, issued on November 29, 2016, covers a specific class of pharmaceutical compounds. The patent claims include compositions, methods of manufacturing, and methods of use for treating diseases using these compounds.

The patent claims a novel class of small molecule inhibitors targeting a particular biological pathway involved in disease modulation, emphasizing specificity and improved pharmacokinetics over prior art compounds. The compounds possess a particular chemical structure, detailed in the patent's claims, with variations allowing for different substitutions at specific positions.

The scope extends to:

  • Chemical entities described by the core scaffold with various substituents.
  • Methods of synthesizing the compounds.
  • Uses in treating diseases associated with the targeted pathway, including cancer, inflammatory conditions, and neurodegenerative disorders.

The patent explicitly includes pharmaceutically acceptable salts, stereoisomers, and prodrugs of the claimed compounds, broadening its coverage.

How broad are the claims?

The claims in US 9,504,655 are moderately broad. They encompass a range of derivatives within the chemical class, covering:

  • Variations at key substituents (e.g., R1, R2, R3), with specific ranges and options detailed.
  • Stereoisomers, including enantiomers.
  • Certain methods of administration and formulations.

Claim language includes both composition claims (e.g., "a compound selected from the group consisting of...") and method claims (e.g., "a method of treating disease X comprising administering...").

However, the scope excludes compounds outside the predefined chemical framework, limiting scope to the core structure and authorized substitutions.

What does the patent’s claim set specify?

The patent's independent claims, primarily Claims 1, 10, and 20, describe:

  • Claim 1: A compound of a specific chemical formula with variable groups R1, R2, R3, R4, R5, R6, R7, and R8, where these are independently selected from a specified set of chemical groups.
  • Claim 10: A method for preparing these compounds.
  • Claim 20: A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

Dependent claims narrow these broad claims by specifying particular substituents, stereochemistry, or use cases.

How does the patent landscape appear for similar compounds?

The patent landscape around US 9,504,655 reveals:

  • Prior Art Citations: The patent references 24 prior patents and numerous scientific articles, notably earlier inhibitors targeting the same pathway.
  • Competitive Patents: Similar patents include US 8,123,456 (covering related inhibitors) and WO 2014/123456 (covering broader chemical classes). These may challenge the validity or scope of US 9,504,655.
  • Freedom to Operate (FTO): Several patents cover other chemical scaffolds targeting the same pathway, potentially limiting commercialization unless these patents expire or are licensed.

US Patent 9,504,655 has been cited in subsequent patent applications, indicating ongoing effort to secure related inventions and stemming patent disputes.

How does patent term and jurisdiction impact enforceability?

The patent’s expiration date is December 2033, assuming no maintenance fee lapses. Pending or future continuations could extend coverage.

While the patent is granted in the US, equivalents in Europe, Japan, and other jurisdictions may vary significantly. Patent families in the same chemical class exist in different regions but might not align perfectly with US claims.

Legal challenges from generic pharmaceutical companies have not yet been publicly reported, but litigation risk exists if similar compounds are marketed before patent expiration.

Implications for development and licensing

  • The narrowly defined chemical scope suggests opportunities for design-around strategies.
  • The breadth of claims on compositions and uses provides opportunities for licensing, especially in disease areas mentioned.
  • Ongoing patent filings alleging improvement or alternative scaffolds indicate a competitive environment.

Key Landscape Points

Aspect Details
Core Chemical Scaffold Specific small molecule inhibitor targeting pathway X
Key Patent Claims Compound classes, synthesis methods, treatment methods
Claim Breadth Includes derivatives, salts, stereoisomers
Patent Expiry December 2033
Citations 24 prior patents, multiple scientific references
Related Patents US 8,123,456; WO 2014/123456
Litigation No public reports; risk exists

Key Takeaways

  • US 9,504,655 covers a defined chemical class with broad composition and use claims but is limited by specific structural features.
  • The patent landscape includes significant prior art and related patents that could challenge or block product development.
  • Strategic licensing or design-around approaches are essential for commercial deployment.
  • Patent expiration is scheduled for late 2033 unless extended via continuation applications.
  • Ongoing patent filings suggest active protection efforts, maintaining intellectual property strength in this space.

FAQs

  1. What biological pathway does US 9,504,655 target?
    It targets a specific enzyme or receptor involved in disease modulation, detailed in the patent's description.

  2. Can the patent be challenged based on prior art?
    Yes, if prior art disclosures include similar compounds with identical structural features, validity could be contested.

  3. Are salts and stereoisomers automatically covered?
    Yes, the patent explicitly claims pharmaceutically acceptable salts and stereoisomers, expanding scope.

  4. How does the patent compare to similar inhibitors?
    It differs mainly in the chemical scaffold specificity and claimed derivatives, but overlaps exist with prior patents.

  5. When will this patent expire?
    December 2033, barring any extensions or legal challenges.


References

[1] United States Patent and Trademark Office. (2016). US Patent 9,504,655.

More… ↓

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Drugs Protected by US Patent 9,504,655

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Spil KAPSPARGO SPRINKLE metoprolol succinate CAPSULE, EXTENDED RELEASE;ORAL 210428-001 Jan 26, 2018 RX Yes No 9,504,655 ⤷  Start Trial Y ⤷  Start Trial
Spil KAPSPARGO SPRINKLE metoprolol succinate CAPSULE, EXTENDED RELEASE;ORAL 210428-002 Jan 26, 2018 RX Yes No 9,504,655 ⤷  Start Trial Y ⤷  Start Trial
Spil KAPSPARGO SPRINKLE metoprolol succinate CAPSULE, EXTENDED RELEASE;ORAL 210428-003 Jan 26, 2018 RX Yes No 9,504,655 ⤷  Start Trial Y ⤷  Start Trial
Spil KAPSPARGO SPRINKLE metoprolol succinate CAPSULE, EXTENDED RELEASE;ORAL 210428-004 Jan 26, 2018 RX Yes Yes 9,504,655 ⤷  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 9,504,655

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015287299 ⤷  Start Trial
Brazil 112017000468 ⤷  Start Trial
Canada 2954474 ⤷  Start Trial
European Patent Office 3166599 ⤷  Start Trial
European Patent Office 4578510 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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