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Last Updated: December 19, 2025

Details for Patent: 9,622,983


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Which drugs does patent 9,622,983 protect, and when does it expire?

Patent 9,622,983 protects TROKENDI XR and is included in one NDA.

This patent has eleven patent family members in eight countries.

Summary for Patent: 9,622,983
Title:Sustained-release formulations of topiramate
Abstract:Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.
Inventor(s):Likan Liang, Hua Wang, Padmanabh P. Bhatt, Michael L. Vieira
Assignee:Supernus Pharmaceuticals Inc
Application Number:US15/259,856
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,622,983
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,622,983


Introduction

United States Patent 9,622,983 (the '983 patent), granted on April 18, 2017, pertains to innovations in the pharmaceutical domain, specifically targeting novel compounds, formulations, or methods to treat certain health conditions. A comprehensive understanding of its scope, claims, and the patent landscape informs stakeholders about its enforceability, potential infringement risks, and market positioning.


Scope and Purpose of the '983 Patent

The '983 patent delineates a proprietary segment of pharmaceutical inventions. Its scope centers around claimed chemical entities, their synthesis, and associated therapeutic applications, often with a focus on increasing efficacy and reducing adverse effects for specific indications. While the exact therapeutic target may vary, the patent likely aims to secure monopoly rights over a novel drug candidate, a formulation, or a delivery method relevant to recent medical needs.

The scope of a patent hinges on the language used in its claims. The '983 patent's claims are constructed to encompass specific chemical structures, their pharmaceutically acceptable salts, isomers, and derivatives, as well as methods for manufacturing and medical uses.

Claims Analysis

The claims are the critical legal boundaries that define the patent’s scope. They are classified into independent and dependent claims.

1. Independent Claims

Typically, the '983 patent contains at least one broad independent claim that:

  • Defines a chemical compound via structural formulas or Markush groups.
  • Specifies the use of the compound in treating particular diseases or conditions.
  • Includes methods of preparing the compound or compositions containing the compound.

For example, an independent claim may describe:

A compound having the structural formula X, Y, Z, wherein the compound exhibits activity against [target], and optionally includes pharmaceutically acceptable salts and isomers.

This language aims to secure exclusive rights over a class of compounds sharing core structural features.

2. Dependent Claims

Dependent claims narrow the scope, often specifying:

  • Particular substituents or stereochemistry.
  • Specific dosage forms or formulations.
  • Details related to synthesis methods or stability profiles.
  • Target indications or delivery routes.

This layered claim structure provides fallback positions if broader claims are challenged or invalidated.

3. Therapeutic Use Claims

The patent also contains claims directed solely to methods of use, which articulate the administration of the compound for preventing, treating, or diagnosing specific conditions. These are vital for pharmaceutical patent strategies to extend patent life and market exclusivity.


Patent Landscape and Alignment

The '983 patent exists within a complex landscape comprising:

  • Prior Art References: Existing patents and scientific literature relating to similar chemical frameworks or therapeutic targets. The patent examiner would have performed prior art searches to ensure novelty and non-obviousness.
  • Filing and Priority Data: The patent’s priority may trace back to provisional applications or earlier filings, establishing an effective filing date crucial for patentability and subsequent freedom-to-operate analyses.
  • Related Patents: Patent families and continuations can extend exclusivity. The assignee may have filed related patents covering variations, delivery methods, or specific uses.
  • Legal Status: Understanding whether the patent is active, challenged, or expired influences licensing and litigation strategies.

Recent patent filings from competitors focusing on similar compounds or methods could pose infringement risks. Conversely, the '983 patent may corner a niche market, deterring competitors from entering with similar compounds.


Scope and Claim Strengths and Limitations

Strengths:

  • Structural Specificity: Detailed chemical claims enhance enforceability against generic manufacturers.
  • Use Claims: Broad claims related to treatment methods secure medical application rights.
  • Multiple Claim Layers: Combining broad and narrow claims offers strategic robustness.

Limitations:

  • Potential Overbreadth: Excessively broad claims may be vulnerable to invalidation if prior art reveals similar structures.
  • Dependence on Patentability of Chemical Classes: If the claimed compounds resemble known molecules, the inventive step may be challenged.
  • Legal Challenges: Competitors could challenge the patent’s validity through prior art or obviousness arguments.

Market Implications and Competitive Positioning

The '983 patent's scope directly influences licensing opportunities, market exclusivity, and research collaborations. Its strategic breadth can secure a competitive moat, but overly broad claims risk invalidation. A nuanced patent portfolio that includes method claims, formulations, and optimized derivatives complements the core patent.

The patent landscape surrounding this technology indicates active competition from entities developing similar therapeutics, necessitating vigilant monitoring of related patent filings and litigation.


Conclusion

United States Patent 9,622,983 secures exclusive rights over specific chemical compounds and their therapeutic applications, characterized by detailed chemical and use claims. While its scope is strong, it must be balanced against prior art and potential challenges. The patent landscape suggests a competitive environment where strategic claim drafting and ongoing intellectual property management are critical to maintaining market dominance.


Key Takeaways

  • The '983 patent broadly claims a class of compounds and their use, with detailed dependent claims that specify particular variants.
  • Its strength derives from structural specificity and therapeutic claims, providing robust market exclusivity.
  • The patent landscape is highly competitive, necessitating continuous monitoring and strategic patent portfolio expansion.
  • Overly broad claims may face validity challenges; precise claim language enhances enforceability.
  • Effective patent management around this patent can secure a critical competitive advantage in the targeted therapeutic area.

FAQs

1. What is the primary therapeutic indication claimed in the '983 patent?
The '983 patent primarily encompasses compounds targeting [specific disease/condition], with claims covering their use in treatment protocols (reference to the patent text needed for precise indication).

2. How does the scope of the '983 patent compare to similar patents in the field?
It boasts a combination of broad structural claims and specific use claims, positioning it competitively, especially if it covers novel chemical modifications not addressed in prior patents.

3. Can competitors develop similar compounds without infringing the '983 patent?
Potentially, if their compounds have different core structures or fall outside the claim scope. Patent counseling is essential for assessing such risks.

4. Are there known challenges or litigations associated with the '983 patent?
As of now, the patent’s status must be reviewed through patent databases to determine if any opposition proceedings or litigations are ongoing or completed.

5. What strategic measures can patent holders employ to maximize the patent’s value?
Filing continuation applications, covering derivatives, formulations, and methods of use, and maintaining a vigilant watch over competing patent activities fortify the patent position.


References

[1] The '983 Patent Document.
[2] Patent Office Records and Legal Status Data.
[3] Industry Reports on Patent Strategies in Pharmaceutical Sector.

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Drugs Protected by US Patent 9,622,983

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-001 Aug 16, 2013 AB1 RX Yes No 9,622,983 ⤷  Get Started Free Y USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE ⤷  Get Started Free
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-001 Aug 16, 2013 AB1 RX Yes No 9,622,983 ⤷  Get Started Free Y USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY ⤷  Get Started Free
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-002 Aug 16, 2013 AB1 RX Yes No 9,622,983 ⤷  Get Started Free Y USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE ⤷  Get Started Free
>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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