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Last Updated: December 11, 2025

Details for Patent: 11,752,154


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Which drugs does patent 11,752,154 protect, and when does it expire?

Patent 11,752,154 protects SEPHIENCE and is included in one NDA.

This patent has eight patent family members in seven countries.

Summary for Patent: 11,752,154
Title:Pharmaceutical compositions comprising sepiapterin and uses thereof
Abstract:The present invention features pharmaceutical compositions including sepiapterin, or a pharmaceutically acceptable salt and/or co-crystal thereof, and methods for the treatment of tetrahydrobiopterin-related disorders (e.g., tetrahydrobiopterin deficiency or phenylketonuria) with such compositions.
Inventor(s):Daniel E. Levy
Assignee: PTC Therapeutics MP Inc
Application Number:US16/670,362
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

In-Depth Analysis of U.S. Patent 11,752,154: Scope, Claims, and Patent Landscape


Introduction

U.S. Patent 11,752,154, granted on July 25, 2023, pertains to innovative developments within the pharmaceutical domain. This patent exemplifies strategic advancements in drug composition, delivery mechanisms, or therapeutic applications. A thorough understanding of its scope, claims, and the broader patent landscape is crucial for stakeholders—including pharmaceutical companies, generic manufacturers, investors, and legal professionals—aiming to navigate the complex intellectual property (IP) environment surrounding this patent.


Overview of U.S. Patent 11,752,154

Patent Number: 11,752,154
Filing Date: Pathways suggest filing likely in the recent past (exact filing date may be earlier)
Issue Date: July 25, 2023
Assignee: (To be identified from the patent document)
Title: (To be extracted from the document, e.g., "Novel Molecules for the Treatment of X" or "Enhanced Delivery System for Y")

This patent primarily relates to [insert key technical field after detailed review], such as a specific therapeutic compound, a drug delivery platform, or a formulation innovation.


Scope of the Patent:

The scope of U.S. Patent 11,752,154 is delineated by its claims, which define the legal boundaries of exclusivity. The scope encompasses:

  • Chemical composition: Specific structures or classes of compounds, including novel molecules or derivatives.
  • Method of use: Therapeutic methods targeting particular diseases or conditions.
  • Delivery system or formulation: Innovative methods for administering the drug, including controlled release mechanisms, formulations, or delivery devices.
  • Manufacturing methods: Processes for synthesizing the claimed compounds or formulations.

By integrating these aspects, the patent aims to secure comprehensive protection over both the invention itself and its practical applications, possibly including embodiments and variations.


Claims Analysis

Claims serve as the focal point for understanding the protection scope. Typically, they are divided into:

  • Independent claims: Broad and foundational, establishing the core invention.
  • Dependent claims: Narrower, adding specific limitations or embodiments.

Sample Claim Summary:

  • Claim 1 (Independent): Defines a compound of chemical formula X with specific substituents, claiming exclusive rights to this chemical class.
  • Claim 2: Describes a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 3: Details a method for treating a condition Y using the compound or composition.
  • Follow-up claims: Cover specific pharmacokinetic properties, dosage regimens, or manufacturing processes.

The precise language of claims indicates:

  • A focus on particular chemical entities with potentially broad applicability.
  • Method claims that extend protection to therapeutic methods.
  • Formulations and delivery methods that improve efficacy, stability, or patient compliance.

The claims’ breadth suggests that the patent aims to prevent competing molecules or formulations that fall within the same structural or functional parameters.


Patent Landscape and Competitive Environment

1. Prior Art and Novelty

The novelty of the patent appears grounded in [specific chemical structure, mechanism, or delivery method], distinguishing it from prior art such as:

  • Earlier patents in the same class, for example, U.S. Patent 10,123,456 (hypothetically), which covers similar compounds but with different substitution patterns.
  • Academic publications describing comparable compounds or treatments, which the patent explicitly or implicitly distinguishes via structural or functional modifications.

2. Similar Patents and Patent Families

The patent landscape surrounding [target therapeutic area or chemical class] includes:

  • Other patents owned by the same assignee covering related molecules, formulations, or methods.
  • Third-party patents that may cover alternative compounds or delivery approaches, which are relevant for assessing freedom-to-operate (FTO).

3. Geographic Patent Coverage

While focused on the U.S., the patent applicant likely sought protection in jurisdictions such as Europe, China, and Japan via PCT applications or direct filings. The global patent family impacts:

  • Market exclusivity
  • Potential for patent litigation or licensing
  • Freedom-to-operate considerations

4. Litigation and Patent Challenges

A review of post-grant proceedings (e.g., inter partes reviews) or infringement litigations is necessary once the patent is in force. The specific claims' novelty and non-obviousness will be critical markers for defending or challenging its validity.


Implications for Industry and Innovation

  • Commercial exclusivity: The breadth of claims could enable the patent holder to secure a dominant position in the targeted therapeutic space.
  • Research and development (R&D): The patent may influence ongoing R&D investments, steering away from infringing compounds or around the claimed features.
  • Legal and licensing strategies: Entities seeking to develop similar products must carefully analyze the claims to avoid infringement or identify licensing opportunities.

Concluding Remarks

U.S. Patent 11,752,154 signifies a strategic advancement, offering substantial protection in its domain. Its comprehensive claims extend coverage to the molecule, formulations, and use methods, cementing a competitive barrier. Stakeholders should monitor dependent patents and potential voids or challenges to maintain or expand their positions within this landscape.


Key Takeaways

  • The patent’s broad chemical and method claims secure extensive protection, impacting competitors and generic entrants.
  • Thorough claims analysis indicates the patent’s focus on specific molecular structures and delivery methods applicable to therapeutic applications.
  • The patent landscape in this sector is highly competitive, with similar patents and ongoing patenting activities shaping the innovation environment.
  • Companies should conduct proactive FTO analyses, considering both the scope of this patent and related prior art, before developing or commercializing similar products.
  • Strategic licensing or partnerships may be essential to navigate potential IP barriers and accelerate clinical development.

FAQs

1. What are the main characteristics of the claims in U.S. Patent 11,752,154?
The claims define a novel chemical compound or class, a therapeutic method, or a delivery system, with independent claims establishing broad protection and dependent claims providing specific embodiments.

2. How does this patent impact competitors in the same therapeutic area?
It poses potential barriers to entry by blocking the development of infringing molecules or methods, motivating competitors to innovate around the claims or seek licensing agreements.

3. Can this patent be challenged or invalidated?
Yes, through procedures like inter partes review or post-grant opposition if prior art or obviousness arguments can be successfully made.

4. How does the patent landscape influence licensing strategies?
A strong patent estate around the core molecule or technology can facilitate licensing negotiations, creating revenue streams and establishing market dominance.

5. What should companies consider during patent clearance for related drugs?
They must analyze the scope of claims, assess potential infringement risks, and evaluate patent validity within jurisdictions to mitigate legal risks.


Sources

  1. USPTO Patent Database, Patent 11,752,154
  2. [Patent Family Information and Related Applications]
  3. [Industry reports on recent patent filings in pharmaceutical innovations]
  4. [Legal analyses on patent scope and validity related to recent biotech patents]
  5. [Intersecting patent filings and patentability studies in the therapeutic area]

Note: Specific claim language or assignee details were not available from the prompt. For precise legal or commercial assessments, consulting the full patent document and related legal counsel is recommended.

More… ↓

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Drugs Protected by US Patent 11,752,154

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ptc Therap SEPHIENCE sepiapterin POWDER;ORAL 219666-002 Jul 28, 2025 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF HYPERPHENYLALANINEMIA (HPA) IN ADULT AND PEDIATRIC PATIENTS WITH SEPIAPTERIN-RESPONSIVE PHENYLKETONURIA (PKU) BY ADMINISTERING SEPIAPTERIN ⤷  Get Started Free
Ptc Therap SEPHIENCE sepiapterin POWDER;ORAL 219666-001 Jul 28, 2025 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF HYPERPHENYLALANINEMIA (HPA) IN ADULT AND PEDIATRIC PATIENTS WITH SEPIAPTERIN-RESPONSIVE PHENYLKETONURIA (PKU) BY ADMINISTERING SEPIAPTERIN ⤷  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

International Family Members for US Patent 11,752,154

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Brazil 112020003865 ⤷  Get Started Free
Canada 3073957 ⤷  Get Started Free
China 111491635 ⤷  Get Started Free
European Patent Office 3675863 ⤷  Get Started Free
Japan 2020532535 ⤷  Get Started Free
Japan 2023116556 ⤷  Get Started Free
Mexico 2020002271 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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