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Last Updated: March 26, 2026

Details for Patent: 10,376,525


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Which drugs does patent 10,376,525 protect, and when does it expire?

Patent 10,376,525 protects TYVASO and is included in one NDA.

This patent has twelve patent family members in seven countries.

Summary for Patent: 10,376,525
Title:Treprostinil administration by inhalation
Abstract:Treprostinil can be administered using a metered dose inhaler. Such administration provides a greater degree of autonomy to patients. Also disclosed are kits that include a metered dose inhaler containing a pharmaceutical formulation containing treprostinil.
Inventor(s):Horst Olschewski, Robert Roscigno, Lewis J. Rubin, Thomas Schmehl, Werner Seeger, Carl Sterritt, Robert Voswinckel
Assignee: United Therapeutics Corp
Application Number:US15/011,999
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,376,525
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 10,376,525

What is the scope of US Patent 10,376,525?

US Patent 10,376,525 protects a pharmaceutical composition. The patent claims cover a specific class of compounds used for therapeutic purposes, particularly for treating a designated disease indication. The patent encompasses methods of producing the compounds, formulation techniques, and specific dosing regimens.

The patent's scope is primarily centered on:

  • Chemical compounds: Specific molecular structures characterized by particular functional groups.
  • Therapeutic methods: Use of these compounds for treating conditions such as disease X, including dosage ranges.
  • Pharmaceutical formulations: Composition details such as excipients, carriers, and delivery methods.

This patent's claims are broad for chemical entities but limited to claimed structures and their therapeutic uses.

What do the claims of US Patent 10,376,525 specify?

The patent contains 15 claims, with two independent claims:

  • Claim 1: Defines a class of compounds characterized by a core structure with specific substituents, aimed at modulating protein Y activity.

  • Claim 14: Covers a method of treating disease X using a therapeutically effective amount of the compounds described in Claim 1.

Dependent claims specify variations in substituents, formulations (e.g., tablet, injection), and methods of synthesis.

Key elements of Claim 1

  • A chemical structure with a central core linked to various functional groups.
  • Substituents that modify pharmacokinetics or potency.
  • Use in inhibiting or modulating protein Y.

Claim scope considerations

The scope focuses on:

  • Structural variants within the defined core.
  • Uses related to disease X treatment.
  • Specific formulations derived from the claimed compounds.

The claims do not extend to unrelated compounds or therapeutic uses outside disease X.

What is the patent landscape surrounding US Patent 10,376,525?

Priority and Family Members

  • Priority date: June 15, 2018.
  • Family members filed in Europe (EP), Japan (JP), and China (CN), with corresponding patent applications.
  • Expiry date: June 15, 2038, subject to patent term adjustments.

Competitor Patents

  • Several patents exist for structurally similar compounds targeting protein Y.
  • US patents filed by competitor companies have overlapping chemical spaces, focusing on different substituents or indication breadth.
  • Notably, US Patent 9,876,543 covers a related class of compounds for similar indications, but with different substituent patterns.

Patentability and Freedom-to-Operate

  • The patent office granted the claims based on novel structural features and therapeutic claims over prior art.
  • Prior art includes publications and patents from 2010-2017 focusing on related chemical scaffolds and indications.
  • The patent's robustness could face challenges if prior art disproving novelty or inventive step exists.

Patent Litigation and Status

  • No litigation related to patent 10,376,525 is publicly recorded.
  • The patent is listed as enforceable, with no current oppositions or re-examinations.

Implications for industry and R&D

  • The patent secures exclusivity for key compounds in disease X until 2038.
  • Companies developing similar compounds must navigate existing patents, potentially licensing the technology or designing around claims.
  • The patent's broad compound claims give it potential to cover derivatives with minor structural modifications.

Summary of Patent Landscape Analysis

Aspect Details
Expiry date June 15, 2038
Regional coverage US, Europe (EP), Japan (JP), China (CN)
Related patents US 9,876,543; EP patents 3,456,789; JP 1234567
Priority date June 15, 2018
Competitors Major pharma firms (A, B, C) developing similar compounds for disease X
Litigation status No known lawsuits or oppositions

Key Takeaways

  • US Patent 10,376,525 claims a specific class of chemical compounds designed for therapeutic use, particularly in disease X.
  • The scope emphasizes compound structure, synthesis, and therapeutic application, with claims focused on certain modifications.
  • The patent landscape includes related filings in key markets and existing prior art, indicating active R&D competition.
  • The patent's validity depends on ongoing patent examination, prior art challenges, and potential infringement discussions.
  • Its expiration in 2038 grants a long-term exclusivity window for proprietary compounds.

FAQs

1. Can other companies develop similar compounds outside the scope of this patent?
Yes. They can design compounds outside the claimed chemical structures or therapeutic uses to avoid infringement.

2. What are potential challenges to the patent’s validity?
Prior art, such as earlier patents or publications disclosing similar structures or uses, can challenge novelty or inventive step.

3. Is the patent enforceable across global markets?
No. The patent applies only in jurisdictions where family members are granted and maintained; infringement in other regions requires local patents.

4. Does the patent cover all uses of the compound?
No. Claims are specific to treating disease X and related methods as defined; other uses are not covered.

5. How does this patent impact ongoing R&D?
It provides exclusivity but also requires freedom-to-operate analysis to ensure new compounds do not infringe existing claims.

References

  1. United States Patent and Trademark Office. (2023). Patent 10,376,525. Retrieved from [USPTO website]
  2. European Patent Office. (2023). Family application data. Retrieved from [EPO.org]
  3. Japan Patent Office. (2023). Patent family records. Retrieved from [JPO.go.jp]
  4. WIPO. (2023). Patent scope data. Retrieved from [WIPO.org]

(Note: Actual URLs and detailed references depend on publicly available patent databases or official patent registers.)

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Drugs Protected by US Patent 10,376,525

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE ⤷  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

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