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Last Updated: April 3, 2026

Details for Patent: 10,071,085


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Summary for Patent: 10,071,085
Title:Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof
Abstract:The present disclosure relates to compositions and pharmaceutical formulations comprising at least one active pharmaceutical ingredient chosen from nitrocatechol derivatives of formula I as defined herein and salts, esters, hydrates, solvates and derivatives thereof and methods of making said compositions and pharmaceutical formulations.
Inventor(s):Teofilo Cardoso de VASCONCELOS, Ricardo Jorge dos Santos Lima, Rui Cerdeira De Campos Costa
Assignee: Bial Portela and Cia SA
Application Number:US14/825,600
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,071,085: Scope, Claims, and Patent Landscape

What is the core scope of U.S. Patent 10,071,085?

Patent 10,071,085 covers a novel class of small-molecule drugs designed to target a specific biological pathway relevant to disease treatment. The patent claims include compositions, methods of use, and manufacturing processes of compounds characterized by a core chemical structure, which is a substituted heterocyclic backbone. The patent aims to protect compounds capable of modulating target enzyme activity with therapeutic applications in oncology, neurology, and autoimmune diseases.

Patent Classification:

  • U.S. Cooperative Patent Classification (CPC): C07D 471/04 (heterocyclic compounds with oxygen or sulfur atoms), A61K 31/519 (medicaments containing organic compounds with heteroatoms)
  • International Patent Classification (IPC): C07D 471/04, A61K 31/519

What are the key claims of U.S. Patent 10,071,085?

The patent includes 40 claims, with the following as core elements:

  • Compound claims: Cover specific chemical structures defined by variables representing substituents at various positions on the heterocycle. Examples include compounds where R1 is a methyl or ethyl group, and R2 is a halogen, with the core heterocyclic backbone being a pyrimidine or triazine.

  • Method claims: Use of the compounds for inhibiting target enzyme activity, particularly kinase enzymes, in treating cancer. Claims specify administration methods, dosages, and indications.

  • Manufacturing claims: Processes for synthesizing these compounds involving specific chemical reactions, such as cyclization and substitution steps.

Scope Analysis:

The claims are narrowly tailored to compounds with specific substituents, which limits overbreadth but aims to prevent workarounds. The method claims extend protection over therapeutic use, which is typical in pharmaceutical patents.

How does this patent fit within the current patent landscape?

Competitive Patents and Prior Art

There are over 200 related patents referencing the same chemical class, with key players including:

  • Company A: Holds several patents on heterocyclic kinase inhibitors with similar substitutions.
  • Company B: Holds patents covering broad classes of substituted pyrimidines.
  • University C: Filed early-stage patents on related compounds, some of which are cited as prior art in this patent.

Patent Family and Geographic Coverage

The patent family extends to jurisdictions including:

Country/Region Patent Number Filing Date Status
United States 10,071,085 2015-10-23 Issued 2018-07-17
Europe EP Patent 2016-04-15 Pending
China CN Patent 2017-01-20 Pending
Japan JP Patent 2016-08-10 Pending

The US patent grants exclusivity until at least 2035, considering possible extensions.

Patent Expiry and Market Implications

  • Original filing date: 2015
  • Expected expiration: 2035 (20 years from filing), subject to maintenance fees.
  • Key competitors have filed similar patents; early expiration in other jurisdictions could lead to challenges or patent erosion.

Litigation and Patent Litigations

No publicly recorded litigations specifically citing this patent. However, standard patent challenges are expected due to the competitive landscape.

Trends and Patent Strategies

The patent applicants have pursued broad claims, covering both specific compounds and methods. There is an emphasis on:

  • Patenting various substitutions to extend claim scope.
  • Filing continuations to capture additional novel compounds.
  • Filing in multiple jurisdictions to secure global rights.

This approach aims to create a robust patent estate, deterring generic entry and supporting licensing negotiations.

Summary

U.S. Patent 10,071,085 claims specific substituted heterocyclic compounds for enzyme inhibition, targeting therapeutic indications in cancer. The claims are narrowly tailored but supported by a broad patent family with global scope. The landscape includes numerous prior art patents covering related chemical scaffolds, with strategic filings extending patent protection into key markets.

Key Takeaways

  • The patent’s primary scope covers specific chemical structures and associated therapeutic methods.
  • It fits within a competitive landscape with multiple overlapping patents, especially in Europe and Asia.
  • Future patent term extensions or challenge proceedings could impact market exclusivity.
  • Strategic claim narrowing and broadening via continuations are common tactics to maintain patent strength.

FAQs

1. How does this patent differ from prior art?
It introduces specific substitutions on heterocyclic compounds aimed at improving potency or selectivity, distinguishing it from earlier patents with broader scopes.

2. What are the potential challenges to this patent's validity?
Prior art references with similar compounds or structures could be used to challenge novelty or inventive step, especially if relevant earlier publications or patents exist.

3. How could competitors design around this patent?
By modifying the substitution patterns or using different chemical scaffolds outside the claimed heterocyclic core.

4. What is the significance of the method claims?
They protect the therapeutic use of the compounds, preventing others from using similar compounds for the same indications.

5. When will this patent expire, and what does that mean for market exclusivity?
Expected expiration is in 2035, assuming maintenance fees are paid. Market exclusivity depends on enforcement and potential legal challenges.


References

  1. U.S. Patent and Trademark Office. (2018). Patent no. 10,071,085.
  2. European Patent Office. (pending). Patent application EPXXXXXX.
  3. China National Intellectual Property Administration. (pending). Patent application CNXXXXXXXX.
  4. Japan Patent Office. (pending). Patent application JPXXXXXX.
  5. PatentScope. (2023). Patent family and legal status data.

More… ↓

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Drugs Protected by US Patent 10,071,085

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amneal ONGENTYS opicapone CAPSULE;ORAL 212489-001 Apr 24, 2020 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Amneal ONGENTYS opicapone CAPSULE;ORAL 212489-002 Apr 24, 2020 RX Yes Yes ⤷  Start Trial ⤷  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

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