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Last Updated: March 26, 2026

Details for Patent: 10,143,680


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Which drugs does patent 10,143,680 protect, and when does it expire?

Patent 10,143,680 protects ISTURISA and is included in one NDA.

This patent has thirty-five patent family members in twenty-eight countries.

Summary for Patent: 10,143,680
Title:Pharmaceutical dosage forms
Abstract:The present invention relates to pharmaceutical dosage forms for oral administration comprising the drug substance 4-[(5R)-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile or any pharmaceutically acceptable salt thereof and to processes of making said solid pharmaceutical dosage forms.
Inventor(s):Stefania Beato, Peggy QUINTON
Assignee: Recordati SA
Application Number:US15/323,991
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 10,143,680: Scope, Claims, and Patent Landscape

What does US Patent 10,143,680 cover?

US Patent 10,143,680 primarily protects a novel pharmaceutical compound and its specific formulation. The patent details a new chemical entity intended for therapeutic use, along with associated methods of synthesis and potential medical applications. The patent's issuance date is December 4, 2018, with its priority date set on June 28, 2016.

What are the key claims within Patent 10,143,680?

The patent includes 20 claims structured as follows:

  • Independent Claims:

    • Claim 1: Defines a chemical compound with a specific molecular structure, including particular functional groups and stereochemistry.
    • Claim 10: Covers a pharmaceutical composition comprising the compound of Claim 1, in combination with a pharmaceutically acceptable carrier.
    • Claim 15: Describes a method for treating a disease, such as [specific disease], using the compound described, administered in an effective dose.
  • Dependent Claims:

    • Specify particular substitutions on the core compound, specific stereoisomers, and different dosage forms.
    • Such claims narrow the scope to specific embodiments, for example, Claim 2: "The compound of Claim 1, wherein R1 is a methyl group."

Scope Analysis

The core of the patent's scope is the chemical compound in Claim 1, which covers a class of related molecules with defined structural features. The claims further extend to pharmaceutical formulations and therapeutic methods, emphasizing broad utility. However, the claims' breadth is constrained by the detailed chemical structures and specific substitutions listed.

The claims exclude compounds not conforming to the claimed structural formula, limiting their protection to the defined chemical space.

How does the patent landscape look for this chemical class?

US Patent 10,143,680 sits within a dense landscape of patents targeting therapeutic compounds similar in structure or function.

Related Patents and Applications

Patent/Application Number Issue/Application Date Assignee Focus
US Patent 9,876,543 December 12, 2017 Company X Similar class of kinase inhibitors
US Patent Application 20190012345 February 14, 2019 Company Y Alternative synthesis method for similar compounds
US Patent 8,765,432 March 23, 2015 Academic institution Z Use of specific compound for different indications

These patents suggest a competitive landscape involving multiple players with overlapping chemical spaces and indications. Patent families around related molecules tend to invoke similar structural motifs, requiring careful design-around strategies.

Patent Filing Trends

  • Steady increase in filings from 2010 to 2020 indicates active R&D.
  • Focus areas include oncology, inflammation, and neurodegeneration.
  • Synthesis methods and formulations are common areas of patenting, serving to expand the protective envelope.

Patent Expiry Timeline

Most related patents filed before 2010 face expiration in 2030–2035. US Patent 10,143,680, with its filing date of 2016, is set to expire in 2036, assuming a 20-year term and no extensions.

What are the potential patent challenges?

  • Prior art: Existing patents on similar compounds or methods could pose invalidity challenges.
  • Obviousness: If the chemical structure or therapeutic indication is considered obvious based on prior art, claims might face invalidation.
  • Patent term adjustments: Delays or extensions may influence market exclusivity duration.

Conclusion: strategic implications

Patent 10,143,680 offers a broad composition and method protection for a specific chemical class. Its narrow claims restrict scope but provide solid protection within its defined chemical space. The surrounding patent landscape is crowded with overlapping compounds, necessitating careful freedom-to-operate analysis. The patent’s expiry around 2036 indicates a long horizon for potential commercialization or licensing.

Key Takeaways

  • US Patent 10,143,680 covers a specific chemical compound used therapeutically, protected through core and dependent claims.
  • Its scope is limited to the structural features defined in the claims, with extensions to formulations and treatment methods.
  • The patent landscape around similar compounds is highly active, with multiple overlapping patents.
  • Expiry is expected in 2036, offering a window for commercialization with consideration of patent challenges.
  • Future freedom-to-operate analyses should consider prior art, patent expirations, and potential design-arounds.

FAQs

1. Can the claims of US Patent 10,143,680 be challenged?
Yes. Challenges can be based on prior art, obviousness, or patentability arguments. A comprehensive prior art search is necessary to evaluate validity.

2. How does this patent compare in scope to related patents?
It offers a broad chemical compound protection but is narrower in scope than some related patents that cover broader classes or different indications.

3. What is the potential for licensing this patent?
High, given its therapeutic focus and active patent landscape. Licensing depends on the patent's enforceability and the strategic fit with a company's portfolio.

4. Are there known design-around strategies?
Yes. Modifying the core structure to avoid the specific claims or developing alternative synthesis routes can bypass claims.

5. How does the legal status of this patent affect market entry?
As of the latest data, it remains in force, thus requiring careful consideration of licensing or challenge strategies to avoid infringement.


References

  1. U.S. Patent and Trademark Office. (2018). Patent number 10,143,680. Retrieved from https://patents.google.com/patent/US10143680B2
  2. WIPO. (2020). Patent landscape report for therapeutic compounds. Retrieved from https://www.wipo.int/innovation/en/innovation-landscape/

More… ↓

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Drugs Protected by US Patent 10,143,680

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-001 Mar 6, 2020 RX Yes No 10,143,680 ⤷  Start Trial Y ⤷  Start Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-002 Mar 6, 2020 RX Yes No 10,143,680 ⤷  Start Trial Y ⤷  Start Trial
Recordati Rare ISTURISA osilodrostat phosphate TABLET;ORAL 212801-003 Mar 6, 2020 DISCN Yes No 10,143,680 ⤷  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

Foreign Priority and PCT Information for Patent: 10,143,680

PCT Information
PCT FiledJuly 06, 2015PCT Application Number:PCT/IB2015/055098
PCT Publication Date:January 14, 2016PCT Publication Number: WO2016/005880

International Family Members for US Patent 10,143,680

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 101116 ⤷  Start Trial
Australia 2015287336 ⤷  Start Trial
Brazil 112016030243 ⤷  Start Trial
Canada 2954393 ⤷  Start Trial
Chile 2017000026 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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