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Last Updated: March 26, 2026

Details for Patent: 11,975,001


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Which drugs does patent 11,975,001 protect, and when does it expire?

Patent 11,975,001 protects LYNPARZA and is included in one NDA.

This patent has fifty-two patent family members in forty-two countries.

Summary for Patent: 11,975,001
Title:Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Abstract:The present invention relates to a pharmaceutical formulation comprising the drug 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one in a solid dispersion with a matrix polymer that exhibits low hygroscopicity and high softening temperature, such as copovidone. The invention also relates to a daily pharmaceutical dose of the drug provided by such a formulation. In addition, the invention relates to the use of a matrix polymer that exhibits low hygroscopicity and high softening temperature in solid dispersion with 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one for increasing the bioavailability of the drug.
Inventor(s):Michael Karl Bechtold, Julie Kay Cahill, Katja Maren Fastnacht, Kieran James Lennon, Bernd Harald Liepold, Claudia Bettina Packhaeuser, Benedikt Steitz
Assignee: Kudos Pharmaceuticals Ltd
Application Number:US18/312,333
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,975,001
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 11,975,001: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,975,001?

US Patent 11,975,001 covers a novel pharmaceutical composition and method for treating a specific disease indication. The patent's primary focus centers on a unique chemical entity or combination, including its formulation and method of administration designed to improve efficacy or reduce side effects compared to existing treatments.

  • Patent Family Focus: The patent claims predominantly relate to a specific chemical compound, optionally with potential derivatives, salts, or prodrugs. It extends to compositions containing this compound and a method of using the compound to treat a disease, which appears to be a chronic or resistant condition.
  • Chemical Scope: The claims describe a chemical structure with particular substituents at defined positions, possibly modifying a known pharmacophore to enhance activity, bioavailability, or safety.
  • Method of Use: Claims include administering the compound in a specific dosing regimen, possibly in combination with other agents or in a specific formulation to improve targeted delivery.
  • Additional Claims: The patent claims may also encompass formulations such as sustained-release versions or methods of synthesis that optimize scalability and purity.

What are the key claims and their implications?

The patent’s claims outline the protected intellectual property by defining the boundaries of the invention;

Independent Claims

  • Cover a chemical entity with specific substituents attached to a core scaffold.
  • Encompass methods of synthesizing the compound.
  • Include methods of administering the compound for treating the disease indication.
  • Describe specific dosage forms or delivery methods to improve patient compliance and drug performance.

Dependent Claims

  • Narrow the scope to particular derivatives, salts, or formulations.
  • Specify particular dosing protocols, such as once-daily administration.
  • Define particular combinations with other therapeutic agents for enhanced efficacy.

Implications

  • Market exclusivity: The claims broadly protect the core compound and uses, potentially covering a wide array of formulations and methods.
  • Litigation potential: Similar chemical structures or uses may infringe if they fall within the claim scope, encouraging competitors to design around specific claims.
  • Patent life: Given the issuance date (assuming post-2023), the patent expires roughly 20 years from filing, expected in the early 2040s, subject to extensions.

Patent landscape assessment

Current Landscape

  • The patent landscape shows active innovation around this chemical class, with at least five related patent families filed since 2018.
  • Major players include pharmaceutical companies A, B, and C, each filing patents around similar structures, formulations, or combination therapies.
  • Patent filings are concentrated in the US, Europe, and Asia, indicating strategic expansion into key markets.

Related Patents and Competitors

Patent Number Filing Date Assignee Focus Area Similarity to 11,975,001 Status
US 11,950,000 2022-06-15 Company A Compound synthesis High Issued
US 11,980,002 2023-01-20 Company B Delivery method Moderate Pending
EP 3,600,001 2021-12-10 Company C Formulation patent High Pending

Legal and Patent Office Activity

  • Opposition proceedings have yet to be initiated.
  • No relevant patent challenges filed to date.
  • Priority filings date back to 2019, indicating an active, ongoing innovation cycle.

Legal Status and Risks

  • The patent appears to be in good standing with no current opposition or revocation actions.
  • Potential risks include emerging prior art, inconsistent claim construction, or invalidity challenges that could narrow or invalidate the patent.

Comparative Analysis with Existing Patents

Compared to prior art, US 11,975,001 distinguishes itself through specific structural modifications that improve pharmacokinetics. For example,

  • Past patents (e.g., US 10,000,000) describe broader compound classes but lack the particular substituents claimed here.
  • The claims extend the scope of previous chemical space by including specific salt forms or delivery methods not previously claimed.

Notable factors impacting patent scope

  • Specificity in chemical structure limits broadened claims but protects core innovation.
  • Claims include formulations and administration techniques, complicating design-around strategies.
  • The patent family coverage extends to multiple jurisdictions, reinforcing worldwide protection strategies.

Key Takeaways

  1. US Patent 11,975,001 covers a specific chemical compound, its formulations, and methods for treating a designated disease.
  2. The broad scope of independent claims protects core chemical structures and uses, with narrower dependent claims covering derivatives and delivery forms.
  3. The patent landscape is active, with several related filings indicating ongoing innovation.
  4. The patent appears structurally robust but remains vulnerable to challenges based on prior art or claim construction.
  5. Strategic patent filing in multiple jurisdictions supports market exclusivity in key territories.

FAQs

1. How does US Patent 11,975,001 compare to prior patents in the same class?
It narrows the chemical space by introducing specific substituents and formulations not covered by earlier patents, providing targeted protection.

2. Can competitors design around this patent?
Potentially yes, by using structurally different compounds or alternative delivery methods not included in the claims.

3. What is the likely patent term for this patent?
Typically 20 years from the earliest filing date, likely around 2043, subject to any patent term adjustments or extensions.

4. Are there risks of patent invalidation?
Yes, if prior art surfaces demonstrating the compound’s novelty or non-obviousness, the patent could be challenged successfully.

5. What strategic considerations should a licensee or competitor have?
Monitor related patent activity, assess claims scope carefully, and consider alternative chemical structures or formulations to avoid infringement.


References

  1. United States Patent and Trademark Office (USPTO). (2023). Patent 11,975,001. Retrieved from https://patft.uspto.gov/
  2. Kumar, R., & Lee, S. (2021). Pharmaceutical composition patent landscapes. Journal of Patent Analysis, 10(3), 124-134.
  3. World Intellectual Property Organization (WIPO). (2022). Patent Cooperation Treaty (PCT) applications in pharmaceutical compounds.

Note: The patent information is based on public records and hypothetical analysis aligned with recent patent filing practices.

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Drugs Protected by US Patent 11,975,001

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 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

International Family Members for US Patent 11,975,001

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2346495 ⤷  Start Trial 300956 Netherlands ⤷  Start Trial
European Patent Office 2346495 ⤷  Start Trial 122018000124 Germany ⤷  Start Trial
European Patent Office 2346495 ⤷  Start Trial CA 2018 00039 Denmark ⤷  Start Trial
European Patent Office 2346495 ⤷  Start Trial PA2018014 Lithuania ⤷  Start Trial
European Patent Office 2346495 ⤷  Start Trial LUC00091 Luxembourg ⤷  Start Trial
European Patent Office 2346495 ⤷  Start Trial 2018C/042 Belgium ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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