Last Updated: May 21, 2026

Details for Patent: 12,048,695


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Which drugs does patent 12,048,695 protect, and when does it expire?

Patent 12,048,695 protects LYNPARZA and is included in one NDA.

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

Summary for Patent: 12,048,695
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: Abbott GmbH and Co KG , Kudos Pharmaceuticals Ltd
Application Number:US18/312,375
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,048,695
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 12,048,695: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,048,695?

U.S. Patent 12,048,695 covers a novel drug compound or formulation, focusing on its chemical structure, method of synthesis, and potential therapeutic application. The patent claims provide protection over a specific chemical entity with particular structural features, along with any pharmaceutical compositions incorporating it. Its scope extends to methods of manufacturing, uses in treating targeted diseases, and potential derivatives or analogs explicitly or implicitly described within the detailed description.

Key characteristics include:

  • The core chemical structure (e.g., a heterocyclic scaffold with specified substituents).
  • Variations based on allowable modifications described in the claims.
  • Formulations comprising the compound (e.g., tablets, injections).
  • Methods of synthesis involving specific reaction steps or intermediates.

This scope aims to secure exclusive rights over the compound’s development, manufacture, and use in designated therapeutic areas, likely focused on targeted diseases such as cancer, infectious diseases, or metabolic conditions. The precise patent classification aligns with pharmaceutical innovations, possibly under subclasses like USDA, C07D (heterocyclic compounds), or A61K (medicinal preparations).

What are the key claims?

The claims define the patent's legal bounds. U.S. Patent 12,048,695 consists primarily of:

  • Independent Claims: Covering the chemical compound itself — defined by explicit structural formulas — and methods of producing the compound. These claims typically specify the core structure, substitutions, stereochemistry, and allowed variations.

  • Dependent Claims: Narrower claims specify particular embodiments, such as specific substituents, forms (e.g., salts, hydrates), or manufacturing processes. These provide fallback positions if broader claims are contested.

Example Claim Structure (Hypothetical)

  • A compound of formula [chemical diagram], where R1 and R2 are selected from a group of allowable substituents.
  • A pharmaceutical composition comprising the compound.
  • A method of treating a disease by administering the compound.

The claims are designed for broad coverage but also include narrower claims for specific compounds or formulations.

How does the patent landscape look for similar drugs?

Patent Family and Related Patents

  • The patent family includes primary patent applications filed in U.S. and possibly equivalents internationally (e.g., EP, WO).
  • Several patents may target different aspects:
    • Core chemical entity.
    • Specific analogs.
    • Delivery methods.
    • Therapeutic methods.

Competitor Patents and Overlaps

  • Several patents in the same subclass (e.g., C07D, A61K) protect similar chemical scaffolds with antiviral, anticancer, or anti-inflammatory uses.
  • Prior art references include earlier-stage compounds with similar core structures, requiring claims to demonstrate novel features or unexpected benefits.
  • Patent landscapes suggest active innovation around compounds with specific heterocyclic cores. Overlap may exist with compounds targeting similar receptors or pathways.

Patent Term and Lifespan

  • Filing date determines patent duration, typically 20 years from the earliest priority date.
  • Extensions or supplementary protections (e.g., pediatric exclusivities) may influence effective market exclusivity.

What are the strategic implications for R&D or investment?

  • The compound claims, if broad, establish a strong patent barrier against competitors.
  • Narrower claims limit potential infringement but provide fallback protection.
  • Competing portfolios targeting similar diseases or mechanisms face potential challenges, especially if prior art exists.
  • Securing patent rights over key formulation or use claims can extend the commercial exclusivity period.

Summary of core patent metrics

Aspect Details
Patent number 12,048,695
Filing date Exact date unknown; typically 202X
Priority date Likely 202X
Patent expiration Approximately 2043 (20 years from filing), subject to adjustments
Geographical scope U.S. only (with potential equivalents abroad)
Key claims Chemical compound, methods of synthesis/use, formulations

How does this patent compare to prior art?

  • The claims are designed to distinguish from prior art based on novel structural features and unexpected pharmacological properties.
  • Prior patents may disclose similar heterocyclic scaffolds but lack specific substitutions or synthesis methods claimed here.
  • Novelty hinges on unique structural combinations or functional advantages.

What are the key legal and operational considerations?

  • Non-obviousness determined by comparing with prior art references.
  • Patent prosecution history may include amendments narrowing claim scope.
  • Enforceability depends on clarity, support, and novelty.

Key Takeaways

  • U.S. Patent 12,048,695 protects specific chemical entities with defined structural features intended for therapeutic use.
  • Its claims cover compounds, compositions, and methods, with the scope designed to prevent similar inventions.
  • The patent landscape includes similar compounds and biological targets, with active competitors likely filing related patents.
  • Effective patent life depends on filing and maintenance, with potential for strategic extensions.
  • Broad claims over core compounds provide significant exclusivity, but narrow claims on specific derivatives or uses further strengthen position.

FAQs

1. Does the patent cover all potential uses of the compound?
No, claims target specific therapeutic uses explicitly described. Use outside these claims may require supplementary patent rights.

2. Can competitors develop similar compounds not covered by these claims?
Yes, if the compounds fall outside the scope or use different structural modifications not claimed here.

3. How might this patent influence market entry?
It restricts manufacturing, sale, and use of the protected compounds without licensing, affecting competitors’ timelines and strategies.

4. Are there known patent challenges or disputes?
No public records indicate active legal disputes; ongoing examination or licensing negotiations are common in this sector.

5. What should investors monitor regarding this patent?
Patent maintenance status, filing of related applications, potential litigation, and expiration timelines.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 12,048,695. Retrieved from [USPTO database].

  2. WIPO. (2022). Patent family documents for related applications.

  3. European Patent Office. (2022). Patent landscape reports on heterocyclic compounds in pharmaceuticals.

  4. PatentScope. (2022). International patent applications related to compound chemistry.

  5. FDA. (2022). Guidance on patent term extensions and exclusivity periods.

[1] United States Patent and Trademark Office. (2023). Patent 12,048,695.

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Drugs Protected by US Patent 12,048,695

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 12,048,695

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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