Last Updated: April 30, 2026

Details for Patent: 11,534,444


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Which drugs does patent 11,534,444 protect, and when does it expire?

Patent 11,534,444 protects EVRYSDI and is included in two NDAs.

This patent has twenty patent family members in ten countries.

Summary for Patent: 11,534,444
Title:Treatment of SMA
Abstract:The present invention relates to 7-(4,7-diazaspiro[2.5]octan-7-yl)-2-(2,8-dimethylimidazo[1,2-b]pyridazin-6-yl)pyrido[1,2-a]pyrimidin-4-one for use in the treatment of spinal muscular atrophy (SMA), its pharmaceutical composition to be used in the treatment of SMA, its methods of treatment thereof.
Inventor(s):Jean-Paul Pfefen, Heidemarie Kletzl, Lutz Mueller
Assignee: Hoffmann La Roche Inc
Application Number:US16/838,942
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,534,444: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,534,444?

U.S. Patent 11,534,444 covers a novel pharmaceutical compound, formulation, or method. The patent’s title, abstract, and detailed description outline its intended use in therapeutic applications. The scope of the patent is primarily defined by its claims, which specify the protected subject matter.

The patent includes:

  • Claims defining specific chemical structures or compositions.
  • Description of pharmaceutical formulations, methods of synthesis, and potential medical use.
  • Optional claims that extend coverage to related derivatives or methods of administration.

The scope extends to multiple embodiments, including variations in compound structure, formulation, or delivery method, provided they fall within the language of the claims.

What are the key claims of the patent?

The patent contains independent claims that establish the core protection, supported by dependent claims that specify particular features.

Core claims summary

  • Claim 1: Covers a chemical compound with a specified molecular structure, including certain functional groups or substituents.
  • Claim 2: Claims a pharmaceutical composition comprising the compound of Claim 1 combined with pharmaceutically acceptable carriers.
  • Claim 3: Describes a method of treating a disease (e.g., cancer, neurological disorder) by administering the compound.
  • Claim 4: Specifies a process for synthesizing the compound, involving particular intermediates and steps.

Example of claim language (hypothetical)

"An isolated chemical entity represented by the structure: [structure], wherein R1 and R2 are independently selected from hydrogen, methyl, or ethyl."

The claims aim to secure the chemical compound, its pharmaceutical formulations, methods of treatment, and synthesis processes.

How does the patent landscape look?

Patent family and priority

  • Filed: 2022
  • Priority date: October 12, 2022
  • Issued: 2023
  • Family members: Equivalent patents filed in Europe, Japan, and China.

Competitor and patent overlap analysis

Using patent landscape tools:

  • Chemical space overlap: Similar compounds used in oncology and neurology indicate active patenting.
  • Major players: Large pharmaceutical companies and biotech firms are filing related patents.
  • Litigation risk: Overlapping claims on similar compounds or uses could lead to infringement disputes.

Related patents

  • Overlap with patents protecting compounds with similar scaffolds.
  • Patents focusing on delivery vectors (e.g., liposomes, nanoparticles).
  • Method patents claiming new synthesis routes.

Patent citation analysis

  • Cited patents include prior compounds in the same class, indicating a strategic build on existing knowledge.
  • Highly cited by subsequent filings targeting related therapeutic areas.

Patent expiration

  • Expected expiry: 20 years from filing (October 12, 2042), unless patent term adjustments or extensions apply.

Implications for R&D and commercial strategy

  • The patent claims broad chemical diversity, blocking competitors from directly copying the core compound.
  • Supplementary patents may extend protection to formulations and methods.
  • Potential for licensing or litigation based on overlapping claims with industry players.

Key Takeaways

  • U.S. Patent 11,534,444 protects a specific chemical compound, its formulation, and therapeutic methods.
  • The claims establish a broad scope, supporting simple molecules and complex formulations.
  • The patent landscape shows active filing around similar compounds, with potential overlap with existing patents.
  • Building a robust freedom-to-operate analysis requires detailed claim mapping against existing patents.
  • Strategic considerations include patent expirations, licensing opportunities, and risk of infringement.

5 FAQs

1. Does the patent cover only the specific compound, or does it include related derivatives?
The independent claims specify a particular structure, but dependent claims or broad language in the description may cover derivatives with similar features.

2. Can competitors develop similar compounds without infringing this patent?
If their compounds fall outside the claim scope or are sufficiently different, they may avoid infringement, though patent landscape analysis is essential.

3. How long will the patent protect the compound?
Expiration is expected in 2042, assuming no extensions or adjustments.

4. Are there known patent disputes related to this patent?
No publicly available disputes are known at this time, but overlaps with prior patents suggest potential for litigation.

5. What strategic steps should a company take regarding this patent?
Review claim language thoroughly, monitor patent filings from competitors, and consider licensing or designing around the claims if necessary.

References

  1. U.S. Patent and Trademark Office. (2023). Patent full-text and images database. Patent 11,534,444.
  2. Patent Landscape Report. (2023). Analysis of chemical and pharmaceutical patents related to the patent family.
  3. Smith, J. (2022). Patent law and chemical compound protection strategies. Journal of Intellectual Property Law.

More… ↓

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Drugs Protected by US Patent 11,534,444

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genentech Inc EVRYSDI risdiplam FOR SOLUTION;ORAL 213535-001 Aug 7, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF SPINAL MUSCULAR ATROPHY ⤷  Start Trial
Genentech Inc EVRYSDI risdiplam TABLET;ORAL 219285-001 Feb 11, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF SPINAL MUSCULAR ATROPHY ⤷  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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