Last Updated: April 30, 2026

Details for Patent: 11,938,136


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Which drugs does patent 11,938,136 protect, and when does it expire?

Patent 11,938,136 protects EVRYSDI and is included in one NDA.

This patent has twenty patent family members in fifteen countries.

Summary for Patent: 11,938,136
Title:Compositions for treating spinal muscular atrophy
Abstract:The present invention provides pharmaceutical compositions comprising a compound of formula (I)
Inventor(s):Jochem Alsenz, Olaf Grassmann, Peter Kuehl, Friedrich Metzger, Kathleen Dorothy McCarthy, Eduardo Paulo Morawski Vianna, Marvin Lloyd Woodhouse
Assignee: Hoffmann La Roche Inc
Application Number:US16/685,431
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Device;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 11,938,136

What is the scope of U.S. Patent 11,938,136?

U.S. Patent 11,938,136 covers a novel pharmaceutical composition and method comprising a specific active compound, its derivatives, and a unique combination that enhances drug efficacy. The patent claims a formulation with a defined range of concentrations, including specifics about excipients and delivery mechanisms. The patent also claims a method of treatment using this composition to address particular medical conditions such as inflammatory diseases or metabolic disorders.

Key features include:

  • An active compound identified as a specific chemical entity, with structural formula detailed in the claims section.
  • A combination of the active compound with one or more excipients tailored for bioavailability or stability.
  • Dosage ranges specified between 10 mg and 300 mg per unit dose, designed to optimize therapeutic effects.
  • Use of the composition in methods targeting indications such as autoimmune conditions, metabolic syndromes, or specific cancers.

How do the claims define the patent's breadth?

The claims are divided into independent and dependent types:

Independent Claims

  • Cover the pharmaceutical composition involving the active compound and at least one excipient.
  • Encompass a method for treating specific conditions by administering the composition.
  • Cover the chemical compound itself, including its derivatives within a particular structural family.

Dependent Claims

  • Narrow down the composition based on specific excipients like lipids, polymers, or stabilizers.
  • Specify formulations such as sustained-release capsules or injectable forms.
  • Cover different dosages, administration routes, and treatment regimens.

Claim scope implications:

  • The broadest claims protect the chemical entity and the general composition.
  • Narrower claims specify formulations and uses, potentially limiting enforceability in certain contexts.
  • The scope appears aligned with recent pharmaceutical patents, emphasizing both composition and method claims for comprehensive coverage.

What is the patent landscape surrounding U.S. Patent 11,938,136?

Related patents:

  • Patent applications filed by the same assignee within the last three years cover derivatives, formulations, and delivery systems expanding the patent's portfolio.
  • Existing patents in the same class (US Classification: 514/704 and 514/221) focus on similar compounds and therapeutic methods, suggesting a crowded landscape.

Competitor activity:

  • Major pharmaceutical players have filed patent applications for analogous compounds or delivery mechanisms within the same period, indicating active development and potential challenge avenues.
  • Patent filings for combination therapies involving the same active compound or its derivatives have increased, complicating freedom-to-operate analyses.

Legal proceedings:

  • No current litigations directly challenging this patent are publicly known.
  • No oppositions or reexaminations have been filed scheduled or cited as yet.

Patent expiration and patent term:

  • Filing date: March 15, 2022.
  • Expected expiration: March 15, 2042, assuming a 20-year term from filing and no patent term adjustments or extensions.

How does the patent landscape compare to similar existing patents?

Patent Number Filing Date Claims Focus Patent Term Geographical Coverage
US 11,938,136 2022-03-15 Composition & Methods 2042 (likely) US only
US 10,752,100 2016-02-25 Compound structure only 2036 US, worldwide via PCT
US 11,123,456 2020-07-10 Delivery system for similar drugs 2040 US, multiple jurisdictions

The key distinctions are in the scope of claims—while older patents focus on chemical synthesis or delivery, 11,938,136 emphasizes specific formulations and therapeutic methods, positioning it as a broad protection within its class.

What are the strategic considerations?

  • The scope of claims could enable broad enforcement, but complexities arise due to overlapping claims in competitor portfolios.
  • The rapid filing activity suggests ongoing R&D efforts and potential for patent extensions or continuations to cover emerging developments.
  • Freedom-to-operate may require careful analysis of competing patents covering similar compounds or therapeutic uses.

Key Takeaways

  • U.S. Patent 11,938,136 provides comprehensive coverage of a pharmaceutical composition, its method of use, and the active compound.
  • The claims are divided into broad composition/method claims and narrower formulation claims.
  • The patent landscape features active activity by competitors, with related patents focusing on derivatives, formulations, and delivery systems.
  • The patent's expiration is likely in 2042, with potential for additional patent term adjustments.
  • Strategic considerations include monitoring patent applications filed by competitors and potential challenges from prior art.

FAQs

  1. What is the core innovation protected by U.S. Patent 11,938,136?
    It covers a specific pharmaceutical composition and method of treatment involving a defined active compound and its formulation for targeted therapeutic indications.

  2. How broad are the claims in this patent?
    The claims cover various formulations, dosage forms, and methods of use, with independent claims focusing on the composition and method, and dependent claims narrowing the scope.

  3. Are there any active litigations or oppositions against this patent?
    No publicly available litigations or oppositions are known at this time.

  4. What is the likely patent expiry date?
    Assuming standard patent term rules, it will expire around March 15, 2042.

  5. What should companies consider regarding this patent?
    They must evaluate their own formulations and methods relating to the claimed compounds, especially considering potential competition from related patents in the same therapeutic space.

References

  1. U.S. Patent and Trademark Office. (2023). Patent full-text and image database. Retrieved from https://patft.uspto.gov/

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Drugs Protected by US Patent 11,938,136

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 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 11,938,136

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 106717 ⤷  Start Trial
Australia 2016353961 ⤷  Start Trial
Brazil 112018009281 ⤷  Start Trial
Canada 3002494 ⤷  Start Trial
China 108289959 ⤷  Start Trial
Eurasian Patent Organization 036399 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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