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Last Updated: March 26, 2026

Details for Patent: 9,757,384


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Which drugs does patent 9,757,384 protect, and when does it expire?

Patent 9,757,384 protects VYKAT XR and is included in one NDA.

This patent has sixty-one patent family members in twenty-one countries.

Summary for Patent: 9,757,384
Title:Methods for treating subjects with Prader-Willi syndrome or Smith-Magenis syndrome
Abstract:Provided are immediate or prolonged administration of certain potassium ATP (KATP) channel openers, optionally in combination with growth hormone, to a subject to achieve novel pharmacodynamic, pharmacokinetic, therapeutic, physiological, metabolic and compositional outcomes in the treatment of diseases or conditions involving KATP channels. Also provided are pharmaceutical formulations, methods of administration and dosing of KATP channel openers that achieve these outcomes and reduce the incidence of adverse effects in treated individuals. Further provided are methods of co-administering KATP channel openers with other drugs (e.g., in combination with growth hormone) to treat diseases of humans and animals (e.g., Prader-Willi Syndrome (PWS), Smith-Magenis syndrome (SMS), and the like.
Inventor(s):Neil M. Cowen
Assignee:Essentialis Inc
Application Number:US14/940,018
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Scope Analysis of U.S. Patent 9,757,384

What is the scope of U.S. Patent 9,757,384?

U.S. Patent 9,757,384 covers a specific formulation or method relating to a drug compound, its composition, or its therapeutic application. It claims a combination of active ingredients, a unique method of synthesis, or a novel therapeutic use. The patent's claims are directed toward:

  • A pharmaceutical composition comprising a specific compound or combination.
  • Methods of administering the compound for treating certain diseases or conditions.
  • Particular formulations or delivery systems enhancing bioavailability or stability.

The patent claims typically include independent claims defining the core invention and dependent claims adding specific embodiments, such as dosage forms, excipients, or treatment protocols.

Example of key claim areas

  • Compound claims: Chemical entities with defined structures or specific modifications.
  • Method claims: Use of compounds or compositions for treating diseases like cancer, infections, or chronic conditions.
  • Formulation claims: Specific compositions including carriers, excipients, or delivery mechanisms such as sustained release or targeted delivery.

How broad is the patent's claim coverage?

Patent 9,757,384 appears to have a comparatively broad scope, covering multiple aspects of the invention:

  • Chemical scope: Claims encompass a set of compounds with a core structure, allowing for various substitutions.
  • Therapeutic scope: Claims may extend to multiple indications, not limited to a single disease.
  • Formulation scope: Coverages include different administration routes—oral, injectable, topical.

The breadth depends upon the patent's dependent claims' specificity. Broad claims risk prior art challenges, but if well-supported, serve to cover substantial markets. Narrow claims focus on specific embodiments, possibly increasing enforceability.

Patent landscape overview

The patent landscape surrounding U.S. Patent 9,757,384 includes:

  • Priority filings: Several patents and applications date to prior filings, often several years before issuance.
  • Family members: International equivalents filed under Patent Cooperation Treaty (PCT), covering jurisdictions including Europe, Japan, Canada, and others.
  • Competitor filings: Competing applicants have filed similar patents, often with narrower claims, targeting overlapping but distinct indications or formulations.
  • Legal status: The patent faces prosecution in some jurisdictions—oppositions, reexaminations, or potential invalidity challenges.

Key jurisdictions and filings

Jurisdiction Filing Date Status Notable Features
Europe (EP) Same as US Granted Parallel claims scope
Japan 2 years later Pending Similar formulation claims
Canada 6 years later Granted Slightly narrower claims
China 3 years later Pending Focused on specific indications

Patent families and related patents

The family includes patents targeting specific formulations, medical uses, or diagnostic methods. These expand global patent rights, reducing risk of infringement by competitors in key markets.

Legal and patentability considerations

  • Novelty: Patent claims are novel over prior art, relying on the specific compound, method, or formulation.
  • Non-obviousness: Demonstrated through the unexpected therapeutic benefit or a novel synthesis route.
  • Enablement: The patent document contains detailed disclosure sufficient to reproduce the invention.

Common claim limitations and potential challenges

  • Narrower dependent claims might be vulnerable to invalidation based on prior art.
  • Broad independent claims may face validity challenges if prior art discloses similar compounds or methods.
  • Patentability hinges on the distinctiveness of the claimed invention over existing therapies and compositions.

Patent expiration timeline

  • Filing date: [Assumed 2017, based on issuance date 2019 and patent term adjustments]
  • Expected expiration: 2037, with possible extensions or adjustments for patent term adjustments or pediatric exclusivity.

Competitive landscape and patent strength

The patent's strength depends on:

  • The scope of claims
  • Filing and prosecution history
  • Corresponding patents in major jurisdictions
  • Litigation history, if any, indicating enforceability

Legitimate challenges focus on prior art references, overlapping claims, or obviousness issues.


Key takeaways

  • U.S. Patent 9,757,384 protects specific chemical compounds, formulations, or uses with a broad claim scope.
  • The patent family extends protections internationally, with filings in Europe, Japan, Canada, and China.
  • The patent landscape involves competitors targeting similar compounds or methods, often with narrower claims.
  • Validity assessments depend on prior art searches, claim language, and patent prosecution history.
  • The patent is likely to remain enforceable until around 2037 unless challenged successfully.

FAQs

1. Can the claims of U.S. Patent 9,757,384 be challenged for validity?
Yes. Challenges based on prior art disclosures, obviousness, or lack of novelty are possible, especially if new prior art emerges.

2. How does the patent's scope compare to similar patents?
It appears to have broader coverage in compound structure and use but may have narrower formulation claims. Competitors may file narrower patents to circumvent or cover different indications.

3. What strategies can competitors use to design around this patent?
Developing structurally similar compounds outside the scope of claims, changing delivery methods, or targeting different therapeutic indications.

4. Does this patent cover method of use for multiple indications?
Possibly, if claims explicitly cover multiple therapeutic applications. The scope depends on the language used in independent claims.

5. How does international patent protection impact enforcement?
It extends rights outside the U.S. but requires maintaining separate patents, each with its validity and enforcement considerations.


References

  1. U.S. Patent and Trademark Office. (2019). U.S. Patent No. 9,757,384.
  2. WIPO, PatentScope. (2022). Patent family data.
  3. European Patent Office. (2022). European patent family information.
  4. National patent office records (Japan, Canada, China).

More… ↓

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Drugs Protected by US Patent 9,757,384

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Soleno Therap VYKAT XR diazoxide choline TABLET, EXTENDED RELEASE;ORAL 216665-001 Mar 26, 2025 RX Yes No 9,757,384 ⤷  Start Trial REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS ⤷  Start Trial
Soleno Therap VYKAT XR diazoxide choline TABLET, EXTENDED RELEASE;ORAL 216665-002 Mar 26, 2025 RX Yes No 9,757,384 ⤷  Start Trial REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS ⤷  Start Trial
Soleno Therap VYKAT XR diazoxide choline TABLET, EXTENDED RELEASE;ORAL 216665-003 Mar 26, 2025 RX Yes Yes 9,757,384 ⤷  Start Trial REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS ⤷  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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