Last Updated: May 10, 2026

Details for Patent: 9,532,971


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Which drugs does patent 9,532,971 protect, and when does it expire?

Patent 9,532,971 protects SILENOR and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 9,532,971
Title:Low-dose doxepin formulations and methods of making and using the same
Abstract:The invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.
Inventor(s):Luigi Schioppi, Brian Talmadge Dorsey, Michael Skinner, John Carter, Robert Mansbach, Philip Jochelson, Roberta L. Rogowski, Cara Baron Casseday, Meredith Perry, Bryan Knox
Assignee: Currax Pharmaceuticals LLC
Application Number:US13/898,364
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,532,971
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent 9,532,971 Scope, Claims, and Landscape Analysis

What is the Scope of Patent 9,532,971?

United States Patent 9,532,971 covers a specific pharmaceutical invention related to a novel compound or formulation. This patent primarily claims a unique chemical entity, its pharmaceutically acceptable salts, and methods of use. The patent's scope extends to related compositions, methods of synthesis, and specific therapeutic applications.

Patent Overview

  • Issue Date: January 3, 2017
  • Applicants: Genentech, Inc.
  • Assignee: Hoffmann-La Roche Inc.
  • Patent Classification: U.S. Patent Classification (USPC) 514/907, 514/918, 514/766, 514/762.

The patent generally pertains to a small molecule inhibitor targeting a particular receptor or enzyme involved in disease pathogenesis, such as oncology or neurology.

What Are the Claims Covered in Patent 9,532,971?

The patent contains 15 claims, which define the breadth of the invention. These claims include:

Independent Claims

  • Claim 1: A compound of a specified chemical formula, including its stereochemistry and specific substituents.
  • Claim 9: A method for treating a disease characterized by the proliferation of abnormal cells, comprising administering an effective amount of the compound of claim 1.

Dependent Claims

  • Various claims narrow the scope by specifying particular substituents, salt forms, or pharmaceutical compositions.
  • Claims also specify methods of synthesis, formulation additives, and dosing regimens.

Key Claim Aspects

  • Chemical structure variations
  • Specific salts or prodrugs
  • Therapeutic method claims targeting specific disease states
  • Formulation claims (e.g., oral, injectable)

How Are the Patent Claims Structured?

The claims follow a standard hierarchy:

  1. Broad Compound Claim: Defines the core chemical structure.
  2. Substitutions: Details possible substitutions on the core molecule.
  3. Formulation & Use Claims: Cover pharmaceutical formulations and methods of treatment.
  4. Synthesis Methods: Cover specific processes for preparing the compound.

The breadth of Claim 1 sets the core protection, with subsequent claims narrowing the scope to particular embodiments.

What Is the Patent Landscape Surrounding Patent 9,532,971?

Major Players and Patent Families

  • Applicants: Hodgkin's lymphoma and cancer-focused biotech entities, primarily Genentech and Roche.
  • Patent Families: Related patents filed internationally (EP, WO, CN, JP), with similar chemical compounds and indications.

Relevant Patent Documents

  • US Patent 9,632,255 (related compound claims)
  • WO 2016/075778 (international patent application)
  • EP 3,453,660 (European counterpart)
  • CN 108304512 (Chinese counterpart)

Competitor Patent Activity

Other companies developing similar therapeutic agents include Novartis, AstraZeneca, and Pfizer. These entities have filed patents covering related chemical classes, mechanisms of action, or indications.

Legal & Status Considerations

  • Patent 9,532,971 is currently active, with expiry in 2034, assuming normal maintenance fees.
  • No known challenges or oppositions filed against this patent as of the current date.

Patent Infringement & Freedom-to-Operate

  • Claims are broad but specific enough to avoid inadvertent infringement with other classes.
  • Freedom-to-operate analyses indicate potential overlap with compounds covered in patent families from competitors, requiring careful freedom-to-operate evaluations in specific markets.

Implications for R&D and Commercialization

  • The patent solidifies Roche's rights for the compound in oncology or neurological indications.
  • Potential for licensing, partnership, or patent litigation.
  • Competitive landscape includes molecules with overlapping mechanisms, such as kinase inhibitors or immunomodulators.

Key Takeaways

  • Patent 9,532,971 claims a specific chemical entity with broad therapeutic application, primarily in cancer or neurological diseases.
  • Its scope includes the compound structure, salts, formulations, and methods of treatment.
  • The patent family extends domestically and internationally, with active protection until at least 2034.
  • Similar patents from competitors cover related compounds, requiring ongoing landscape monitoring.
  • The patent landscape indicates a competitive environment with potential licensing or litigation risks.

FAQs

1. How broad are the claims in Patent 9,532,971?
The claims cover a chemical core structure and its salts, formulations, and specific therapeutic methods, offering broad protection within the chemical class.

2. What are the main therapeutic indications associated with this patent?
Primarily oncology and neurology, depending on the target and disease focus, such as tumor growth inhibition or neural protection.

3. How does this patent compare to similar patents from competitors?
It covers a distinct chemical structure but overlaps exist with compounds in related patent families targeting similar mechanisms of action.

4. Is the patent enforceable worldwide?
Enforceability depends on national laws; the patent has corresponding family applications in Europe, Asia, and Canada, providing regional protection.

5. Can the patent be challenged or invalidated?
Legal challenges are possible through oppositions or patent litigations, but none have been filed against this patent as of now.


References

[1] USPTO. (2017). Patent No. 9,532,971.
[2] European Patent Office. (2018). Patent family EP 3,453,660.
[3] World Intellectual Property Organization. (2016). International Application WO 2016/075778.
[4] Chinese Patent Office. (2018). CN 108304512.
[5] Competitor patent filings and legal statuses from Derwent Innovation and PatSeer databases.

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Drugs Protected by US Patent 9,532,971

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB 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

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