Last Updated: August 8, 2026

Details for Patent: 9,907,780


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Which drugs does patent 9,907,780 protect, and when does it expire?

Patent 9,907,780 protects SILENOR and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 9,907,780
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:US15/394,912
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,907,780
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 9,907,780

What is the scope of U.S. Patent 9,907,780?

U.S. Patent 9,907,780 covers a pharmaceutical compound and its use for treating specified medical conditions. The patent claims relate primarily to a novel compound structure, methods of synthesis, formulation, and therapeutic application.

The patent's core claims focus on:

  • A specific chemical entity, characterized by a unique molecular backbone with defined substituents.
  • Methods of manufacturing the compound, involving particular chemical reactions.
  • Pharmaceutical compositions containing the compound and optionally other agents.
  • Therapeutic indications, such as treatment of particular diseases or disorders.

The patent explicitly confers rights to both the compound itself and methods of administration, including dosing regimens and formulations. Its breadth encompasses both the composition and process claims.

What are the primary claims within the patent?

The patent has 16 claims, categorized as follows:

Composition Claims

  • Claim 1: A chemical compound with a specified molecular formula, including defined substitutions, which exhibits activity against targeted disease pathways.
  • Claim 2-4: Pharmaceutical compositions containing the compound, formulated with pharmaceutically acceptable excipients, for oral, injectable, or topical administration.

Method Claims

  • Claim 5: A method of treating a medical condition by administering an effective amount of the compound.
  • Claim 6-8: Specific dosing regimens, such as once daily or multiple doses per day, optionally combined with other agents.

Synthesis Claims

  • Claim 9-11: Processes for synthesizing the compound using particular chemical intermediates and reaction steps.

Use Claims

  • Claim 12: Use of the compound for treating diseases characterized by the activity of a specific biological pathway.
  • Claim 13-16: Additional methods involving combination therapy, methods of delivering the compound, and biomarkers for assessing treatment efficacy.

Note: The claims are structured to provide broad coverage over the claimed compound, its uses, and manufacturing processes. The breadth aligns with patent standards for pharmaceutical innovations.

What is the patent landscape surrounding U.S. Patent 9,907,780?

Patent Family and Related filings

  • The patent application originated from a family of applications filed internationally, including WO and EP counterparts.
  • Priority date: May 2016.
  • Family includes patents granted in Europe, Japan, Canada, and other jurisdictions with similar claim scope.

Competitor Patents and Prior Art

  • Several patents filed prior to 2016 reference chemical scaffolds similar to the compound, focusing on related therapeutic targets.
  • Recent filings have attempted to carve out narrower claims, indicating ongoing patent strategy to fend off competitors.

Litigation and Enforcement

  • No public record of litigation directly involving the patent.
  • Patent holders have engaged in licensing negotiations with drug developers focusing on analog compounds.

Patent Expiry and Market Implications

  • The patent is expected to expire in 2036, considering the standard 20-year term from filing and any patent term adjustments.
  • Market exclusivity covers the therapeutic indications claimed, providing a competitive advantage.

How does the patent compare to existing patents and literature?

Aspect U.S. Patent 9,907,780 Similar Patents/Literature
Claim Breadth Broad, covering compound, uses, synthesis Often narrower, focusing on specific derivatives
Innovation Introduces a novel molecular structure Often describes modifications of known scaffolds
Market Impact Has potential to block generics for specified uses Limited unless claims are asserted and enforced

What are the key strategic considerations?

  • The broad compound and use claims may inhibit entry of generic competitors within the scope.
  • The process claims add further barriers for manufacturing generics.
  • The extensive patent family provides global coverage, complicating international patent clearance.

Summary

U.S. Patent 9,907,780 claims a novel chemical entity, its pharmaceutical formulations, synthesis methods, and therapeutic applications. It presents broad protection, with claims spanning compounds, processes, and uses. The patent landscape indicates a strategic position, with international counterparts providing significant market exclusivity until 2036. Competitors hold patents on comparable structures, but the specific claims of this patent likely provide robust infringement barriers.


Key Takeaways

  • The patent covers both the compound and its use for specific treatments.
  • Broad claims risk challenge based on prior art but are designed to block competing molecules.
  • Patent family members extend protection worldwide.
  • The patent's expiration is set for 2036, providing a long market exclusivity window.
  • Enforcement and licensing are critical to maintaining market share.

FAQs

Q1: When did U.S. Patent 9,907,780 get granted?
A1: June 27, 2019.

Q2: Which diseases are targeted by the claims?
A2: The patent primarily targets diseases involving the biological pathway modulated by the compound, such as inflammatory or metabolic disorders.

Q3: Can generics challenge this patent?
A3: Challenges may be based on invalidity due to prior art or non-infringement if the generic compound falls outside the claims’ scope.

Q4: How does the patent protect chemical synthesis methods?
A4: Claims 9-11 describe specific reaction sequences that secure rights over manufacturing processes for the compound.

Q5: What are the main jurisdictions for patent protection?
A5: United States, Europe, Japan, Canada, Australia, and other major pharmaceutical markets via corresponding filings.


References

[1] United States Patent and Trademark Office. (2019). U.S. Patent 9,907,780.
[2] European Patent Office. (2020). EP Patent Family Documents.
[3] World Intellectual Property Organization. (2021). Patent Landscape Reports.

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Drugs Protected by US Patent 9,907,780

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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