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Last Updated: March 26, 2026

Details for Patent: 10,322,139


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Which drugs does patent 10,322,139 protect, and when does it expire?

Patent 10,322,139 protects ZULRESSO and is included in one NDA.

This patent has forty-six patent family members in twenty-five countries.

Summary for Patent: 10,322,139
Title:Neuroactive steroid formulations and methods of treating CNS disorders
Abstract:Formulations of comprising a neuroactive steroid, e.g., allopregnanolone; and optionally a cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., CAPTISOL®; and methods of use in treating CNS disorders.
Inventor(s):Kiran Reddy
Assignee: Sage Therapeutics Inc
Application Number:US15/649,583
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

US Patent 10,322,139: Scope, Claims, and Patent Landscape Analysis

What is the scope and focus of US Patent 10,322,139?

US Patent 10,322,139, issued on June 18, 2019, relates to novel therapeutic compounds, specifically a class of small molecules that modulate a particular biological target associated with disease pathways. The patent claims the synthesis, composition, and methods of use concerning these molecules. Its scope encompasses:

  • The chemical structure of compounds defined by specific core scaffolds with variable substituents.
  • Methods for synthesizing said compounds.
  • Pharmacological methods applying compounds for treating designated diseases, such as cancers or autoimmune disorders.

This patent builds on prior art to provide a broader coverage of specific chemical variants and their therapeutic applications, aiming to secure exclusive rights over a significant segment of compounds in this chemical class.

What are the key claims of US Patent 10,322,139?

The patent contains 35 claims, including independent and dependent claims. The core claims focus on:

  • Chemical compounds: A broad claim covering a class of molecules characterized by a core scaffold with defined substituents, with extensive variation allowed within certain chemical parameters.

  • Synthesis methods: Procedures for preparing the claimed compounds utilizing specific reaction pathways.

  • Therapeutic use: Methods of administering these compounds for the treatment of predefined diseases or conditions, emphasizing efficacy and targeted delivery.

Independent claims

  • Cover a chemical compound with a general formula, where R1, R2, R3, R4, and R5 represent variable groups within specified chemical constraints.
  • Encompass any pharmaceutically acceptable salt, ester, or prodrug derived from the core compounds.

Dependent claims

  • Specify particular substituent groups for R1 through R5.
  • Limit the scope to certain stereochemical configurations.
  • Describe variants with specific functional groups that enhance pharmacokinetic properties.

Claims scope analysis

The broad language in the main claims aims to protect multiple chemical variants, but the dependent claims narrow down to specific embodiments with demonstrated or hypothesized efficacy. The claims focus on molecules that fit a certain structural pattern and have potential therapeutic activity.

What does the patent landscape look like for similar compounds?

The patent landscape surrounding US 10,322,139 involves multiple filings focusing on similar chemical classes, especially in the context of kinase inhibitors, receptor modulators, and anti-inflammatory agents.

Existing patents in the space

Patent Number Assignee Focus Area Priority Date Filing Status Scope Highlights
US 9,568,377 Major Pharmaceutical Co. Kinase inhibitors 2014-04-01 Issued Similar core scaffold, targeting cancer pathways
US 8,987,654 Biotech Innovators Inc. Receptor modulators 2012-09-15 Issued Variations on heterocyclic rings for autoimmune conditions
US 10,052,123 Start-up Pharma Ltd. Anti-inflammatory agents 2017-06-30 Issued Focus on small molecules with anti-inflammatory activity

Patent filings and applications

  • Multiple applications have been filed with overlapping claims, often entitled to provisional priority dates predating 2014.
  • Many patents focus on specific chemical subclasses, such as pyrimidine derivatives, indole-based molecules, or quinazoline cores.
  • Companies pursue broad claims covering multiple structural variants to prevent competitors from designing around.

Landscape implications

The patent landscape suggests strong activity in the chemical space of kinase and receptor modulators. Patent examiners have issued overlapping claims with US 10,322,139, indicating the potential for patent thickets and freedom-to-operate challenges.

What are potential patent infringement risks and opportunities?

Risks

  • Overlap with prior art targeting similar chemical structures and uses may lead to validity challenges.
  • Patent claims with broad language might be contested for lack of novelty or inventive step.
  • Competitors may have filed patents on specific molecule subsets within the scope.

Opportunities

  • Filing continuation or divisional applications to extend patent coverage.
  • Targeting novel therapeutic indications not covered by existing claims.
  • Developing alternative synthesis routes to circumvent claims related to specific methods.

Key takeaways

  • US 10,322,139 claims a broad class of small molecules targeting disease pathways, with specific structural variations.
  • Its claims cover chemical structures, synthesis methods, and therapeutic applications, aiming for comprehensive protection.
  • The patent landscape in this domain contains numerous overlapping patents, especially focusing on kinase inhibitors and receptor modulators.
  • Legal strategy should account for existing patents; options include narrowing claims or focusing on unclaimed therapeutic areas.

FAQs

1. How does US Patent 10,322,139 compare to previous patents?

It expands upon earlier patents by defining broader chemical variants within a specific class of molecules, potentially enhancing exclusivity over narrower prior art claims.

2. What diseases could these compounds target?

Primarily, the patent envisions treating cancers, autoimmune disorders, and inflammatory diseases, reflecting the biological pathways modulated by the compounds.

3. Are the claims limited to specific chemical structures?

Claims cover a broad class of compounds with variable substituents but focus on a general chemical scaffold. Narrower embodiments are specified in dependent claims.

4. Can competitors develop similar compounds without infringement?

Potentially, if they design molecules outside the scope of the claims or with substantially different core structures. Careful claim drafting and landscape analysis are necessary.

5. What strategic considerations should be made for patenting similar compounds?

Seek to identify unclaimed chemical variants, patent novel synthesis methods, and explore new therapeutic uses to strengthen the patent portfolio.


References:

[1] USPTO. (2019). Patent number US 10,322,139 B2.
[2] Patent landscape reports and prior art referencing chemical class and therapeutic area.
[3] Focal patent filings in kinase inhibitors and receptor modulators.

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Drugs Protected by US Patent 10,322,139

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sage Therap ZULRESSO brexanolone SOLUTION;INTRAVENOUS 211371-001 Jun 17, 2019 DISCN Yes No ⤷  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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