You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 16, 2025

Details for Patent: 11,236,121


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 11,236,121 protect, and when does it expire?

Patent 11,236,121 protects ZURZUVAE and is included in one NDA.

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

Summary for Patent: 11,236,121
Title:Crystalline 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid
Abstract:This invention relates to a 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) and crystalline solid forms and compositions thereof. Also disclosed herein are methods of making crystalline solid forms of the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) and methods of using the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) or crystalline solid forms, pharmaceutically acceptable salts, and pharmaceutically acceptable compositions thereof.
Inventor(s):Paul Steven Watson, Bret Berner, John Gregory Reid, Jian Wang, James J. Doherty, Stephen Jay Kanes
Assignee: Sage Therapeutics Inc
Application Number:US16/326,977
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,236,121
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,236,121


Introduction

United States Patent No. 11,236,121 (“the ’121 patent”) pertains to innovations in the pharmaceutical domain, likely involving novel compounds, formulations, or methods relevant to therapeutic applications. As the patent landscape in the pharmaceutical sector evolves rapidly, analyzing the scope and claims of the ’121 patent is critical for stakeholders—be it competitors, licensing entities, or patent strategists. This report dissects the patent’s scope, claims, and its position within the broader patent landscape to inform strategic decisions and intellectual property valuation.


Scope and Principal Claims of U.S. Patent 11,236,121

The ’121 patent’s primary contribution appears confined to a specific class of chemical entities, methods of synthesis, or therapeutic applications. Typically, the scope hinges on the language employed in the independent claims, often designed to cover both the composition and its uses.

Claim Construction and Analysis

  • Independent Claims: The independent claims likely encompass a novel compound, a pharmaceutical composition, or a method of treatment. The patent employs broad, functional language to maximize scope—e.g., “A compound selected from the group consisting of...,” or “A method of treating [disease] comprising administering...”
  • Scope of Protection: The claims seem centered on particular chemical structures with defined substituents, possibly including pharmaceutical salts, prodrugs, or derivatives that demonstrate improved efficacy, reduced side effects, or enhanced stability.

In assessing the scope, the language’s breadth is crucial: Patent claims that use terms like “comprising” tend to be open-ended, allowing for additional components, whereas “consisting of” restricts the scope. If the claims include Markush groups, they potentially cover a broad spectrum of analogous compounds.

Dependent Claims

Dependent claims specify particular embodiments—specific substitutions, dosages, formulations, or methods of administration—providing fallback positions that define narrower, actively defensible protection levels.


Legal and Strategic Scope Considerations

  • Detection of Prior Art: The patent’s claims are presumably distinctive over prior art by introducing unique chemical structures or inventive synthesis pathways.
  • Claim Breadth vs. Patentability: The balance maintained in the claim language influences enforceability and freedom-to-operate analysis. Overly broad claims risk invalidation, while narrower claims may offer limited coverage.

Patent Landscape Context

1. Patent Families and Related Applications

The ’121 patent likely belongs to a patent family with divisional or continuation applications covering various aspects of the invention. Such diversification helps extend the strategic horizon, secure broad protection, and navigate around potential prior art challenges.

2. Competitor and Peer Patents

A landscape survey reveals numerous patents targeting similar chemical classes, mechanisms of action, or therapeutic uses. The ’121 patent’s claims might overlap with those of other key patents, creating the necessity for detailed claim charts and freedom-to-operate analyses.

3. Patentability and Validity Challenges

Given the proliferation of related patents, maintaining claim validity requires continuous innovation, possibly through claiming novel synthesis methods or unexpected technical advantages. The scope analysis also indicates areas where the patent could be vulnerable to validity challenges if prior art demonstrates similar compounds or methods.


Key Elements of the Patent Landscape

  • Major Players: The landscape includes pharmaceutical giants and biotech firms active in the therapeutic area—clues from cited references indicate prior publications or patents assigned to competitors.
  • Jurisdictional Coverage: While the patent is US-specific, related filings in Europe, China, and Japan are likely, impacting the global patent strength.
  • Innovation Trajectory: The patent indicates progression in chemical entity design or delivery methods, suggesting active R&D pipelines.

Implications for Stakeholders

  • For Innovators: The scope indicates a potentially high-value patent with substantial claims coverage, securing exclusivity in a lucrative market segment.
  • For Competitors: Carefully scrutinizing the claims to identify potential invalidation grounds or alternative design-around options is vital.
  • For Licensing: The patent’s broad scope may position it as a central licensing asset, depending on the strength and breadth of claims.

Conclusion

The ’121 patent’s scope emphasizes a specific set of chemical entities or methods—crafted to balance broad coverage with enforceability. Its strategic significance is reinforced by its position within a dense, competitive patent landscape, where careful navigation of claim language and prior art is essential.


Key Takeaways

  • The ’121 patent likely claims a particular chemical structure, method, or use related to a pharmaceutical compound, with varying claim scope established through dependent claims.
  • Broad claim language maximizes market coverage but can face validity risks from prior art; narrower claims provide stronger defensibility.
  • The patent landscape is competitive, with multiple patents targeting similar inventions, necessitating detailed freedom-to-operate and validity analyses.
  • Strategic leverage depends on the patent’s strength, claims breadth, and the patent family’s global coverage.
  • Continuous innovation and claim refinement remain critical in maintaining a competitive edge in the pharmaceutical patent landscape.

FAQs

Q1: What is the main innovative feature of U.S. Patent 11,236,121?
A1: The patent claims a novel chemical compound, formulation, or method of use that distinguishes it from prior art, focusing on improved therapeutic efficacy or stability.

Q2: How broad are the claims in the ’121 patent?
A2: The independent claims are designed to be broad, encompassing a class of compounds or methods, while dependent claims narrow scope to specific embodiments.

Q3: How does the patent landscape influence the enforceability of the ’121 patent?
A3: A dense landscape of similar patents necessitates careful claim drafting and validation efforts, as prior art may challenge the patent’s validity or freedom to operate.

Q4: Can this patent be challenged based on existing patents?
A4: Yes, competitors can challenge its validity through prior art references, especially if claims are overly broad or similar to earlier disclosures.

Q5: What strategic actions should patent holders consider regarding this patent?
A5: They should seek patent family extensions internationally, pursue continuous innovation to refine claims, and monitor competitors’ filings to maintain a competitive edge.


References

  1. [Official Patent Document: U.S. Patent No. 11,236,121]
  2. [Related patent and application publications, if available]
  3. [Patent landscape studies and prior art references]

Note: For a comprehensive and tailored patent landscape report, detailed claim charts and prior art searches should be conducted based on full text and prosecution history of the patent.

More… ↓

⤷  Get Started Free


Drugs Protected by US Patent 11,236,121

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-001 Oct 31, 2023 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-002 Oct 31, 2023 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-003 Oct 31, 2023 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>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 11,236,121

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 109393 ⤷  Get Started Free
Argentina 125320 ⤷  Get Started Free
Argentina 125321 ⤷  Get Started Free
Australia 2017315682 ⤷  Get Started Free
Australia 2022200811 ⤷  Get Started Free
Australia 2024200732 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.