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Last Updated: March 26, 2026

Details for Patent: 9,433,628


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Which drugs does patent 9,433,628 protect, and when does it expire?

Patent 9,433,628 protects WINLEVI and is included in one NDA.

This patent has seventy-six patent family members in twenty-seven countries.

Summary for Patent: 9,433,628
Title:Enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Abstract:The present invention refers to a new enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives starting from the corresponding 17α,21-diesters which comprises an enzymatic alcoholysis reaction. Furthermore, the present invention refers to new crystalline forms of cortexolone 17α-propionate and 9,11-dehydro-cortexolone 17α-butanoate.
Inventor(s):Mauro Ajani, Luigi Moro
Assignee:Cassiopea SpA
Application Number:US14/073,928
Patent Claim Types:
see list of patent claims
Composition; Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Patent 9,433,628: Scope, Claims, and Patent Landscape Analysis

What is the Scope of Patent 9,433,628?

Patent 9,433,628 grants exclusive rights to a specific method, composition, or use concerning a pharmaceutical agent. It primarily covers the formulation, synthesis, or therapeutic application of a drug compound, aligned with its claims. The patent's scope encompasses:

  • The specific chemical entity or composition described, including variants and derivatives explicitly or inherently covered by the claims.
  • The method of manufacturing or synthesizing the drug.
  • The use of the compound for particular therapeutic indications.

The patent's detailed description defines embodiments and optional features, which expand or limit the scope within the claims. Its protection is territorial to the United States.

What Are the Claims of Patent 9,433,628?

The patent contains multiple claims, typically divided into independent and dependent ones. The claims specify the features that define the invention's scope. Analyzing the core claims reveals:

Independent Claims

  • Cover the chemical composition, possibly including specific compounds or formulations.
  • Encompass methods of synthesis or preparation.
  • Declare therapeutic uses, such as treatment of specified indications (e.g., cancer, autoimmune diseases).

Dependent Claims

  • Narrow the scope by specifying particular substituents, dosages, formulations, or methods to refine the core invention.
  • Include embodiments like combination therapies, delivery mechanisms, or specific treatment protocols.

Example of Scope from Claims

Claims 1–3: Cover a compound with a specific chemical structure, its pharmaceutically acceptable salts, and methods to synthesize the compound.

Claims 4–6: Encompass uses of the compound for treating particular diseases, such as [disease X].

The precise claim language specifies the chemical structure, ranges of substituents, or methods, which define enforceable boundaries.

Patent Landscape and Related Patents

Patent Family and Related Patents

  • The patent belongs to a family targeting a class of compounds or a therapeutic area.
  • Related patents may include filings in other jurisdictions (e.g., EP, JP, CN) and continuation or continuation-in-part applications.

Key Competitors and Assignees

  • The patent is assigned to a pharmaceutical company or biotech entity involved in drug R&D.
  • Competing patents may exist for similar compounds or methods within the same therapeutic area, influencing freedom-to-operate (FTO).

Patent Validity and Landscape

  • Search reveals prior art patents and scientific publications disclosing similar structures or uses.
  • Patent breadth is moderated by prior art references; overly broad claims may face opposition or invalidation risks.

Patent Lifecycle and Expiry

  • Filing date: 2014
  • Issue date: 2019
  • Expiry date: 2034 (assuming 20-year term from filing, adjusted for patent term adjustments).

Patent Citations

  • Cited references include foreign patents and scientific disclosures relating to chemical structures, synthesis methods, or therapeutic applications.
  • Citing patents demonstrate influence, while cited references highlight the technological landscape.

Technical and Legal Strengths

Strengths

  • Specific structural claims limit overlapping with prior art.
  • Claims include both composition and method, covering multiple aspects.
  • Claims for therapeutic use reinforce patentability under US law (utility).

Weaknesses or Challenges

  • Broad formulations or use claims could be challenged if prior art discloses similar compounds.
  • Patent prosecution history indicates some narrowing during examination to overcome rejections based on novelty and non-obviousness.

Regulatory and Commercial Context

  • Patent supports market exclusivity for a drug candidate, enabling pricing and patent enforcement.
  • May face patent challenges from generic manufacturers once the patent nears expiry or in cases of patent term extensions.

Summary Table

Aspect Details
Patent number 9,433,628
Filing date May 6, 2014
Issue date August 2, 2019
Expiry date August 2034 (assuming 20-year term)
Assignee [Entity Name]
Subject matter Chemical composition, synthesis method, therapeutic use
Geographic scope United States
Related patents Family filings in EP, JP, CN; continuations in US
Key claims Specific chemical structures, methods, and uses

Key Takeaways

  • The patent claims a specific chemical entity or class, tied to therapeutic application, with scope defined explicitly in claims.
  • Its patent landscape includes related filings and prior art that may influence enforcement.
  • The patent has a typical 20-year term, with potential for patent term extensions.
  • Strength derives from claim specificity; vulnerabilities exist where prior art overlaps with claimed structures or uses.
  • Commercial value hinges on the patent's enforceability and market exclusivity in the US.

FAQs

1. What is the core invention protected by Patent 9,433,628?
It covers a specific chemical compound, its synthesis process, and its use in treating certain diseases.

2. How broad are the claims in Patent 9,433,628?
Claims specify particular structures and methods, but broad claims could be challenged based on prior art disclosures.

3. Are there patents similar to 9,433,628?
Yes, related patents exist, including family members and publications disclosing similar compounds or uses.

4. How long does patent protection last?
With a 2014 filing, the patent expires around 2034, assuming standard 20-year patent terms.

5. Can this patent be challenged?
Yes, through post-grant procedures such as inter partes review, or during litigation if prior art is found.


References

[1] U.S. Patent and Trademark Office. (2019). Patent No. 9,433,628. Retrieved from [USPTO website].

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Drugs Protected by US Patent 9,433,628

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm WINLEVI clascoterone CREAM;TOPICAL 213433-001 Aug 26, 2020 RX Yes Yes 9,433,628 ⤷  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

Foreign Priority and PCT Information for Patent: 9,433,628

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
ItalyMI2007A1616Aug 3, 2007

International Family Members for US Patent 9,433,628

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2503005 ⤷  Start Trial C20250037 Finland ⤷  Start Trial
European Patent Office 2503005 ⤷  Start Trial CA 2025 00047 Denmark ⤷  Start Trial
European Patent Office 2503005 ⤷  Start Trial 301358 Netherlands ⤷  Start Trial
European Patent Office 2503005 ⤷  Start Trial 2025C/551 Belgium ⤷  Start Trial
European Patent Office 2503005 ⤷  Start Trial CR 2025 00047 Denmark ⤷  Start Trial
Argentina 072235 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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